Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial.

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The Happy Talk trial tests if a community embedded, targeted selective speech and language programme that simultaneously engages with parents and early childhood educators, (1) improves language outcomes in children aged between 2 years 10 months and 6 years and (2) is cost effective for the health care system. Method The Happy Talk trial is a large scale cluster randomised trial of a 12-week manualised intervention delivered in pre/school settings serving socially disadvantaged communities, in Ireland. Seventy-two clusters will receive the intervention (12 participants per cluster). Parents and pre/school staff engage in group training and coaching in the form of 12 1-hour sessions for parents and four staff workshops, over the course of the pre/school year. Training/coaching includes core interaction skills (modelling, expanding, balancing questions and comments), early literacy and phonological awareness. Blinded assessments pre- and immediately post-intervention and at 6 months follow up, will measure the primary outcomes of children’s receptive and expressive language and functional impact, and secondary outcomes of quality of life. Parental responsiveness and educator-child interactions will also be evaluated. Discussion This robust study evaluates a public health approach to the delivery of speech language and communication intervention in the ‘real world’ in the community, which focuses on prevention and equity of access. Pilot work indicates that the programme is feasible, acceptable to parents and staff, cost effective, and suitable for implementation at scale. The trial includes a process evaluation, a well-developed economic evaluation and the outcomes are directly relevant to children, families and educators. This work has the potential to improve the long-term outcomes and life chances of people living in social disadvantage. Trial registration clinicaltrials.gov NCT06460090 Trial Management There is a formal governance structure to oversee the conduct and running of the trial, consisting of a trial management group and a steering committee. More details on the composition, roles and responsibilities of each committee can be found in the supplemental material. " } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://hrbopenresearch.org/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://hrbopenresearch.org/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://hrbopenresearch.org/articles/7-65/v3", "name": "Evaluating a targeted selective speech, language, and communication..." } } ] } Home Browse Evaluating a targeted selective speech, language, and communication... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Frizelle P, O'Shea A, Murphy A et al. Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.12688/hrbopenres.13973.3 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Revised Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] Pauline Frizelle https://orcid.org/0000-0002-9715-3788 1 , Aoife O'Shea 2 , Aileen Murphy https://orcid.org/0000-0003-3062-0692 3 , Darren Dahly 4 , Cristina McKean https://orcid.org/0000-0001-9058-9813 5 Pauline Frizelle https://orcid.org/0000-0002-9715-3788 1 , Aoife O'Shea 2 , [...] Aileen Murphy https://orcid.org/0000-0003-3062-0692 3 , Darren Dahly 4 , Cristina McKean https://orcid.org/0000-0001-9058-9813 5 PUBLISHED 31 Jan 2025 Author details Author details 1 Department of Speech and Hearing Sciences, School of Clinical Therapies, University College Cork, Cork, Ireland 2 Speech and Language Therapy Department, Health Services Executive, Cork, Ireland 3 Department of Economics, University College Cork, Cork, Ireland 4 School of Public Health, University College Cork, Cork, Ireland 5 Department of Education, Oxford University, Oxford, UK Pauline Frizelle Roles: Conceptualization, Funding Acquisition, Project Administration, Writing – Original Draft Preparation Aoife O'Shea Roles: Investigation, Project Administration Aileen Murphy Roles: Formal Analysis, Methodology, Visualization, Writing – Review & Editing Darren Dahly Roles: Data Curation, Formal Analysis, Methodology, Visualization, Writing – Review & Editing Cristina McKean Roles: Conceptualization, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS Abstract Background In areas of social disadvantage up to 40–50% of children enter preschool with speech and language skills significantly poorer than would be expected for their age. The Happy Talk trial tests if a community embedded, targeted selective speech and language programme that simultaneously engages with parents and early childhood educators, (1) improves language outcomes in children aged between 2 years 10 months and 6 years and (2) is cost effective for the health care system. Method The Happy Talk trial is a large scale cluster randomised trial of a 12-week manualised intervention delivered in pre/school settings serving socially disadvantaged communities, in Ireland. Seventy-two clusters will receive the intervention (12 participants per cluster). Parents and pre/school staff engage in group training and coaching in the form of 12 1-hour sessions for parents and four staff workshops, over the course of the pre/school year. Training/coaching includes core interaction skills (modelling, expanding, balancing questions and comments), early literacy and phonological awareness. Blinded assessments pre- and immediately post-intervention and at 6 months follow up, will measure the primary outcomes of children’s receptive and expressive language and functional impact, and secondary outcomes of quality of life. Parental responsiveness and educator-child interactions will also be evaluated. Discussion This robust study evaluates a public health approach to the delivery of speech language and communication intervention in the ‘real world’ in the community, which focuses on prevention and equity of access. Pilot work indicates that the programme is feasible, acceptable to parents and staff, cost effective, and suitable for implementation at scale. The trial includes a process evaluation, a well-developed economic evaluation and the outcomes are directly relevant to children, families and educators. This work has the potential to improve the long-term outcomes and life chances of people living in social disadvantage. Trial registration clinicaltrials.gov NCT06460090 Trial Management There is a formal governance structure to oversee the conduct and running of the trial, consisting of a trial management group and a steering committee. More details on the composition, roles and responsibilities of each committee can be found in the supplemental material. READ ALL READ LESS Keywords Language development, Language development disorders, Public Health, Early intervention, Outcome assessment, Child development, Cluster randomized controlled trial. Corresponding Author(s) Pauline Frizelle ( [email protected] ) Close Corresponding author: Pauline Frizelle Competing interests: No competing interests were disclosed. Grant information: Health Research Board Ireland [DIFA 2023 001]. This work was also supported by the Irish Health Services Executive. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2025 Frizelle P et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Frizelle P, O'Shea A, Murphy A et al. Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.12688/hrbopenres.13973.3 ) First published: 08 Oct 2024, 7 :65 ( https://doi.org/10.12688/hrbopenres.13973.1 ) Latest published: 31 Jan 2025, 7 :65 ( https://doi.org/10.12688/hrbopenres.13973.3 ) Revised Amendments from Version 2 In this updated version we have Included 'compared to usual care' in our first RQ Clarified that responsiveness relates to language promoting behaviours Acknowledged that those randomly chosen will experience varying degrees of disadvantage Removed the request for participants to have level B2 English, parents will be included on the basis that their English is sufficient for them to comfortably complete the outcome measures. Highlighted that feasibility and acceptability has been well established in previous research and organically through the development of the programme over many years Clarified that intervention sessions are audio recorded, using a microphone aimed at capturing SLT audio only Added references and example statements for the FOCUS-34 Noted that parental and educators’ intervention attendance levels will be documented Clarified the reliability check on PLS-5 scoring Provided additional information on data management Made more explicit that the PLS-5 and the FOCUS- 34 will be used in the secondary economic evaluation analysis. In this updated version we have Included 'compared to usual care' in our first RQ Clarified that responsiveness relates to language promoting behaviours Acknowledged that those randomly chosen will experience varying degrees of disadvantage Removed the request for participants to have level B2 English, parents will be included on the basis that their English is sufficient for them to comfortably complete the outcome measures. Highlighted that feasibility and acceptability has been well established in previous research and organically through the development of the programme over many years Clarified that intervention sessions are audio recorded, using a microphone aimed at capturing SLT audio only Added references and example statements for the FOCUS-34 Noted that parental and educators’ intervention attendance levels will be documented Clarified the reliability check on PLS-5 scoring Provided additional information on data management Made more explicit that the PLS-5 and the FOCUS- 34 will be used in the secondary economic evaluation analysis. See the authors' detailed response to the review by Nicola Botting See the authors' detailed response to the review by Naja Ferjan Ramirez and Adeline Braverman See the authors' detailed response to the review by Heidi Feldman See the authors' detailed response to the review by Meredith L. Rowe READ REVIEWER RESPONSES Background Language is an important health outcome because it is a key predictor of quality of life ( Field, 2010 ), social-emotional and behaviour difficulties ( Qi & Kaiser, 2003 ) as well as mental health and employment outcomes ( Clegg et al. , 2005 ; Law et al. , 2009 ). If language difficulties are untreated, there are long-term health, educational and societal consequences ( Law et al. , 2009 ), which in turn place a significant economic burden on society. Moreover, in recent years the effects of these difficulties have been further exacerbated by the COVID-19 pandemic ( Erbay & Tarman, 2022 ; Nelson et al. , 2021 ). Language in the context of social disadvantage Although rates of language difficulty are reported to vary considerably (e.g. Norbury et al. , 2016 ; Tomblin et al. , 1997 ), literature converges on the view that children from disadvantaged backgrounds have disproportionately higher rates of language difficulty than their more affluent peers ( McKean et al. , 2018 ; Morgan et al. , 2015 ; Nelson et al. , 2011 ). This higher rate of language difficulty has been documented in children as early as 18 months ( Fernald et al. , 2013 ; McGillion et al. , 2017 ), and without intervention, does not remediate as children progress through primary and secondary schooling ( Duncan & Magnuson, 2011 ). Children with such persisting difficulties being eligible for a diagnosis of DLD. In the US, Nelson and colleagues reported as many as 65% of children living in social disadvantage met the criteria for a clinically significant language impairment ( Nelson et al. , 2011 ). While in the UK, Locke and colleagues (2002) reported a prevalence of 50% of children living in significant deprivation, starting preschool with lower levels of language than would be expected for their age. Similarly, Law et al. (2011) reported an almost 40% prevalence rate in slightly older Scottish children (5 – 12 years), living in considerable social disadvantage. Applying these figures to the 30% of children living in poverty in the UK would indicate that there are between 1.7 and 2.15 million children with language skills not at their expected level and not attributable to a specific diagnosis. Moreover, a teacher report published by Speech and Language UK (2023), indicated a 26% increase in children with language difficulties in the previous two years. Historically, the association between social disadvantage and lower language levels was primarily attributed to children experiencing fewer examples of rich language input ( Hart & Risley, 1995 ), fewer opportunities for quality caregiver–child interactions, and parenting styles that are less responsive to children’s interests ( Landry et al. , 2001 ). However, while these factors do mediate children’s language development ( Morgan et al. , 2015 ), more recent research has highlighted the complexity and multiplicity of components at play in attempting to explain the relationship between poor language and social disadvantage ( Law et al. , 2019 ). In particular the issue of access and engagement with services has been highlighted as problematic ( Moore et al. , 2015 ), and a key consideration in the design and implementation of interventions ( McKean & Reilly, 2023 ; Reilly & McKean, 2023 ). Given the high rates of language difficulty and the consequences that these difficulties have on children’s lives, coupled with issues of access, providing effective and efficient interventions that are accessible for all groups is a clear priority, to achieve improved health outcomes in socially disadvantaged populations. One of the best ways to ensure access and participation and therefore to increase the impact and reach of early language interventions, is through interventions that are universal, preventative, and embedded within community based organisations with which parents are already engaging. Early childhood educator professional development programmes One approach to support children’s development in naturalistic community based environments is through the use of early childhood educator professional development programmes. Programmes have been developed with the aim of training early childhood educators in evidence-based techniques and practices that create language rich environments and encourage responsive styles of interaction. By enhancing educators’ knowledge and optimising their use of language promoting techniques, it is hypothesized to have a cascading effect, improving children’s language outcomes. This is supported by the empirical literature which shows that high quality early childhood education can mitigate the effects of poverty in relation to preschool language ( Lim et al. , 2022 ; Marulis & Neuman, 2013 ; Schachter, 2015 ). In broad terms, early childhood educator professional development programmes tend to have a primary focus, either on educator–child responsive interactions, or on literacy. Consequently, outcomes are very variable and findings in relation to child language outcomes are inconsistent. With respect to professional development interventions focusing on educator-child responsive interactions, Eadie et al. (2019) and Cabell et al. (2011) reported no effects on child language outcomes. In contrast, Yazejian et al. (2020) and Piasta et al. (2012) reported positive (albeit modest) effects in relation to auditory language skills and linguistic productivity respectively. Professional development programmes with a literacy focus tend to report more consistent positive findings, particularly in relation to the specific areas being targeted e.g. letter knowledge, concepts about print and phonological awareness ( Markussen-Brown et al. , 2017 ; Powell et al. , 2010 ). However, positive impact of these programmes on broader language outcomes, such as vocabulary, is less consistent ( Landry et al. , 2009 ; Markussen-Brown et al. , 2017 ; Wasik & Hindman (2011) . Nonetheless, studies do indicate a positive impact on educators, such as an increase in the instructional quality of their teaching ( Bowne et al. , 2016 ; Eadie et al. , 2019 ) and the use of sensitive/ responsive strategies ( Landry et al. , 2017 ). There are many reasons that may explain why these effects do not seem to translate into positive gains for children’s language outcomes, not least the timing of outcome measures and the absence of follow up /longitudinal data. It may also be that positive changes in one environment are not sufficiently intense or consistent to be reflected in children’s language skills either in the short- or long-term. One potential solution to this is to engage with parents with the aim of increasing parent responsiveness and support for language in children’s home environments. Parent-mediated intervention programmes Parent-mediated interventions are preventative approaches, frequently used with socially disadvantaged families which aim to train parents in the use of responsive and contingent interactions with their child. These interventions are based on the premise that parent-child interactions and the activities that parents and children share together offer opportunities for promoting early language learning. Parents are taught strategies to interact responsively, to support mutual engagement with their child and provide a higher quantity of verbal input, matched to their child’s interests and developmental level ( Golinkoff et al. , 2015 ; Hoff, 2006 ; Rowe & Snow, 2020 ). Subsequently, they are encouraged to use these interactive and linguistic strategies in everyday routines such as playtime, shared book reading etc. This approach is supported by the empirical literature, in that parent-child interactions with specific qualities (responsive, contingent and developmentally appropriate) are associated with better language outcomes ( Levickis et al. , 2023 ; Madigan et al. , 2019 ). However, although usually greater for children from disadvantaged backgrounds, effect sizes are often modest. Based on two meta-analyses of parent behaviour and child language, Madigan and colleagues (2019) reported a weak association between sensitive responsive parenting and child language, with effect sizes stronger in those with low SES. In a more recent meta-analysis Jeong et al. (2021) also reported relatively modest positive effects of parenting interventions on children’s language development, standard mean difference = 0.28, 95% CI: 0.18 to 0.37, p < 0.001), again with significantly greater effects on children from low- compared to high-income countries. In an additional meta-analysis Roberts et al. (2019) explored the association between parent training (naturalistic and dialogic reading) and child language development and reported moderate effect sizes for children at risk, in relation to receptive language (mean Hedges g [SE] = 0.28 [0.15]) and engagement outcomes (mean Hedges g [SE] = 0.36 [0.17]). Overall, in the short term, pooled effect sizes for parent mediated interventions for those living in social disadvantage are at best moderate and it would seem that, similar to professional development programmes, this approach alone is not sufficient to support children living in these circumstances. Interventions engaging with parents and early childhood educators Despite relatively modest effects for programmes that are aimed solely at either early childhood educators or parents/caregivers, studies of programmes that simultaneously engage with both groups are relatively scarce ( Greenwood et al. , 2020 ), particularly for those with child language outcome measurements. By providing an intervention in more than one environment, to two sets of people who spend a significant amount of time with the child, the expectation is that the exposure to responsive interactions and language-promoting strategies will increase. This, in turn, is hypothesized to increase the language gains for the child. Findings by Frizelle et al. (2021a) (Happy Talk); Gibbard et al. (2024) (Enhanced parent based intervention) and Stevens et al. (2019) , (Abecedarian approach) support this hypothesis. Frizelle et al. (2021a) carried out pilot effectiveness study and found that implementing a community-based speech language and communication programme (Happy Talk) that simultaneously engaged with parents and early childhood educators resulted in large effects (.6SD) on comprehension and moderate effects (.46SD) on a composite language measure (comprehension and expression), for children from areas of social disadvantage. In addition, the pilot trial indicated cost effectiveness ( Frizelle et al. , 2021b ), as well as feasibility and acceptability to parents and preschool staff, making Happy Talk suitable for implementation at scale. In an RCT, Gibbard et al. (2024) compared a parent mediated clinic-based intervention to one that included early years educators in a local children’s centre and reported greater effect sizes for almost all outcomes when a more integrated model of intervention delivery was used. In contrast, other studies have reported no additional child language benefits to carrying out an intervention in two environments (home and school) over one (home alone) ( Hargrave & Sénéchal, 2000 ; Landry et al. , 2017 ; Lonigan & Whitehurst, 1998 ). Therefore, while there is some evidence of an increased benefit to simultaneously engaging with parents/caregivers at home and early years educators in pre/school, the evidence is not conclusive. In addition, whether parent-mediated, early childhood educator focused, or both, many intervention studies are small with limited follow up; they tend to be ‘efficacy’ trials carried out in very controlled environments rather than ‘real world’ effectiveness studies based in the community; they are not pre-specified in a protocol and there are few replications. Moreover, there is a need for more longitudinal research as well as studies specifically focused on scaling-up interventions, including features such as community readiness and capacity, program acceptability and cost. The current work aims to build on the Happy Talk pilot trial by scaling up to a full definitive effectiveness trial carried out in the community, including follow up outcome measures to look at the longer term impact of the programme; a process evaluation and a societal cost benefit analysis at a larger scale. In doing so the work will address the aforementioned issues above. Objectives/ Hypotheses The Happy Talk trial aims to answer 3 specific research questions. 1. Does Happy Talk, a targeted selective intervention focused on increasing parent and early educator responsive interaction, improve language and quality of-life (QoL) outcomes in socially disadvantaged preschool and young school-aged children, compared to usual care? 2. Does Happy Talk enhance language promoting behaviours /responsiveness in home and pre/school contexts? 3. Is Happy Talk cost effective for the health care system compared to usual care? 4. What programme features support successful real-world application of ‘Happy Talk’ and how do contextual factors influence Happy Talk implementation/ outcomes? We hypothesize that compared to the control group 1. Children in the intervention group will have better mean scores on a. Receptive, expressive and total language score on the standardized language measure, the Preschool Language Scales (PLS-5) b. Focus on the Outcomes of Communication under Six (FOCUS) c. Paediatric Quality of Life Inventory (PedsQL) and Parent report for Toddlers and Child Health Utility instrument (CHU9D), we have delayed follow up measures to 1 year post to allow time for programme effects to translate into QoL impact. 2. Parents in the intervention group will have higher mean scores on the Maternal Responsive Behaviours Coding Scheme (MRBCS) 3. Early childhood education settings in the intervention group will have higher means scores on the Classroom Assessment Scoring System (CLASS) 4. The intervention will be cost effective for the health care system (measured against common decision thresholds). Methods The intervention will be evaluated using a cluster-randomized controlled trial taking place over three years. The trial will include two study cycles that each include a period for enrolling settings, baseline assessments, an 8 month intervention period, outcome assessments immediately post-intervention, and additional follow-up measures taken 6 months post-intervention, or 1 year post-intervention for QoL measures. The time schedule for enrolment, intervention delivery and assessments is given in Figure 1 . The process evaluation will involve two phases 1) a pre-trial evaluation examining factors which promote parental engagement and partnership between SLTs and educators with the aim of incorporating these into SLT training and future rollouts of the programme and 2) a concurrent evaluation from a realist perspective to examine how the mechanisms underpinning Happy Talk are influenced by the implementation context. A combination of surveys, interviews and focus group methodologies will be used. These will be reported on in more detail elsewhere. Figure 1. Time schedule for Enrolment, Assessments and Intervention delivery. Inclusion criteria The HSE in Ireland is divided into nine Community Healthcare Organisations (CHO) each of which has a chief officer who leads the local management team, who in turn govern all specialist services in their area, including primary care SLT. Pre/schools will be targeted for recruitment from 4 CHOs in Ireland for each trial cycle (8 in total) and will be selected based on levels of social disadvantage as indexed by the 2016 Pobal HP Deprivation Index. The index is a method of measuring the relative affluence or disadvantage of geographical area in Ireland. Inclusion criteria for pre/schools are as follows: Those falling within the Health Services Executive Community Healthcare Organisation (CHO) area for which support has been offered. Those attached to DEIS schools (Delivering Equality of Opportunity in Schools i.e., those including a high concentration of students from socioeconomically disadvantaged backgrounds) Child and Family Resource centres (established in Ireland for children from disadvantaged backgrounds). Pre/schools who are not in receipt of another early years language intervention programme that is not part of standard care. While all children of the appropriate age, their parents, and all staff in each intervention setting will be offered the programme, it is not feasible to assess all children in each setting in the time frame before pre/school starts at the beginning of the academic year. To ensure adequate power, of those that consent to be part of the evaluation, 12 participants from each cluster will be randomly chosen for inclusion. We appreciate that those randomly chosen may experience varying degrees of disadvantage. We will collect this demographic information and note individual differences. This variation will also exist within the control settings and therefore should not be a confounding variable. Exclusion criteria Children who are known to have an intellectual disability, or who are non-English speaking will be excluded from the evaluation. Children for whom English is a second language will not be excluded if parents report that they are comfortable completing the outcome measures without the need for interpreters. Interventions Active intervention The active intervention under evaluation is Happy Talk, a manualized training and support programme delivered by SLTs to parents and early childhood educators in socially disadvantaged areas. The overall programme aims to support children between 0 and 6 years. However, the focus of this trial is solely on the preschool/Junior infant class programme (children aged between 2;10 and 5,11 years). The programme is informed by general systems theory ( Lazlo, 1972 ) and is embedded in the preschools, and homes of socially disadvantaged children with the aim of effecting change in parent and educator behaviour (see Figure 2 Happy Talk Logic Evaluation model). Figure 2. Happy Talk Logic Evaluation Model. Parent component: This includes twelve in person 1-hour sessions delivered in 4 week blocks and in two 30-min units, over the three terms of the pre/school year (September–December, January–March and April–June). For the first 30 minutes of each session, parents (mothers, fathers and occasionally other family members) engage in live group training with the SLT in a room within the pre/school. This is followed by 30 minutes of in person coaching, with parents practicing their newly acquired skills with their children in the pre/school, while they are guided and scaffolded by the SLT. The skills targeted in the programme include listening skills; modelling and expanding language; balancing questions and comments; practicing language promoting techniques during free play; phonological awareness (such as rhythm, blending and segmenting syllables); learning new words; pretend play through stories; and bringing books alive. Pre/school staff component and communication champions: Prior to delivering the staff components of the intervention, therapists engage with each pre/school setting for a period of 2 to 3 weeks to share and schedule how Happy Talk will be delivered over the coming year; discuss maximising parental engagement and attendance; and conduct a parent information session. The aim of this engagement is to begin developing relationships, and to work together as a community prior to inviting parents to participate in the Happy Talk programme. Pre/school staff complete four workshops in total. Workshop 1 takes place in each pre/school before the 12-week parent programme begins. The workshop focuses on the three core interaction skills to be covered with parents in term 1 (modelling, expanding and balancing questions and comments) as well as early literacy and phonological awareness skills. The workshop gives staff the opportunity to practice these skills using a range of pre/school toys and is followed by a 30-min coaching session where staff practice using the skills under the SLT’s supervision, prompting and guidance. Workshops 2 – 4 take place following each 4-week parent intervention block. These workshops include the following core components revision of the interaction skills previously outlined sharing language rich environment resources giving information on language development in young children and on identifying children with speech, language, and communication needs sharing speech and language tools that aid with the transition from preschool to school. The number of staff attending the workshops will vary according to the setting i.e. the number of pre/school rooms/classes within a given setting receiving Happy Talk. In addition to these workshops each room is asked to nominate at least one communication champion who commits to attending three Communication Champions workshops over the course of the academic year. These workshops focus on providing staff with the skills necessary to support the successful implementation of Happy Talk in their setting. Optional themes include multiculturalism; early literacy; engaging parents; and identifying speech, language and communication needs. Workshops are delivered once a term, and last 2.5 – 3 hours. The Happy Talk pre/school program is very well established and has been successfully implemented in 72 settings in one region in Ireland over the past 12 years. The feasibility and acceptability of the programme to parents and pre/school staff has therefore been established. Fidelity. Each aspect of the Happy Talk programme is outlined in a manual which has been introduced as part of the SLT training to facilitate Happy Talk. Training included 1) how to coach parents and staff, 2) how to engage parents 3) how to work in disadvantaged communities and 4) how best to build social capital between therapists, parents, and early years educators, with the aim of increasing engagement with the intervention. The Happy Talk team administering the training will complete self-evaluation checklists for adherence to the core key elements and SLTs who attended the training will complete learning evaluation checklists. To ensure SLT fidelity (for both parent and early educator components of the intervention) therapists will complete self-evaluation treatment fidelity checklists following each workshop and training and coaching sessions and adherence will be checked against the protocol laid out in the manual. All sessions will be audio recorded using a microphone worn by the interventionist, set at a level intended to capture their audio only. Each week two members of the research team will observe and review 20% of the recorded sessions and will independently complete the same fidelity checklists as those completed by the SLTs. In addition, dosage and accuracy with which clinicians deliver the elements specified in the manual, will be noted, and extrapolated up from the 20% viewed. Checklists completed by the SLTs will be compared with those completed by the research team and feedback will be provided. Overall fidelity will be calculated by summing scores for each of the individual components where there is agreement. Furthermore, the 8 SLT interventionists (4 each year) will be given ongoing support throughout the intervention through a once weekly video or audio call from the lead Happy Talk clinician. Comparator interventions Comparator interventions are the ‘business as usual’ Early Childhood Care and Education programme (ECCE)) and national Junior infant class curriculum. The ECCE programme is a national universal two-year pre-school programme available to all children between 2yrs 8 months and 5yrs 6 months. It provides children with their first formal experience of early learning prior to commencing primary school. The programme is provided for three hours per day, five days per week over 38 weeks per year and the programme year runs from September to June each year. Childcare services taking part in the ECCE programme must provide an appropriate pre-school educational programme which adheres to the principles of Síolta, the national framework for early years care and education. The most commonly implemented programme is ‘Aistear’ which is based on 12 principles of early learning and development, presented in three groups 1) children and their lives in early childhood 2) children’s connections with others and 3) how children learn and develop. Communication and language is one element of the third component. Junior infants is the first year of an 8 year cycle in primary education. The primary curriculum is presented in 7 areas: Art; Mathematics, Social Environmental and Scientific Education; Physical Education; Religious Education; Primary Language; and Social, personal and Health Education. Any children who are receiving SLT in the community can continue to do so throughout the trial. Outcomes Primary- child The Pre-school Language Scales – 5 th Edition (PLS 5) ( Zimmerman et al. , 2014 ) is a standardized norm referenced language assessment that yields standard scores for total language, auditory comprehension, and expressive communication. A standard score of 100 represents the performance of a typical child at a given age. Standard scores between 85 and 115 correspond to one standard deviation below and above the mean, respectively; scores within this range are considered to be within normal limits. The Focus on the Outcomes of Communication Under Six (FOCUS-34) ( Oddson et al. , 2019 ; Thomas-Stonell et al. , 2010 ) is a clinical tool designed to evaluate change in communicative-participation in preschool children. We have obtained a copyright license to use this tool. The parent form consists of 34 statements, aimed at taking a snapshot of children’s skills as they are on that day. Example statements include, my child can tell stories that make sense; my child will ask for things from other children . Parents are asked to rate each statement using a 7 point scale, ranging from ‘not at all like my child’ to ‘exactly like my child’. This yields a total score ranging from 50 to 350 with a higher score indicating a better outcome. Secondary - child PedsQL TM ( Buck, 2012 ) is a standardized, parent proxy-report scale of health-related QoL in young children. The PedsQL contains 23 items and measures four health dimensions: physical, emotional, social, and school functioning (questions related to school or daycare if attended). The tool asks, “please tell us how much of a problem each item has been for your child during the past one month.” Parents are required to rate each item on a scale of 0–4 (0 indicating never a problem and 4 almost always a problem). The ratings are tallied yielding a total score for each section, the higher score indicating a greater level of difficulty. The Child Health Utility instrument (CHU9D) ( Furber & Segal, 2015 ), (caregiver completed) is a generic preference- based measure, using parent report scales to measure health related quality of life, in young children. The CHU9D (for children < 5years) consists of 11 questions and parents are asked to base their responses on how their child is feeling on the day of completion. It consists of a descriptive system and a set of preference weights, which give utility values for each health state described by the descriptive system, allowing the calculation of QALYs ( Mpundu-Kaambwa et al. , 2017 ). Secondary - parent The Maternal Responsive Behaviours Coding Scheme (MRBCS - Levickis et al. , 2014 ) is an observational coding scheme of parent– child interaction. Implementation of the MRBCS yields a total number of occurrences for each of the four parental responsive behaviours (Expansions; Imitations; Responsive Questions; and Labels), for a given period. By summing the frequency scores for each behaviour, an overall score of parental responsiveness can be calculated. The higher the score the greater the number of parental responsive behaviours - yielding better outcomes. Secondary - setting The Classroom Assessment Scoring System (CLASS; La Paro & Pianta, 2003 ) is designed to assess the quality of interactions between teachers and students in the classroom. The CLASS measures three broad domains of teacher-student interactions (Emotional Support, Classroom Organization, and Instructional Support) which are assessed across 10 specific dimensions: positive climate, negative climate, teacher sensitivity, regard for student perspectives, behavior management, productivity, instructional learning formats, concept development, quality of feedback, and language modeling. Assessors observe classrooms for a minimum period of 2 hours and assign scores on each dimension using 7-point scale. Recruitment A short recruitment video will be made to explain the purpose of the study and what it entails. The clinical project manager, will meet with the local childcare committee manager; preschool managers; and school principals in each potential area, to answer any questions about the programme. Parents and early years educators will also be given information leaflets and two members of our PPI group will be involved in talking to parents and staff about the study. All preschool children enrolled in the National Childcare scheme (aged between 2 years and 8 months and 5 years and 6 months) or attending Junior Infants in the educational settings recruited for the project, their parents/caregivers, and a minimum of 1 educator at each setting, will be invited to participate in the project. It will be made explicit from the outset that all settings will not receive the intervention. Recruitment will take place over a period of two months (for each iteration). Pre/school managers/principals interested in having their educational setting participate in the project will provide verbal consent over the phone. Subsequently, they will receive a consent form via email, which will be collected by the team member responsible for conducting the research activities in the pre/school. Parents/caregivers that wish to participate in the project will be requested to return a signed consent form to the principal/manager of their school/preschool. Child participants will be recruited via their parents/caregivers. Data collection Baseline assessments (all outcome measures) will be completed for children, parents, and each pre/school setting before being randomised to the experimental or control condition. Outcome measures will also be administered immediately post intervention, and at 6 months follow up. In addition, quality of life measures will also be administered at 1 year follow up. Outcome measures will be administered by the two research assistants employed on the project and 12 additional research assistants employed for the assessment periods only (all of whom will have some experience administering standardized assessments). Demographic information will be gathered from families to establish socio-economic status at the level of the child (measured through education of the primary caregiver) and if there is any history of speech and language difficulties in the family. Background information about the children will also be gathered including any diagnosed hearing difficulties, exposure to additional languages or whether they are already attending SLT. All parents taking part in the evaluation will receive a 20 euro ‘child-focused’ voucher at each assessment time point. All settings will receive a series of children’s books and control settings will receive continued professional development workshops post-intervention. Parental and educators’ intervention attendance levels will also be documented. Training Training will be given in the administration and coding of each measure as follows. Assessors administering the PLS-5 will attend a training day with a senior SLT who has experience using this assessment. Assessors administering the FOCUS and the quality of life measures with parents, will be familiarised with each measure and attend a question/answer session about administration. Those administering The Maternal Responsive Behaviours Coding Scheme will complete a training protocol under the guidance of the author of the coding scheme, where they will rate videos which will be compared with the ratings of the author. A criterion of 80% agreement will be required before progressing to rate the study videos. Research assistants administering or involved in reliability checking of the Classroom Assessment Scoring System (CLASS) will attend a two-day Observation Training provided by a certified CLASS trainer. Assessors will be required to code video segments online. To pass reliability they will be required to score within 1 point of the master code on 80% of all codes given, across all ten CLASS dimensions. The observation training will be given by the chief investigator who will complete the CLASS train-the-trainer programme online. Data coding and reliability Primary Outcome Measures: PLS-5: Children’s responses will be scored live according to the instruction manual, while administering the assessment. A second research assistant blinded to the participants’ group allocation, will independently examine 20% of randomly selected assessments to determine the reliability of the online scoring (checking total raw score accuracy and conversion to standard scores). Point-to-point agreement will be calculated between scorers. FOCUS ©- Will be completed over the phone with parents. The research assistants will document parent responses. 20% of the forms will be randomly selected for rescoring. Secondary Outcome Measures: Child: QoL measures will be administered by phone and scored ‘live’ by the RAs during each phone interview. 20% of the forms will be randomly selected for rescoring. Parent: The MRBCS videos will be rated by an RA trained in the use of this measure, who is blind to time and group. 20% of the videos will be randomly selected for double coding by another RA, again blind to time and group. Pre/school: Trained testers will administer the CLASS independently ‘live’ in each pre/school (designated as primary observers). 20% of the settings will be randomly selected to be rated by an additional observer and reliability will be reported. Data management Quantitative variable measurements will be recorded in international standardized units. Variables will be recorded within Comma Separated Value (.csv) data tables and range checks will be conducted for data values. Data files will include meta-data identifying title, creator, keywords etc. in line with the Dublin Core Metadata Initiative. Accompanying data dictionaries will be developed in parallel. The Electronic Data Capture platform (Castor EDC) will be used throughout this project. The Castor EDC platform contains in-built audit trail supports and data validation processes aligned to enact FAIR data outputs. Qualitative data will be imported into an NVivo database to facilitate analysis. Data will be encrypted at rest and in transit, two-factor authentication at log in, and daily backup and file syncing. All data will be stored so that it is amenable to audit. The PI (Professor Pauline Frizelle) is responsible for data governance and the research team are working closely with the university data steward to create a comprehensive data management plan. RAs will digitise parents’ responses into Castor at collection Statistical considerations Planned sample size The trial is designed to have reasonable power to detect a modest intervention effect. Using a priori power calculations based on the goal of detecting an effect size of Cohen’s d = 0.25, with a power of 80%, an intra class correlation of .05 (with an average of 10 participants per cluster) and a standard significance level of 5%, the required number of clusters is 72. We targeted a modest effect size based partly on the 1) the pilot trial of Happy Talk ( Frizelle et al. , 2021b ), which showed standardized effect sizes of 0.6 SD ( p = 0.005), 0.21 SD ( p = 0.26) and 0.46 SD ( p = 0.01) for receptive, expressive and total language scores, respectively; 2) the empirical literature which shows an effect of d = 0.3 for expressive language ( Heidlage et al. , 2020 ); and 3) research showing that intervention effects are often reduced when implemented at scale ( Bleses et al. , 2021 ). Further, the sample size calculations are conservative in that they do not account for efficacy gains following from stratified randomization; subsequent statistical adjustment for said stratifiers; and additional, prognostic participant- and cluster-level covariates in analyses of the trial data. Finally, we will include an additional 2 participants per cluster to allow for loss to follow-up, based on retention figures from our pilot trial, resulting in a target of 864 total participants enrolled in the trial. Randomisation, allocation concealment and blinding At the start of each of the two study cycles, 36 of 72 settings will be randomly allocated to either the Happy Talk or the “business as usual” study arms following their enrolment. The randomization will be stratified by geographical region and preschool versus school and restricted within strata using a block size of 2. Then, from the consenting families within each setting, 12 children and their parents/ caregivers will be randomly chosen at the start of the school year for assessment of study outcomes. The randomization lists for both settings and children/families will be prepared under the Standard Operating Procedures of the HRB-CRF-UCC. Allocation concealment will be maintained through the use of a protected electronic database so that the allocation will only become available to interventionists, when pre/schools and their associated families have unambiguously consented and enrolled onto the trial and when baseline measures have been completed. The study will then be open label from that point, as both participants and study staff delivering the interventions will be aware of how settings were allocated. However, outcome assessors will remain blind to allocation, and the initial analyses of the study data will be done by a blinded study statistician. Data analysis Analyses of study outcomes will be done at the participant level, and not based on cluster level summaries of participant data. Further, while we don’t expect cross-over between study arms, all participants will be analysed as members of the arm they were randomized to. Further, given the pragmatic focus on the trial, participants’ data will be analysed without consideration for their degree of engagement, or lack thereof, with the study interventions (using an intention to treat analysis). Supplementary analysis will examine the impact of high versus low engagement across parents and educational settings. Given the Happy Talk design, between arm differences in the primary child language outcomes (PLS-5, FOCUS 34) measured immediately post-intervention and 6 months later will be estimated using linear mixed effects models for repeat measures ( Bell & Rabe, 2020 ) with a random effect for setting, and fixed effects for study arm, timepoint, baseline outcome scores, study cycle, and geographic region (following from the stratified randomization). We will also use a second set of similar models that further adjust for setting type and gender mix, and child age, primary caregiver education, family history of speech and language difficulties, diagnosed hearing difficulties, exposure to additional languages, and any current or previous SLT. Our estimates of between arm differences in timepoint specific outcomes will be reported alongside 95% frequentist confidence intervals without consideration for multiple comparisons ( Althouse, 2016 ). Missing data will be carefully evaluated and a plan for addressing them will be based on what we observe. However, our planned mixed effects models for repeat measures will produce unbiased estimates assuming data are missing at random ( Bell & Rabe, 2020 ), conditional on model covariates. Analyses for secondary outcomes will follow a similar strategy using generalized mixed effects models for repeat measurements, using a link function appropriate for each outcome. All analyses will be conducted under the quality system of the HRB CRF-UCC. A statistical analysis plan is available on the Open Science Framework ( https://osf.io/ns7u5/ ). Any necessary deviations from this SAP will be documented and explained in the trial report. All reporting will carried out in accordance with CONSORT guidelines for clinical trials. Data monitoring As this is a low risk trial (of a complex intervention), the Steering Committee will also act as the Independent Data Monitoring Committee (IDMC). They will monitor the safety of participants and make recommendations to the management group in relation to ethical issues and maintaining the integrity of the trial. To ensure protocols in relation to governance and safety monitoring are strictly adhered to, the steering committee includes personnel who can monitor and give expert advice that is completely independent of the PI; the trial managers; the research team members; and the institutions involved. More details regarding steering committee membership are provided in the supplemental material. Because data collection will take place over two cycles, we will have an opportunity to conduct an interim analysis at the end of the data collection completed for the first cycle. At this stage, we will know if the cycle 1 recruitment targets were met, and also be able to estimate the degree of clustering and variance we observed for the outcomes. This information will in turn facilitate a sample size re-evaluation that can inform how the study proceeds for the second cycle. If the re-analysis suggests that an increased sample size target is required for cycle two, this will be carefully considered by the Trial Steering Committee (if no such increase is suggested, then the study will proceed as planned). At this stage, the Trial Steering Committee will have the option of requesting a formal futility analysis to help determine whether the trial should continue or be stopped prior to data collection in year two. Details of the analysis and the results of the Trial Steering Committees’ deliberations will be reported back to the funder and a final decision will be negotiated by all stakeholders. Economic evaluation Although the economic benefits of investing in early intervention for children are well established ( Heckman, 2006 ), and cost effectiveness has been examined in relation to education and health programmes with broad outcomes (e.g. Knight et al. , 2019 ; Ludwig & Phillips, 2008 ), limited work has been done modelling the immediate or long term economic benefits of speech and language interventions ( Le et al. , 2020 ). An economic evaluation will compare the costs and effects of the Happy Talk intervention, to usual care. The evaluation will also include a budget impact analysis, which predicts the potential financial impact of the adoption and diffusion of Happy Talk, to inform resource or budget planning. The evaluation builds on a previous economic evaluation of our small-scale effectiveness trial ( Frizelle et al. , 2021a ). The preliminary economic evaluation included a value of information analysis that suggested there was value in collecting further information. This scaled up, full definitive trial will a) provide updated parameter estimates on costs and effectiveness; b) reduce uncertainties around parameter estimates and c) reduce uncertainty around cost effectiveness estimates. Following standard Health Information and Quality Authority (HIQA) guidelines on conducting economic evaluations a cost utility analysis will be undertaken. In the baseline analysis the perspective of the service provider will be adopted, thus only direct resources utilised will be included. All resources utilised for the delivery of the intervention and standard care will be identified, measured and valued using micro-costing techniques. Resources utilised will be captured by a dedicated resource utilisation questionnaire. The evaluation will include a primary, secondary and sensitivity analyses. In our primary cost utility analysis effectiveness will be measured using standardised Health Related Quality of Life (HRQoL) questionnaires pre-, post- and at 12 months follow-up. HRQoL measures enable the calculation of Quality Adjusted Life Years (QALYs) as well as an investigation of the sensitivity of these measures with children. To date the use of child appropriate HRQOL is limited, with many studies employing measures and health state values intended for adults. In addition, no health technology assessment (HTA) agency worldwide provides methods guidance on measuring HRQoL in young people. Given persistent issues with valuing child HRQoL, including expected delayed differences in HRQoL and lack of value sets, clinical measures (The PLS-5 and the Focus-34) will be used to test the robustness of results in our secondary analysis. Lastly, the sensitivity analysis will assesses robustness of the effectiveness measures, uncertainty in input and resulting output parameters. Analysis: Difference in costs and effects between the intervention and standard care will be estimated and an Incremental Cost Effectiveness Ratio (ICER) will be estimated. For the baseline analysis if this ICER is less than the nationally accepted threshold (€45,000/QALY) the intervention could be considered cost effective compared to standard care. Results of the probabilistic sensitivity analysis will be presented on Incremental Cost Effectiveness Planes and Cost Effectiveness Acceptability Curves to investigate uncertainty surrounding the output parameters and cost effectiveness decision. The cost results in the economic evaluation will inform the Budget Impact Analysis which will examine budgetary implications associated with national scaling up the intervention over a 5-year period (as per HIQA guidelines). Discussion The Happy Talk trial aims to mitigate the effects of social disadvantage on child language outcomes and therefore improve the overall life chances of children living in deprivation. The programme is already well established in one region of Ireland and has been shown to be both feasible and acceptable to parents, early years educators and speech and language therapists. The trial is a large scale ‘real world’ effectiveness trial, embedded in the community, which engages with parents and educators, and as such responds to identified evidence gaps. The trial includes an at scale economic evaluation from the perspective of the healthcare provider and outcomes address both functional and standardized measures. If effective we anticipate the following outcomes: Evidence that receptive and expressive language difficulties and their functional manifestation can be improved in pre- and early school years, in a cost effective manner, using a public health service delivery model. The availability of a well evaluated speech, language and communication intervention which can be implemented by speech and language therapists in the community, Ethics and consent The study has been reviewed and approved by the Reference Research Ethics committee, Health Services Executive, Dublin and Midlands (with remit for National approval) – RRECB0124PF (14 th March, 2024). Any changes to the protocol will be submitted as an amendment to the original submission. To obtain informed consent, each SLT, educational setting (preschool manager/school principal), educator, parent/ caregiver and child will be provided with an information letter and consent/assent form, adapted to their specific group. Participation in the study and the identity of the participants will be treated as confidential and no participant identifiable records or results relating to the study will be disclosed to any third party other than the authorized investigators. However, if children are identified as having significant speech and language difficulties that require individual intervention, families will be supported by their interventionist for onward referral. Personal identifiers will undergo pseudonymization. An encryption key, held securely away from the data, will be accessible to the project PI at site only. In line with the funders (Health Research Board) policy for post-project data publication, consent will be obtained at recruitment for all anonymized data to be shared publicly on an open science repository. Careful evaluation and assessment of publishable data catalogues will be continually reviewed to ensure that data objects will be ‘as open as possible, yet as closed as necessary’ upon completion of the research. The use of data repositories will ensure maximum utility and interoperability of the final data package(s) and assignment of a persistent digital object identifier (DOI). Additional post-study data provenance will be enacted through sharing of analysis scripts and study protocols via the Open Science Framework and/or the HRB Open Research platform projects with accompanying DOI(s). Study findings will be written up as journal publications, and published open access. Findings will also be disseminated to our participants through lay summaries on the project website and will presented to the CHO policy makers at a national meeting. Project co-applicants and collaborators will be eligible for authorship. Data availability No new data are associated with this article. Extended data: Extended data are available on the Open Science Framework. Evaluating a targeted selective speech, language, and communication intervention at scale – the Happy Talk cluster randomised controlled trial (DOI 10.17605/OSF.IO/NS7U5 ) ( Frizelle et al. , 2024 ) The project contains the following underlying data. 1. Child Participant Trial and Process Evaluation information leaflet 2. Parent Caregiver Participant Trial and Process Evaluation Consent form 3. Parent Caregiver Participant Trial and Process Evaluation information leaflet 4. Educator Participant Trial and Process Evaluation information leaflet 5. SLT and Educator Participant Trial and Process Evaluation consent form 6. Resource Utilisation Questionnaire 7. Statistical Analysis plan 8. SPIRIT Checklist 9. Trial Governance 10. WHO Trial Registration Dataset Data are available under a CCO license. Faculty Opinions recommended References Althouse AD: Adjust for multiple comparisons? It’s not that simple. 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Comments on this article Comments (0) Version 3 VERSION 3 PUBLISHED 08 Oct 2024 ADD YOUR COMMENT Comment Author details Author details 1 Department of Speech and Hearing Sciences, School of Clinical Therapies, University College Cork, Cork, Ireland 2 Speech and Language Therapy Department, Health Services Executive, Cork, Ireland 3 Department of Economics, University College Cork, Cork, Ireland 4 School of Public Health, University College Cork, Cork, Ireland 5 Department of Education, Oxford University, Oxford, UK Pauline Frizelle Roles: Conceptualization, Funding Acquisition, Project Administration, Writing – Original Draft Preparation Aoife O'Shea Roles: Investigation, Project Administration Aileen Murphy Roles: Formal Analysis, Methodology, Visualization, Writing – Review & Editing Darren Dahly Roles: Data Curation, Formal Analysis, Methodology, Visualization, Writing – Review & Editing Cristina McKean Roles: Conceptualization, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information Health Research Board Ireland [DIFA 2023 001]. This work was also supported by the Irish Health Services Executive. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Article Versions (3) version 3 Revised Published: 31 Jan 2025, 7:65 https://doi.org/10.12688/hrbopenres.13973.3 version 2 Revised Published: 07 Dec 2024, 7:65 https://doi.org/10.12688/hrbopenres.13973.2 version 1 Published: 08 Oct 2024, 7:65 https://doi.org/10.12688/hrbopenres.13973.1 Copyright © 2025 Frizelle P et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics VIEWS $counts.viewCount downloads Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Frizelle P, O'Shea A, Murphy A et al. Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.12688/hrbopenres.13973.3 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 3 VERSION 3 PUBLISHED 31 Jan 2025 Revised Views 0 Cite How to cite this report: Ramirez NF and Braverman A. Reviewer Report For: Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.21956/hrbopenres.15461.r45226 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-65/v3#referee-response-45226 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 04 Feb 2025 Naja Ferjan Ramirez , University of Washington, Seattle, USA Adeline Braverman , University of Washington Seattle, USA, USA; Linguistics, University of Washington (Ringgold ID: 7284), Seattle, Washington, USA Approved VIEWS 0 https://doi.org/10.21956/hrbopenres.15461.r45226 I think the authors ... Continue reading READ ALL I think the authors have adequately addressed our concerns/questions. Competing Interests: No competing interests were disclosed. Reviewer Expertise: Language acquisition in infancy and early childhood; Language intervention; Language input We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Ramirez NF and Braverman A. Reviewer Report For: Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.21956/hrbopenres.15461.r45226 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-65/v3#referee-response-45226 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Botting N. Reviewer Report For: Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.21956/hrbopenres.15461.r45223 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-65/v3#referee-response-45223 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 04 Feb 2025 Nicola Botting , City University London, London, UK Approved VIEWS 0 https://doi.org/10.21956/hrbopenres.15461.r45223 Thank you for detailed responses to my ... Continue reading READ ALL Thank you for detailed responses to my comments. I am happy to approve version 3. Competing Interests: No competing interests were disclosed. Reviewer Expertise: Developmental Language Disorder & other forms of atypical language development I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Botting N. Reviewer Report For: Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.21956/hrbopenres.15461.r45223 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-65/v3#referee-response-45223 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Version 2 VERSION 2 PUBLISHED 07 Dec 2024 Revised Views 0 Cite How to cite this report: Ramirez NF and Braverman A. Reviewer Report For: Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.21956/hrbopenres.15422.r44222 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-65/v2#referee-response-44222 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 11 Jan 2025 Naja Ferjan Ramirez , University of Washington, Seattle, USA Adeline Braverman , University of Washington Seattle, USA, USA; Linguistics, University of Washington (Ringgold ID: 7284), Seattle, Washington, USA Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15422.r44222 This is a revised version of the narrative, and I think most of the issues have already been addressed. Overall, the study is well-designed and targets an important public health concern. We are pointing out some potential areas of improvement. ... Continue reading READ ALL This is a revised version of the narrative, and I think most of the issues have already been addressed. Overall, the study is well-designed and targets an important public health concern. We are pointing out some potential areas of improvement. 12 1-hr sessions attended by parents: This could be a challenge as it is quite intensive and requires a lot of time and effort. Parents are busy, and may not be able to attend all (or even most) sessions – this seems especially relevant given that families are low SES. How will the team make sure that parents attend the sessions? The narrative suggests that this intervention has already been implemented successfully in parts of Ireland. Is there any data to show that parents stayed engaged throughout the program? On a related note, were parents invited to help in the DESIGN of the intervention? Do we know that they find it (culturally) acceptable and doable/executable given their day-to-day lives? Not much is said about this in the narrative. The second research question asks whether Happy Talk “enhance[s] responsiveness and language-promoting behaviors in home and pre/school contexts.” The associated hypothesis is that intervention parents will have higher Maternal Responsive Behaviors Coding Scheme (MRBCS) scores. Is the MRBCS sensitive to “language-promoting behaviors” beyond those associated with responsiveness? The research question may need to be narrowed so that it is adequately addressed by this outcome measure, or the authors should clarify that responsiveness is the language-promoting behavior in question. Nothing is said about measuring “attendance” – i.e. are the effects of the intervention hypothesized to be weaker in those families who attend fewer sessions? Relatedly, what were the attendance/drop-out rates in previous iterations of the intervention? Inclusion of fathers: not much is said about this…in our experience, if fathers are just “invited”, they tend to not attend the sessions. Will there be an explicit effort to recruit and retain the fathers? Why (not)? OR – alternatively - if both parents attend in some cases, and only one parent attend in others, can there be supplemental hypotheses around whether one or both parents received the treatment? In the ‘Data Collection’ section, it is somewhat unclear what measures will be collected at the Baseline Assessment. Are all outcome measures included at this initial timepoint? How will the PLS-5 be scored by the second research assistant? Will these assessments be recorded? Preschool staff treatment – 4x 2.5-3 hours of staff training: similarly to parent training, do we know that the staff are eager and excited to undergo these trainings? What about the school administration? Will they be able to pull the teachers out of the classroom to give them the necessary time for training? On a related note, are teachers engaged in the design of the intervention? If so, what are their opinions of it? If not, they may find it challenging to implement. Child outcomes: most are parent/staff reports, which is a disadvantage, given that they’re being treated. One might hypothesize that the intervention will train the parents/staff to answer the questionnaires differently compared to the control group. I recommend that the team add child outcome language measures that are NOT questionnaire based. This was already noted by a previous reviewer. In their response, the authors cite work demonstrating the reliability and validity of parent report instruments, but this work focuses only on the MBCDI in a younger age range than the proposed sample and outside the context of parent-mediated intervention. In Figure 2, the use of multiple arrows leads the reader to believe that each bullet point is associated with another in the neighboring box. However, the bullet points do not always line up (in number and content). Consider reducing the number of arrows or clarifying the connections between the contents of each box. For the most part, there is sufficient detail of the methods provided to allow for replication. The hypotheses and the rationale, the subject numbers and characteristics are well described and make sense. The only thing that’s missing is the intervention “scripts”/ content/ manual – this is not shared, so one could not actually replicate the study as it is unclear what the parents / staff are actually told during the sessions. I am not sure if this is intentional. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Language acquisition in infancy and early childhood; Language intervention; Language input We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however we have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Ramirez NF and Braverman A. Reviewer Report For: Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.21956/hrbopenres.15422.r44222 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-65/v2#referee-response-44222 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 24 Jan 2025 Pauline Frizelle , Department of Speech and Hearing Sciences, School of Clinical Therapies, University College Cork, Cork, Ireland 24 Jan 2025 Author Response Many thanks for your valuable feedback, we have addressed each point in turn. 12 1-hr sessions attended by parents: This could be a challenge as it is quite intensive ... Continue reading Many thanks for your valuable feedback, we have addressed each point in turn. 12 1-hr sessions attended by parents: This could be a challenge as it is quite intensive and requires a lot of time and effort. Parents are busy, and may not be able to attend all (or even most) sessions – this seems especially relevant given that families are low SES. How will the team make sure that parents attend the sessions? The narrative suggests that this intervention has already been implemented successfully in parts of Ireland. Is there any data to show that parents stayed engaged throughout the program? On a related note, were parents invited to help in the DESIGN of the intervention? Do we know that they find it (culturally) acceptable and doable/executable given their day-to-day lives? Not much is said about this in the narrative. Response: Happy Talk has been delivered in one part of Ireland for 12 years. The programme was originally developed by SLTs but the design has been adapted over the years based on feedback from parents and early years educators. We also measured feasibility and acceptability in a new area in our pilot trial (referenced within). As stated in response to reviewer 2, in areas where Happy Talk is well established there is very high attendance as other parents/educators have spoken so positively about the programme and parents have an expectation that this will be part of their child’s education. In new areas (as is the case here) attendance tends to increase as the programme progresses. Parents become more committed as their confidence increases, and children request their parents to be present in the classroom, as they enjoy this aspect of the programme. In any case, we take a conservative approach in using an intention to treat protocol, so that if a parent attends even one session they are considered to have received the intervention. The second research question asks whether Happy Talk “enhance[s] responsiveness and language-promoting behaviors in home and pre/school contexts.” The associated hypothesis is that intervention parents will have higher Maternal Responsive Behaviors Coding Scheme (MRBCS) scores. Is the MRBCS sensitive to “language-promoting behaviors” beyond those associated with responsiveness? The research question may need to be narrowed so that it is adequately addressed by this outcome measure, or the authors should clarify that responsiveness is the language-promoting behavior in question. Response: We have clarified that responsiveness is the language-promoting behavior in question. Nothing is said about measuring “attendance” – i.e. are the effects of the intervention hypothesized to be weaker in those families who attend fewer sessions? Relatedly, what were the attendance/drop-out rates in previous iterations of the intervention? Response: We have clarified that attendance will be measured throughout both iterations of the programme. As stated above, attendance tends to increase as parents become more engaged with the programme. We have reported the attendance rates and attrition in our published pilot trial. Inclusion of fathers: not much is said about this…in our experience, if fathers are just “invited”, they tend to not attend the sessions. Will there be an explicit effort to recruit and retain the fathers? Why (not)? OR – alternatively - if both parents attend in some cases, and only one parent attend in others, can there be supplemental hypotheses around whether one or both parents received the treatment? Response: Given the demands of the programme the reviewer has highlighted, we encourage one parent/caregiver to attend, whichever places the smallest burden on the family. In our experience this is most often the mother but fathers and grandparents have also attended. If there are a sufficient number of cases where individual parents attend different sessions or both parents attend we will examine any potential effects statistically. However, this has not been our experience in the past. We request that the same person attend for baseline and end of programme measures. In the ‘Data Collection’ section, it is somewhat unclear what measures will be collected at the Baseline Assessment. Are all outcome measures included at this initial timepoint? Response : We have clarified that all outcome measures are included at the initial stages. How will the PLS-5 be scored by the second research assistant? Will these assessments be recorded? Response: No, these are not recorded. The 2 nd researcher will check that the scores have been added correctly, and converted accurately into standard scores. We have clarified this in the text. Preschool staff treatment – 4x 2.5-3 hours of staff training: similarly to parent training, do we know that the staff are eager and excited to undergo these trainings? What about the school administration? Will they be able to pull the teachers out of the classroom to give them the necessary time for training? On a related note, are teachers engaged in the design of the intervention? If so, what are their opinions of it? If not, they may find it challenging to implement. Response : In keeping with my response with respect to parents, teachers have implemented the programme in one area of Ireland for many years, and have reported it to be feasible and acceptable – we have noted this in the text. They have also had input into the programme as it was developing over many years. We carry out the sessions in the classroom at a time that is convenient for the teachers. In addition, all teachers are required to engage with continuous professional development, the Happy Talk training fulfils that need. Child outcomes: most are parent/staff reports, which is a disadvantage, given that they’re being treated. One might hypothesize that the intervention will train the parents/staff to answer the questionnaires differently compared to the control group. I recommend that the team add child outcome language measures that are NOT questionnaire based. This was already noted by a previous reviewer. In their response, the authors cite work demonstrating the reliability and validity of parent report instruments, but this work focuses only on the MBCDI in a younger age range than the proposed sample and outside the context of parent-mediated intervention. Response : We have included the PLS-5 which is a standardized language measure which provides a receptive, expressive and composite language score. In Figure 2, the use of multiple arrows leads the reader to believe that each bullet point is associated with another in the neighboring box. However, the bullet points do not always line up (in number and content). Consider reducing the number of arrows or clarifying the connections between the contents of each box. Response: Where arrows don’t directly align they are intended to refer to more than one component within a given box, we have clarified this in the text. For the most part, there is sufficient detail of the methods provided to allow for replication. The hypotheses and the rationale, the subject numbers and characteristics are well described and make sense. The only thing that’s missing is the intervention “scripts”/ content/ manual – this is not shared, so one could not actually replicate the study as it is unclear what the parents / staff are actually told during the sessions. I am not sure if this is intentional. Response: We cannot make the manual publicly available due to copyright reasons. Those who are interested in getting further information, or adapting the intervention to their context are welcome to get in touch with the first author. Many thanks for your valuable feedback, we have addressed each point in turn. 12 1-hr sessions attended by parents: This could be a challenge as it is quite intensive and requires a lot of time and effort. Parents are busy, and may not be able to attend all (or even most) sessions – this seems especially relevant given that families are low SES. How will the team make sure that parents attend the sessions? The narrative suggests that this intervention has already been implemented successfully in parts of Ireland. Is there any data to show that parents stayed engaged throughout the program? On a related note, were parents invited to help in the DESIGN of the intervention? Do we know that they find it (culturally) acceptable and doable/executable given their day-to-day lives? Not much is said about this in the narrative. Response: Happy Talk has been delivered in one part of Ireland for 12 years. The programme was originally developed by SLTs but the design has been adapted over the years based on feedback from parents and early years educators. We also measured feasibility and acceptability in a new area in our pilot trial (referenced within). As stated in response to reviewer 2, in areas where Happy Talk is well established there is very high attendance as other parents/educators have spoken so positively about the programme and parents have an expectation that this will be part of their child’s education. In new areas (as is the case here) attendance tends to increase as the programme progresses. Parents become more committed as their confidence increases, and children request their parents to be present in the classroom, as they enjoy this aspect of the programme. In any case, we take a conservative approach in using an intention to treat protocol, so that if a parent attends even one session they are considered to have received the intervention. The second research question asks whether Happy Talk “enhance[s] responsiveness and language-promoting behaviors in home and pre/school contexts.” The associated hypothesis is that intervention parents will have higher Maternal Responsive Behaviors Coding Scheme (MRBCS) scores. Is the MRBCS sensitive to “language-promoting behaviors” beyond those associated with responsiveness? The research question may need to be narrowed so that it is adequately addressed by this outcome measure, or the authors should clarify that responsiveness is the language-promoting behavior in question. Response: We have clarified that responsiveness is the language-promoting behavior in question. Nothing is said about measuring “attendance” – i.e. are the effects of the intervention hypothesized to be weaker in those families who attend fewer sessions? Relatedly, what were the attendance/drop-out rates in previous iterations of the intervention? Response: We have clarified that attendance will be measured throughout both iterations of the programme. As stated above, attendance tends to increase as parents become more engaged with the programme. We have reported the attendance rates and attrition in our published pilot trial. Inclusion of fathers: not much is said about this…in our experience, if fathers are just “invited”, they tend to not attend the sessions. Will there be an explicit effort to recruit and retain the fathers? Why (not)? OR – alternatively - if both parents attend in some cases, and only one parent attend in others, can there be supplemental hypotheses around whether one or both parents received the treatment? Response: Given the demands of the programme the reviewer has highlighted, we encourage one parent/caregiver to attend, whichever places the smallest burden on the family. In our experience this is most often the mother but fathers and grandparents have also attended. If there are a sufficient number of cases where individual parents attend different sessions or both parents attend we will examine any potential effects statistically. However, this has not been our experience in the past. We request that the same person attend for baseline and end of programme measures. In the ‘Data Collection’ section, it is somewhat unclear what measures will be collected at the Baseline Assessment. Are all outcome measures included at this initial timepoint? Response : We have clarified that all outcome measures are included at the initial stages. How will the PLS-5 be scored by the second research assistant? Will these assessments be recorded? Response: No, these are not recorded. The 2 nd researcher will check that the scores have been added correctly, and converted accurately into standard scores. We have clarified this in the text. Preschool staff treatment – 4x 2.5-3 hours of staff training: similarly to parent training, do we know that the staff are eager and excited to undergo these trainings? What about the school administration? Will they be able to pull the teachers out of the classroom to give them the necessary time for training? On a related note, are teachers engaged in the design of the intervention? If so, what are their opinions of it? If not, they may find it challenging to implement. Response : In keeping with my response with respect to parents, teachers have implemented the programme in one area of Ireland for many years, and have reported it to be feasible and acceptable – we have noted this in the text. They have also had input into the programme as it was developing over many years. We carry out the sessions in the classroom at a time that is convenient for the teachers. In addition, all teachers are required to engage with continuous professional development, the Happy Talk training fulfils that need. Child outcomes: most are parent/staff reports, which is a disadvantage, given that they’re being treated. One might hypothesize that the intervention will train the parents/staff to answer the questionnaires differently compared to the control group. I recommend that the team add child outcome language measures that are NOT questionnaire based. This was already noted by a previous reviewer. In their response, the authors cite work demonstrating the reliability and validity of parent report instruments, but this work focuses only on the MBCDI in a younger age range than the proposed sample and outside the context of parent-mediated intervention. Response : We have included the PLS-5 which is a standardized language measure which provides a receptive, expressive and composite language score. In Figure 2, the use of multiple arrows leads the reader to believe that each bullet point is associated with another in the neighboring box. However, the bullet points do not always line up (in number and content). Consider reducing the number of arrows or clarifying the connections between the contents of each box. Response: Where arrows don’t directly align they are intended to refer to more than one component within a given box, we have clarified this in the text. For the most part, there is sufficient detail of the methods provided to allow for replication. The hypotheses and the rationale, the subject numbers and characteristics are well described and make sense. The only thing that’s missing is the intervention “scripts”/ content/ manual – this is not shared, so one could not actually replicate the study as it is unclear what the parents / staff are actually told during the sessions. I am not sure if this is intentional. Response: We cannot make the manual publicly available due to copyright reasons. Those who are interested in getting further information, or adapting the intervention to their context are welcome to get in touch with the first author. Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 24 Jan 2025 Pauline Frizelle , Department of Speech and Hearing Sciences, School of Clinical Therapies, University College Cork, Cork, Ireland 24 Jan 2025 Author Response Many thanks for your valuable feedback, we have addressed each point in turn. 12 1-hr sessions attended by parents: This could be a challenge as it is quite intensive ... Continue reading Many thanks for your valuable feedback, we have addressed each point in turn. 12 1-hr sessions attended by parents: This could be a challenge as it is quite intensive and requires a lot of time and effort. Parents are busy, and may not be able to attend all (or even most) sessions – this seems especially relevant given that families are low SES. How will the team make sure that parents attend the sessions? The narrative suggests that this intervention has already been implemented successfully in parts of Ireland. Is there any data to show that parents stayed engaged throughout the program? On a related note, were parents invited to help in the DESIGN of the intervention? Do we know that they find it (culturally) acceptable and doable/executable given their day-to-day lives? Not much is said about this in the narrative. Response: Happy Talk has been delivered in one part of Ireland for 12 years. The programme was originally developed by SLTs but the design has been adapted over the years based on feedback from parents and early years educators. We also measured feasibility and acceptability in a new area in our pilot trial (referenced within). As stated in response to reviewer 2, in areas where Happy Talk is well established there is very high attendance as other parents/educators have spoken so positively about the programme and parents have an expectation that this will be part of their child’s education. In new areas (as is the case here) attendance tends to increase as the programme progresses. Parents become more committed as their confidence increases, and children request their parents to be present in the classroom, as they enjoy this aspect of the programme. In any case, we take a conservative approach in using an intention to treat protocol, so that if a parent attends even one session they are considered to have received the intervention. The second research question asks whether Happy Talk “enhance[s] responsiveness and language-promoting behaviors in home and pre/school contexts.” The associated hypothesis is that intervention parents will have higher Maternal Responsive Behaviors Coding Scheme (MRBCS) scores. Is the MRBCS sensitive to “language-promoting behaviors” beyond those associated with responsiveness? The research question may need to be narrowed so that it is adequately addressed by this outcome measure, or the authors should clarify that responsiveness is the language-promoting behavior in question. Response: We have clarified that responsiveness is the language-promoting behavior in question. Nothing is said about measuring “attendance” – i.e. are the effects of the intervention hypothesized to be weaker in those families who attend fewer sessions? Relatedly, what were the attendance/drop-out rates in previous iterations of the intervention? Response: We have clarified that attendance will be measured throughout both iterations of the programme. As stated above, attendance tends to increase as parents become more engaged with the programme. We have reported the attendance rates and attrition in our published pilot trial. Inclusion of fathers: not much is said about this…in our experience, if fathers are just “invited”, they tend to not attend the sessions. Will there be an explicit effort to recruit and retain the fathers? Why (not)? OR – alternatively - if both parents attend in some cases, and only one parent attend in others, can there be supplemental hypotheses around whether one or both parents received the treatment? Response: Given the demands of the programme the reviewer has highlighted, we encourage one parent/caregiver to attend, whichever places the smallest burden on the family. In our experience this is most often the mother but fathers and grandparents have also attended. If there are a sufficient number of cases where individual parents attend different sessions or both parents attend we will examine any potential effects statistically. However, this has not been our experience in the past. We request that the same person attend for baseline and end of programme measures. In the ‘Data Collection’ section, it is somewhat unclear what measures will be collected at the Baseline Assessment. Are all outcome measures included at this initial timepoint? Response : We have clarified that all outcome measures are included at the initial stages. How will the PLS-5 be scored by the second research assistant? Will these assessments be recorded? Response: No, these are not recorded. The 2 nd researcher will check that the scores have been added correctly, and converted accurately into standard scores. We have clarified this in the text. Preschool staff treatment – 4x 2.5-3 hours of staff training: similarly to parent training, do we know that the staff are eager and excited to undergo these trainings? What about the school administration? Will they be able to pull the teachers out of the classroom to give them the necessary time for training? On a related note, are teachers engaged in the design of the intervention? If so, what are their opinions of it? If not, they may find it challenging to implement. Response : In keeping with my response with respect to parents, teachers have implemented the programme in one area of Ireland for many years, and have reported it to be feasible and acceptable – we have noted this in the text. They have also had input into the programme as it was developing over many years. We carry out the sessions in the classroom at a time that is convenient for the teachers. In addition, all teachers are required to engage with continuous professional development, the Happy Talk training fulfils that need. Child outcomes: most are parent/staff reports, which is a disadvantage, given that they’re being treated. One might hypothesize that the intervention will train the parents/staff to answer the questionnaires differently compared to the control group. I recommend that the team add child outcome language measures that are NOT questionnaire based. This was already noted by a previous reviewer. In their response, the authors cite work demonstrating the reliability and validity of parent report instruments, but this work focuses only on the MBCDI in a younger age range than the proposed sample and outside the context of parent-mediated intervention. Response : We have included the PLS-5 which is a standardized language measure which provides a receptive, expressive and composite language score. In Figure 2, the use of multiple arrows leads the reader to believe that each bullet point is associated with another in the neighboring box. However, the bullet points do not always line up (in number and content). Consider reducing the number of arrows or clarifying the connections between the contents of each box. Response: Where arrows don’t directly align they are intended to refer to more than one component within a given box, we have clarified this in the text. For the most part, there is sufficient detail of the methods provided to allow for replication. The hypotheses and the rationale, the subject numbers and characteristics are well described and make sense. The only thing that’s missing is the intervention “scripts”/ content/ manual – this is not shared, so one could not actually replicate the study as it is unclear what the parents / staff are actually told during the sessions. I am not sure if this is intentional. Response: We cannot make the manual publicly available due to copyright reasons. Those who are interested in getting further information, or adapting the intervention to their context are welcome to get in touch with the first author. Many thanks for your valuable feedback, we have addressed each point in turn. 12 1-hr sessions attended by parents: This could be a challenge as it is quite intensive and requires a lot of time and effort. Parents are busy, and may not be able to attend all (or even most) sessions – this seems especially relevant given that families are low SES. How will the team make sure that parents attend the sessions? The narrative suggests that this intervention has already been implemented successfully in parts of Ireland. Is there any data to show that parents stayed engaged throughout the program? On a related note, were parents invited to help in the DESIGN of the intervention? Do we know that they find it (culturally) acceptable and doable/executable given their day-to-day lives? Not much is said about this in the narrative. Response: Happy Talk has been delivered in one part of Ireland for 12 years. The programme was originally developed by SLTs but the design has been adapted over the years based on feedback from parents and early years educators. We also measured feasibility and acceptability in a new area in our pilot trial (referenced within). As stated in response to reviewer 2, in areas where Happy Talk is well established there is very high attendance as other parents/educators have spoken so positively about the programme and parents have an expectation that this will be part of their child’s education. In new areas (as is the case here) attendance tends to increase as the programme progresses. Parents become more committed as their confidence increases, and children request their parents to be present in the classroom, as they enjoy this aspect of the programme. In any case, we take a conservative approach in using an intention to treat protocol, so that if a parent attends even one session they are considered to have received the intervention. The second research question asks whether Happy Talk “enhance[s] responsiveness and language-promoting behaviors in home and pre/school contexts.” The associated hypothesis is that intervention parents will have higher Maternal Responsive Behaviors Coding Scheme (MRBCS) scores. Is the MRBCS sensitive to “language-promoting behaviors” beyond those associated with responsiveness? The research question may need to be narrowed so that it is adequately addressed by this outcome measure, or the authors should clarify that responsiveness is the language-promoting behavior in question. Response: We have clarified that responsiveness is the language-promoting behavior in question. Nothing is said about measuring “attendance” – i.e. are the effects of the intervention hypothesized to be weaker in those families who attend fewer sessions? Relatedly, what were the attendance/drop-out rates in previous iterations of the intervention? Response: We have clarified that attendance will be measured throughout both iterations of the programme. As stated above, attendance tends to increase as parents become more engaged with the programme. We have reported the attendance rates and attrition in our published pilot trial. Inclusion of fathers: not much is said about this…in our experience, if fathers are just “invited”, they tend to not attend the sessions. Will there be an explicit effort to recruit and retain the fathers? Why (not)? OR – alternatively - if both parents attend in some cases, and only one parent attend in others, can there be supplemental hypotheses around whether one or both parents received the treatment? Response: Given the demands of the programme the reviewer has highlighted, we encourage one parent/caregiver to attend, whichever places the smallest burden on the family. In our experience this is most often the mother but fathers and grandparents have also attended. If there are a sufficient number of cases where individual parents attend different sessions or both parents attend we will examine any potential effects statistically. However, this has not been our experience in the past. We request that the same person attend for baseline and end of programme measures. In the ‘Data Collection’ section, it is somewhat unclear what measures will be collected at the Baseline Assessment. Are all outcome measures included at this initial timepoint? Response : We have clarified that all outcome measures are included at the initial stages. How will the PLS-5 be scored by the second research assistant? Will these assessments be recorded? Response: No, these are not recorded. The 2 nd researcher will check that the scores have been added correctly, and converted accurately into standard scores. We have clarified this in the text. Preschool staff treatment – 4x 2.5-3 hours of staff training: similarly to parent training, do we know that the staff are eager and excited to undergo these trainings? What about the school administration? Will they be able to pull the teachers out of the classroom to give them the necessary time for training? On a related note, are teachers engaged in the design of the intervention? If so, what are their opinions of it? If not, they may find it challenging to implement. Response : In keeping with my response with respect to parents, teachers have implemented the programme in one area of Ireland for many years, and have reported it to be feasible and acceptable – we have noted this in the text. They have also had input into the programme as it was developing over many years. We carry out the sessions in the classroom at a time that is convenient for the teachers. In addition, all teachers are required to engage with continuous professional development, the Happy Talk training fulfils that need. Child outcomes: most are parent/staff reports, which is a disadvantage, given that they’re being treated. One might hypothesize that the intervention will train the parents/staff to answer the questionnaires differently compared to the control group. I recommend that the team add child outcome language measures that are NOT questionnaire based. This was already noted by a previous reviewer. In their response, the authors cite work demonstrating the reliability and validity of parent report instruments, but this work focuses only on the MBCDI in a younger age range than the proposed sample and outside the context of parent-mediated intervention. Response : We have included the PLS-5 which is a standardized language measure which provides a receptive, expressive and composite language score. In Figure 2, the use of multiple arrows leads the reader to believe that each bullet point is associated with another in the neighboring box. However, the bullet points do not always line up (in number and content). Consider reducing the number of arrows or clarifying the connections between the contents of each box. Response: Where arrows don’t directly align they are intended to refer to more than one component within a given box, we have clarified this in the text. For the most part, there is sufficient detail of the methods provided to allow for replication. The hypotheses and the rationale, the subject numbers and characteristics are well described and make sense. The only thing that’s missing is the intervention “scripts”/ content/ manual – this is not shared, so one could not actually replicate the study as it is unclear what the parents / staff are actually told during the sessions. I am not sure if this is intentional. Response: We cannot make the manual publicly available due to copyright reasons. Those who are interested in getting further information, or adapting the intervention to their context are welcome to get in touch with the first author. Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Botting N. Reviewer Report For: Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.21956/hrbopenres.15422.r43956 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-65/v2#referee-response-43956 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 08 Jan 2025 Nicola Botting , City University London, London, UK Approved VIEWS 0 https://doi.org/10.21956/hrbopenres.15422.r43956 This is a very well constructed and clear protocol for a large scale intervention trial using the Happy Talk programme. There is substantial need for the evaluation of early years language interventions such as this, and this team is ideally ... Continue reading READ ALL This is a very well constructed and clear protocol for a large scale intervention trial using the Happy Talk programme. There is substantial need for the evaluation of early years language interventions such as this, and this team is ideally placed to carry out such research. The previous 2 reviewers have given comprehensive and insightful comments, many of which have already been responded to by the authors, therefore my observations are brief and minor. Some of them echo other points already made. 1. RQ1: It might be helpful for readers to include 'compared to usual care' in RQ1. This is implied, but at the moment leaves the possibility that positive within-group change for the intervention group alone could answer this question (which is not the authors' intention). 2. Recruitment: Opt-in consent is being used. It would be useful to identify and detail any strategies for monitoring/ensuring that these sign ups represent low SES groups, as even within schools in disadvantaged areas, participation from some groups is difficult to attain. Would opt-out consent be considered if recruitment shows bias? Have the authors considered adding the option for a Qualtrics (or similar) link to consent, which we are finding useful in recruiting families where bits of paper get lost (I acknowledge this method has its own inherent biases, but maybe a combination?). Under Randomisation, it could be made clearer that the families are randomly selected *from consenting families*. The inclusion of families with additional languages is important, but it is not clear to me how the parent English level will be assessed. A small point but it is probably best to avoid the term 'subjects' even in a trial? 3. Data management: I have no doubt that this team are thoroughly conversant in data management, but for readers and replicability more detail about how data sharing (agreements), and transit across sites (and countries) will be securely achieved would be welcome. It would be useful to know who has overall responsibility for data governance and data backups etc. 4. Training workshops: It was not clear to me how many people are at each workshop or included in the weekly video-conference support sessions. This detail seems important in terms of attendance bias, and success of the programme, and is needed for replicability. It would be useful to specify whether by 'recorded' you mean video or audio only. How will you deal with participants who do not give consent to recording or to other people in the background? 5. Assessment measures: In line with the other reviews, I am not sure about the CLASS and wondered whether authors had considered the CsC developed by Dockrell et al. for Better Communication? Will the reliability measures taken by an additional person occur at the same time or on a different day? In addition I wondered whether the FOCUS-34 has a reference? A couple of example questions might be useful here. For the MRBCS, I think this should read 'a total number of occurrences for each of four parental behaviours'? If not, more explanation is needed. 6. Economic assessment: I agree with other reviewers that it is confusing to use only the HRQoL measure for this stage of the project, especially when this didn't change on pilot trials. I see in the author response that the PLS-5 and FOCUS-34 are now included in a secondary economic analysis, but cannot find this detail in the protocol itself. Overall, this is a comprehensive and impressive protocol which has potential to make substantial impact and contribution. The minor suggestions above are mainly intended to enhance replicability and to increase usefulness even further. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Developmental Language Disorder & other forms of atypical language development I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Botting N. Reviewer Report For: Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.21956/hrbopenres.15422.r43956 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-65/v2#referee-response-43956 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 31 Jan 2025 Pauline Frizelle , Department of Speech and Hearing Sciences, School of Clinical Therapies, University College Cork, Cork, Ireland 31 Jan 2025 Author Response Thank you for taking the time to give your valuable feedback. 1. RQ1: It might be helpful for readers to include 'compared to usual care' in RQ1. This is ... Continue reading Thank you for taking the time to give your valuable feedback. 1. RQ1: It might be helpful for readers to include 'compared to usual care' in RQ1. This is implied, but at the moment leaves the possibility that positive within-group change for the intervention group alone could answer this question (which is not the authors' intention). Response : We have added the clarification to RQ1 - that the intervention is being compared to usual care 2. Recruitment: Opt-in consent is being used. It would be useful to identify and detail any strategies for monitoring/ensuring that these sign ups represent low SES groups, as even within schools in disadvantaged areas, participation from some groups is difficult to attain. Would opt-out consent be considered if recruitment shows bias? Have the authors considered adding the option for a Qualtrics (or similar) link to consent, which we are finding useful in recruiting families where bits of paper get lost (I acknowledge this method has its own inherent biases, but maybe a combination?). Under Randomisation, it could be made clearer that the families are randomly selected *from consenting families*. The inclusion of families with additional languages is important, but it is not clear to me how the parent English level will be assessed. A small point but it is probably best to avoid the term 'subjects' even in a trial? Response: In relation to the profile of those who sign up, we appreciate that there will be variability in terms of levels of disadvantage. However, we will note these individual differences in the collection of our demographic data. As stated in response to another reviewer we acknowledge that the same variation will exist within the control settings and therefore should not be a confounding variable. In addition to the initial information session, our consent process is being facilitated by the pre/school staff who are available to read through the trial information and consent forms and answer any questions that potential participants might have when dropping and collecting their children. We appreciate the suggestion re Qualtrics but this would require access to a computer and feedback from pre/school staff is that they prefer to support the process in an informal way so that parents don’t feel under pressure to participate in the evaluation. There are large numbers of children receiving the intervention who are not part of the evaluation and if we were to engage in an opt out process, we would not have the capacity to assess them all in the restricted time frame. We have clarified that families are randomly selected from consenting families. As the reviewer rightly points out we are not actively assessing parents level of English and we have amended the text to remove the requirement of level B2. Parents will be asked if they are confident to complete the outcome measures without the need for an interpreter. We have replaced the term subjects, the use of which was an oversight on our part. 3. Data management: I have no doubt that this team are thoroughly conversant in data management, but for readers and replicability more detail about how data sharing (agreements), and transit across sites (and countries) will be securely achieved would be welcome. It would be useful to know who has overall responsibility for data governance and data backups etc. Response: This is a national study and therefore there is no data sharing between countries. We have made our data management plan available on OSF ( https://osf.io/ns7u5/ ) to address the reviewers point. 4. Training workshops: It was not clear to me how many people are at each workshop or included in the weekly video-conference support sessions. This detail seems important in terms of attendance bias, and success of the programme, and is needed for replicability. It would be useful to specify whether by 'recorded' you mean video or audio only. How will you deal with participants who do not give consent to recording or to other people in the background? Response: The workshops are for the pre/school staff and will be attended by the number who are participating in the intervention in a given pre/school, this varies from setting to setting and goes beyond those who are included in the trial. For example in some preschools there may be 3 staff (working in one room) where as others may have 5 across two rooms. We have clarified this in the text. We have specified that we will audio record the sessions, the therapist will wear a microphone, set to capture his/her input only. We appreciate that some child audio may be picked up in the distance but they will not be identifiable; we will not transcribe it (if audible); and we will not be using it in any way to measure interventionist fidelity. We have clarified that there will be 4 SLTs each year (8 in total) who will be attending the video-conference calls. 5. Assessment measures: In line with the other reviews, I am not sure about the CLASS and wondered whether authors had considered the CsC developed by Dockrell et al. for Better Communication? Will the reliability measures taken by an additional person occur at the same time or on a different day? In addition I wondered whether the FOCUS-34 has a reference? A couple of example questions might be useful here. For the MRBCS, I think this should read 'a total number of occurrences for each of four parental behaviours'? If not, more explanation is needed. Response: We used the CsC in our pilot trial and although we were not able to complete statistical analyses (due to a small number of settings) our observations of the data suggested that it was not sensitive to the expected changes. Empirical literature suggests that the CLASS is a reliable tool across a number of languages (Hamre et al., 2008; Stuck et al., 2016; Virtanen et al., 2017) and we expect sensitivity to a number of areas in which we aim to effect change - in particular Concept development, Quality of feedback and Language modelling . In addition, colleagues who have significant experience researching in the area of professional development of early years educators, have found the CLASS to be a sensitive measure (Eadie et. al.,). Because the CLASS is completed live, reliability checking will involve score checking only. However, to be deemed a reliable coder, all CLASS administrators are required to score within 1 point of master codes on 80% of all codes given in the training videos. We have added some references for the FOCUS-34, as well as some sample questions. We have reworded in relation to the MRBCS. 6. Economic assessment: I agree with other reviewers that it is confusing to use only the HRQoL measure for this stage of the project, especially when this didn't change on pilot trials. I see in the author response that the PLS-5 and FOCUS-34 are now included in a secondary economic analysis, but cannot find this detail in the protocol itself. Response: We have adapted the text to make the secondary (economic) analysis more explicit, specifying these two measures. Thank you for taking the time to give your valuable feedback. 1. RQ1: It might be helpful for readers to include 'compared to usual care' in RQ1. This is implied, but at the moment leaves the possibility that positive within-group change for the intervention group alone could answer this question (which is not the authors' intention). Response : We have added the clarification to RQ1 - that the intervention is being compared to usual care 2. Recruitment: Opt-in consent is being used. It would be useful to identify and detail any strategies for monitoring/ensuring that these sign ups represent low SES groups, as even within schools in disadvantaged areas, participation from some groups is difficult to attain. Would opt-out consent be considered if recruitment shows bias? Have the authors considered adding the option for a Qualtrics (or similar) link to consent, which we are finding useful in recruiting families where bits of paper get lost (I acknowledge this method has its own inherent biases, but maybe a combination?). Under Randomisation, it could be made clearer that the families are randomly selected *from consenting families*. The inclusion of families with additional languages is important, but it is not clear to me how the parent English level will be assessed. A small point but it is probably best to avoid the term 'subjects' even in a trial? Response: In relation to the profile of those who sign up, we appreciate that there will be variability in terms of levels of disadvantage. However, we will note these individual differences in the collection of our demographic data. As stated in response to another reviewer we acknowledge that the same variation will exist within the control settings and therefore should not be a confounding variable. In addition to the initial information session, our consent process is being facilitated by the pre/school staff who are available to read through the trial information and consent forms and answer any questions that potential participants might have when dropping and collecting their children. We appreciate the suggestion re Qualtrics but this would require access to a computer and feedback from pre/school staff is that they prefer to support the process in an informal way so that parents don’t feel under pressure to participate in the evaluation. There are large numbers of children receiving the intervention who are not part of the evaluation and if we were to engage in an opt out process, we would not have the capacity to assess them all in the restricted time frame. We have clarified that families are randomly selected from consenting families. As the reviewer rightly points out we are not actively assessing parents level of English and we have amended the text to remove the requirement of level B2. Parents will be asked if they are confident to complete the outcome measures without the need for an interpreter. We have replaced the term subjects, the use of which was an oversight on our part. 3. Data management: I have no doubt that this team are thoroughly conversant in data management, but for readers and replicability more detail about how data sharing (agreements), and transit across sites (and countries) will be securely achieved would be welcome. It would be useful to know who has overall responsibility for data governance and data backups etc. Response: This is a national study and therefore there is no data sharing between countries. We have made our data management plan available on OSF ( https://osf.io/ns7u5/ ) to address the reviewers point. 4. Training workshops: It was not clear to me how many people are at each workshop or included in the weekly video-conference support sessions. This detail seems important in terms of attendance bias, and success of the programme, and is needed for replicability. It would be useful to specify whether by 'recorded' you mean video or audio only. How will you deal with participants who do not give consent to recording or to other people in the background? Response: The workshops are for the pre/school staff and will be attended by the number who are participating in the intervention in a given pre/school, this varies from setting to setting and goes beyond those who are included in the trial. For example in some preschools there may be 3 staff (working in one room) where as others may have 5 across two rooms. We have clarified this in the text. We have specified that we will audio record the sessions, the therapist will wear a microphone, set to capture his/her input only. We appreciate that some child audio may be picked up in the distance but they will not be identifiable; we will not transcribe it (if audible); and we will not be using it in any way to measure interventionist fidelity. We have clarified that there will be 4 SLTs each year (8 in total) who will be attending the video-conference calls. 5. Assessment measures: In line with the other reviews, I am not sure about the CLASS and wondered whether authors had considered the CsC developed by Dockrell et al. for Better Communication? Will the reliability measures taken by an additional person occur at the same time or on a different day? In addition I wondered whether the FOCUS-34 has a reference? A couple of example questions might be useful here. For the MRBCS, I think this should read 'a total number of occurrences for each of four parental behaviours'? If not, more explanation is needed. Response: We used the CsC in our pilot trial and although we were not able to complete statistical analyses (due to a small number of settings) our observations of the data suggested that it was not sensitive to the expected changes. Empirical literature suggests that the CLASS is a reliable tool across a number of languages (Hamre et al., 2008; Stuck et al., 2016; Virtanen et al., 2017) and we expect sensitivity to a number of areas in which we aim to effect change - in particular Concept development, Quality of feedback and Language modelling . In addition, colleagues who have significant experience researching in the area of professional development of early years educators, have found the CLASS to be a sensitive measure (Eadie et. al.,). Because the CLASS is completed live, reliability checking will involve score checking only. However, to be deemed a reliable coder, all CLASS administrators are required to score within 1 point of master codes on 80% of all codes given in the training videos. We have added some references for the FOCUS-34, as well as some sample questions. We have reworded in relation to the MRBCS. 6. Economic assessment: I agree with other reviewers that it is confusing to use only the HRQoL measure for this stage of the project, especially when this didn't change on pilot trials. I see in the author response that the PLS-5 and FOCUS-34 are now included in a secondary economic analysis, but cannot find this detail in the protocol itself. Response: We have adapted the text to make the secondary (economic) analysis more explicit, specifying these two measures. Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 31 Jan 2025 Pauline Frizelle , Department of Speech and Hearing Sciences, School of Clinical Therapies, University College Cork, Cork, Ireland 31 Jan 2025 Author Response Thank you for taking the time to give your valuable feedback. 1. RQ1: It might be helpful for readers to include 'compared to usual care' in RQ1. This is ... Continue reading Thank you for taking the time to give your valuable feedback. 1. RQ1: It might be helpful for readers to include 'compared to usual care' in RQ1. This is implied, but at the moment leaves the possibility that positive within-group change for the intervention group alone could answer this question (which is not the authors' intention). Response : We have added the clarification to RQ1 - that the intervention is being compared to usual care 2. Recruitment: Opt-in consent is being used. It would be useful to identify and detail any strategies for monitoring/ensuring that these sign ups represent low SES groups, as even within schools in disadvantaged areas, participation from some groups is difficult to attain. Would opt-out consent be considered if recruitment shows bias? Have the authors considered adding the option for a Qualtrics (or similar) link to consent, which we are finding useful in recruiting families where bits of paper get lost (I acknowledge this method has its own inherent biases, but maybe a combination?). Under Randomisation, it could be made clearer that the families are randomly selected *from consenting families*. The inclusion of families with additional languages is important, but it is not clear to me how the parent English level will be assessed. A small point but it is probably best to avoid the term 'subjects' even in a trial? Response: In relation to the profile of those who sign up, we appreciate that there will be variability in terms of levels of disadvantage. However, we will note these individual differences in the collection of our demographic data. As stated in response to another reviewer we acknowledge that the same variation will exist within the control settings and therefore should not be a confounding variable. In addition to the initial information session, our consent process is being facilitated by the pre/school staff who are available to read through the trial information and consent forms and answer any questions that potential participants might have when dropping and collecting their children. We appreciate the suggestion re Qualtrics but this would require access to a computer and feedback from pre/school staff is that they prefer to support the process in an informal way so that parents don’t feel under pressure to participate in the evaluation. There are large numbers of children receiving the intervention who are not part of the evaluation and if we were to engage in an opt out process, we would not have the capacity to assess them all in the restricted time frame. We have clarified that families are randomly selected from consenting families. As the reviewer rightly points out we are not actively assessing parents level of English and we have amended the text to remove the requirement of level B2. Parents will be asked if they are confident to complete the outcome measures without the need for an interpreter. We have replaced the term subjects, the use of which was an oversight on our part. 3. Data management: I have no doubt that this team are thoroughly conversant in data management, but for readers and replicability more detail about how data sharing (agreements), and transit across sites (and countries) will be securely achieved would be welcome. It would be useful to know who has overall responsibility for data governance and data backups etc. Response: This is a national study and therefore there is no data sharing between countries. We have made our data management plan available on OSF ( https://osf.io/ns7u5/ ) to address the reviewers point. 4. Training workshops: It was not clear to me how many people are at each workshop or included in the weekly video-conference support sessions. This detail seems important in terms of attendance bias, and success of the programme, and is needed for replicability. It would be useful to specify whether by 'recorded' you mean video or audio only. How will you deal with participants who do not give consent to recording or to other people in the background? Response: The workshops are for the pre/school staff and will be attended by the number who are participating in the intervention in a given pre/school, this varies from setting to setting and goes beyond those who are included in the trial. For example in some preschools there may be 3 staff (working in one room) where as others may have 5 across two rooms. We have clarified this in the text. We have specified that we will audio record the sessions, the therapist will wear a microphone, set to capture his/her input only. We appreciate that some child audio may be picked up in the distance but they will not be identifiable; we will not transcribe it (if audible); and we will not be using it in any way to measure interventionist fidelity. We have clarified that there will be 4 SLTs each year (8 in total) who will be attending the video-conference calls. 5. Assessment measures: In line with the other reviews, I am not sure about the CLASS and wondered whether authors had considered the CsC developed by Dockrell et al. for Better Communication? Will the reliability measures taken by an additional person occur at the same time or on a different day? In addition I wondered whether the FOCUS-34 has a reference? A couple of example questions might be useful here. For the MRBCS, I think this should read 'a total number of occurrences for each of four parental behaviours'? If not, more explanation is needed. Response: We used the CsC in our pilot trial and although we were not able to complete statistical analyses (due to a small number of settings) our observations of the data suggested that it was not sensitive to the expected changes. Empirical literature suggests that the CLASS is a reliable tool across a number of languages (Hamre et al., 2008; Stuck et al., 2016; Virtanen et al., 2017) and we expect sensitivity to a number of areas in which we aim to effect change - in particular Concept development, Quality of feedback and Language modelling . In addition, colleagues who have significant experience researching in the area of professional development of early years educators, have found the CLASS to be a sensitive measure (Eadie et. al.,). Because the CLASS is completed live, reliability checking will involve score checking only. However, to be deemed a reliable coder, all CLASS administrators are required to score within 1 point of master codes on 80% of all codes given in the training videos. We have added some references for the FOCUS-34, as well as some sample questions. We have reworded in relation to the MRBCS. 6. Economic assessment: I agree with other reviewers that it is confusing to use only the HRQoL measure for this stage of the project, especially when this didn't change on pilot trials. I see in the author response that the PLS-5 and FOCUS-34 are now included in a secondary economic analysis, but cannot find this detail in the protocol itself. Response: We have adapted the text to make the secondary (economic) analysis more explicit, specifying these two measures. Thank you for taking the time to give your valuable feedback. 1. RQ1: It might be helpful for readers to include 'compared to usual care' in RQ1. This is implied, but at the moment leaves the possibility that positive within-group change for the intervention group alone could answer this question (which is not the authors' intention). Response : We have added the clarification to RQ1 - that the intervention is being compared to usual care 2. Recruitment: Opt-in consent is being used. It would be useful to identify and detail any strategies for monitoring/ensuring that these sign ups represent low SES groups, as even within schools in disadvantaged areas, participation from some groups is difficult to attain. Would opt-out consent be considered if recruitment shows bias? Have the authors considered adding the option for a Qualtrics (or similar) link to consent, which we are finding useful in recruiting families where bits of paper get lost (I acknowledge this method has its own inherent biases, but maybe a combination?). Under Randomisation, it could be made clearer that the families are randomly selected *from consenting families*. The inclusion of families with additional languages is important, but it is not clear to me how the parent English level will be assessed. A small point but it is probably best to avoid the term 'subjects' even in a trial? Response: In relation to the profile of those who sign up, we appreciate that there will be variability in terms of levels of disadvantage. However, we will note these individual differences in the collection of our demographic data. As stated in response to another reviewer we acknowledge that the same variation will exist within the control settings and therefore should not be a confounding variable. In addition to the initial information session, our consent process is being facilitated by the pre/school staff who are available to read through the trial information and consent forms and answer any questions that potential participants might have when dropping and collecting their children. We appreciate the suggestion re Qualtrics but this would require access to a computer and feedback from pre/school staff is that they prefer to support the process in an informal way so that parents don’t feel under pressure to participate in the evaluation. There are large numbers of children receiving the intervention who are not part of the evaluation and if we were to engage in an opt out process, we would not have the capacity to assess them all in the restricted time frame. We have clarified that families are randomly selected from consenting families. As the reviewer rightly points out we are not actively assessing parents level of English and we have amended the text to remove the requirement of level B2. Parents will be asked if they are confident to complete the outcome measures without the need for an interpreter. We have replaced the term subjects, the use of which was an oversight on our part. 3. Data management: I have no doubt that this team are thoroughly conversant in data management, but for readers and replicability more detail about how data sharing (agreements), and transit across sites (and countries) will be securely achieved would be welcome. It would be useful to know who has overall responsibility for data governance and data backups etc. Response: This is a national study and therefore there is no data sharing between countries. We have made our data management plan available on OSF ( https://osf.io/ns7u5/ ) to address the reviewers point. 4. Training workshops: It was not clear to me how many people are at each workshop or included in the weekly video-conference support sessions. This detail seems important in terms of attendance bias, and success of the programme, and is needed for replicability. It would be useful to specify whether by 'recorded' you mean video or audio only. How will you deal with participants who do not give consent to recording or to other people in the background? Response: The workshops are for the pre/school staff and will be attended by the number who are participating in the intervention in a given pre/school, this varies from setting to setting and goes beyond those who are included in the trial. For example in some preschools there may be 3 staff (working in one room) where as others may have 5 across two rooms. We have clarified this in the text. We have specified that we will audio record the sessions, the therapist will wear a microphone, set to capture his/her input only. We appreciate that some child audio may be picked up in the distance but they will not be identifiable; we will not transcribe it (if audible); and we will not be using it in any way to measure interventionist fidelity. We have clarified that there will be 4 SLTs each year (8 in total) who will be attending the video-conference calls. 5. Assessment measures: In line with the other reviews, I am not sure about the CLASS and wondered whether authors had considered the CsC developed by Dockrell et al. for Better Communication? Will the reliability measures taken by an additional person occur at the same time or on a different day? In addition I wondered whether the FOCUS-34 has a reference? A couple of example questions might be useful here. For the MRBCS, I think this should read 'a total number of occurrences for each of four parental behaviours'? If not, more explanation is needed. Response: We used the CsC in our pilot trial and although we were not able to complete statistical analyses (due to a small number of settings) our observations of the data suggested that it was not sensitive to the expected changes. Empirical literature suggests that the CLASS is a reliable tool across a number of languages (Hamre et al., 2008; Stuck et al., 2016; Virtanen et al., 2017) and we expect sensitivity to a number of areas in which we aim to effect change - in particular Concept development, Quality of feedback and Language modelling . In addition, colleagues who have significant experience researching in the area of professional development of early years educators, have found the CLASS to be a sensitive measure (Eadie et. al.,). Because the CLASS is completed live, reliability checking will involve score checking only. However, to be deemed a reliable coder, all CLASS administrators are required to score within 1 point of master codes on 80% of all codes given in the training videos. We have added some references for the FOCUS-34, as well as some sample questions. We have reworded in relation to the MRBCS. 6. Economic assessment: I agree with other reviewers that it is confusing to use only the HRQoL measure for this stage of the project, especially when this didn't change on pilot trials. I see in the author response that the PLS-5 and FOCUS-34 are now included in a secondary economic analysis, but cannot find this detail in the protocol itself. Response: We have adapted the text to make the secondary (economic) analysis more explicit, specifying these two measures. Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Rowe ML. Reviewer Report For: Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.21956/hrbopenres.15422.r43949 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-65/v2#referee-response-43949 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 06 Jan 2025 Meredith L. Rowe , Harvard University, Cambridge, USA Approved VIEWS 0 https://doi.org/10.21956/hrbopenres.15422.r43949 Review of Study Protocol: “Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial” for HRB Open Research. This is a proposed RCT to examine effects of ... Continue reading READ ALL Review of Study Protocol: “Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial” for HRB Open Research. This is a proposed RCT to examine effects of the Happy Talk intervention for preschool educators and parents on preschool children’s language outcomes in Ireland. The literature review does a good job of making the case for the need (the low language skills in areas of social disadvantage) and for the approach (targeting teachers and parents) in this effectiveness trial in the community. Is the rationale for, and objectives of, the study clearly described? Yes, for the most part, the research questions are clear and follow from the literature review. My only question is about RQ4 and any hypotheses regarding the specific program features or contextual factors. If there are no specific hypotheses here, and if this RQ is under-powered statistically, the authors might list this as an “exploratory analysis”. Is the study design appropriate for the research question? The longitudinal cluster randomized design is appropriate. I have a few small questions about the methods where more information could be provided. -are the randomly chosen 12 participants all going to be from lower-SES backgrounds? This seems important given the rationale -are the parents compensated for attending the sessions? What is the motivation for them and feasibility of them showing up based on prior work with this intervention? I see they are compensated when the child gets tested, but also for their own participation or do they opt in without this added incentive? -it might be important to see if the children in the classrooms of “communication champions” do better than those in other treatment classrooms -I wonder if a more nuanced measure of classroom language would be helpful in addition to the CLASS. That is, if is it possible to audiotape a short “circle time” session for each participating teacher during the CLASS observation then this segment could be coded for teacher and classroom language use. For example, how many questions the teacher asks, how many children contribute to conversations, how extended the conversations are, etc. This would be similar to the MRBCS but in the classroom context. This is understandably a fair amount of work to record, and potentially transcribe and code, but it may result in a lot more variability in relevant measures than the CLASS and also in some insights as to the specific mechanisms of effects. -Also, I would suggest potentially coding the child speech in the MRBCS samples as an additional measure of child language/vocabulary. *these last two comments are based on the fact that many parent and preschool interventions have a hard time ‘moving the needle’ on standardized tests but are more likely to show effects on the day-to-day practices that are promoted. I worry that the vast majority of the measures here are more global and standardized and more subtle effects might be missed. If coding videos is too time-consuming, maybe something like the Language Use Inventory (McNeill) that can be filled out by the teacher and the parent (of course there are bias issues here because of parent/teacher reporting). Are sufficient details of the methods provided to allow replication by others? Yes, it appears so as long as the intervention itself is publicly available. Are the datasets clearly presented in a useable and accessible format? Data analysis and monitoring plans seem appropriate. -I am wondering if some children will potentially have a teacher who participated in the intervention 2 years and others just have 1 teacher and then a non-intervention teacher for the 1- year follow up? If this is the case, this factor needs to be controlled/examined or potentially manipulated in classroom placement for the children randomly chosen to participate. -the economic analysis is a strength of this study. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Language development, parenting, parent interventions, early childhood I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Rowe ML. Reviewer Report For: Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.21956/hrbopenres.15422.r43949 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-65/v2#referee-response-43949 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 24 Jan 2025 Pauline Frizelle , Department of Speech and Hearing Sciences, School of Clinical Therapies, University College Cork, Cork, Ireland 24 Jan 2025 Author Response Many thanks for your valuable feedback - we have addressed each point in turn Are the randomly chosen 12 participants all going to be from lower-SES backgrounds? This seems ... Continue reading Many thanks for your valuable feedback - we have addressed each point in turn Are the randomly chosen 12 participants all going to be from lower-SES backgrounds? This seems important given the rationale Response: The profile of all settings is that they are in significantly disadvantaged areas and are designated DEIS pre/schools in Ireland (Delivering Equality and Opportunity in schools). We appreciate that there will be different degrees of disadvantage within a given setting, however, we will note these individual differences in the collection of our demographic data. We acknowledge that the same variation will exist within the control settings and therefore should not be a confounding variable. Are the parents compensated for attending the sessions? What is the motivation for them and feasibility of them showing up based on prior work with this intervention? I see they are compensated when the child gets tested, but also for their own participation or do they opt in without this added incentive? Response: Parents are not compensated for attending the sessions, they opt in without additional incentives. In areas where Happy Talk is well established there is very high attendance as other parents/educators have spoken so positively about the programme and parents have an expectation that this will be part of their child’s education. In new areas (as is the case here) attendance tends to increase as the programme progresses. Parents become more committed as their confidence increases, and children request their parents to be present in the classroom, as they enjoy this aspect of the programme. it might be important to see if the children in the classrooms of “communication champions” do better than those in other treatment classrooms Response: There will be a communication champion in all rooms in which there are children attending Happy Talk. We have clarified this in the text. I wonder if a more nuanced measure of classroom language would be helpful in addition to the CLASS. That is, if is it possible to audiotape a short “circle time” session for each participating teacher during the CLASS observation then this segment could be coded for teacher and classroom language use. For example, how many questions the teacher asks, how many children contribute to conversations, how extended the conversations are, etc. This would be similar to the MRBCS but in the classroom context. This is understandably a fair amount of work to record, and potentially transcribe and code, but it may result in a lot more variability in relevant measures than the CLASS and also in some insights as to the specific mechanisms of effects. -Also, I would suggest potentially coding the child speech in the MRBCS samples as an additional measure of child language/vocabulary. Response: We appreciate the reviewers comments with respect to capturing the day to day changes in child language and interaction. We are using the FOCUS-34 with the aim of capturing these functional changes at home and in school. Unfortunately time constraints and resources prevent us from recording and coding sessions in the classroom. There are also ethical issues as we would be actively recording children who have consented to receiving Happy Talk but have not consented to participate in the evaluation. We are cognisant of the burden of evaluation on families and for this reason, do not want to introduce any further outcome measures. We are reluctant to use the language produced during the MRBCS as a measure of child language /vocabulary for the reasons outlined in response to reviewer 1. Specifically, the videotape segment is intended to capture the use of language promoting strategies used by parents, is a very short sample, and subject to significant variability due to differences in parental scaffolding. As such we would be concerned that it would not yield reliable MLU estimates due to the need for a considerable number of turns for such reliability. Also given that parents differ in their communication style, which affects the amount of language used by a child, this could be a confounding variable if we were to use the videos as estimates of language ability. *these last two comments are based on the fact that many parent and preschool interventions have a hard time ‘moving the needle’ on standardized tests but are more likely to show effects on the day-to-day practices that are promoted. I worry that the vast majority of the measures here are more global and standardized and more subtle effects might be missed. If coding videos is too time-consuming, maybe something like the Language Use Inventory (McNeill) that can be filled out by the teacher and the parent (of course there are bias issues here because of parent/teacher reporting). I am wondering if some children will potentially have a teacher who participated in the intervention 2 years and others just have 1 teacher and then a non-intervention teacher for the 1- year follow up? If this is the case, this factor needs to be controlled/examined or potentially manipulated in classroom placement for the children randomly chosen to participate. Response: All educators and children will only participate in the intervention for one year. However, it is possible that some children will progress from an intervention preschool to a school that also participated in the intervention and where the teacher was trained in the Happy Talk programme. We will control for this factor. Many thanks for your valuable feedback - we have addressed each point in turn Are the randomly chosen 12 participants all going to be from lower-SES backgrounds? This seems important given the rationale Response: The profile of all settings is that they are in significantly disadvantaged areas and are designated DEIS pre/schools in Ireland (Delivering Equality and Opportunity in schools). We appreciate that there will be different degrees of disadvantage within a given setting, however, we will note these individual differences in the collection of our demographic data. We acknowledge that the same variation will exist within the control settings and therefore should not be a confounding variable. Are the parents compensated for attending the sessions? What is the motivation for them and feasibility of them showing up based on prior work with this intervention? I see they are compensated when the child gets tested, but also for their own participation or do they opt in without this added incentive? Response: Parents are not compensated for attending the sessions, they opt in without additional incentives. In areas where Happy Talk is well established there is very high attendance as other parents/educators have spoken so positively about the programme and parents have an expectation that this will be part of their child’s education. In new areas (as is the case here) attendance tends to increase as the programme progresses. Parents become more committed as their confidence increases, and children request their parents to be present in the classroom, as they enjoy this aspect of the programme. it might be important to see if the children in the classrooms of “communication champions” do better than those in other treatment classrooms Response: There will be a communication champion in all rooms in which there are children attending Happy Talk. We have clarified this in the text. I wonder if a more nuanced measure of classroom language would be helpful in addition to the CLASS. That is, if is it possible to audiotape a short “circle time” session for each participating teacher during the CLASS observation then this segment could be coded for teacher and classroom language use. For example, how many questions the teacher asks, how many children contribute to conversations, how extended the conversations are, etc. This would be similar to the MRBCS but in the classroom context. This is understandably a fair amount of work to record, and potentially transcribe and code, but it may result in a lot more variability in relevant measures than the CLASS and also in some insights as to the specific mechanisms of effects. -Also, I would suggest potentially coding the child speech in the MRBCS samples as an additional measure of child language/vocabulary. Response: We appreciate the reviewers comments with respect to capturing the day to day changes in child language and interaction. We are using the FOCUS-34 with the aim of capturing these functional changes at home and in school. Unfortunately time constraints and resources prevent us from recording and coding sessions in the classroom. There are also ethical issues as we would be actively recording children who have consented to receiving Happy Talk but have not consented to participate in the evaluation. We are cognisant of the burden of evaluation on families and for this reason, do not want to introduce any further outcome measures. We are reluctant to use the language produced during the MRBCS as a measure of child language /vocabulary for the reasons outlined in response to reviewer 1. Specifically, the videotape segment is intended to capture the use of language promoting strategies used by parents, is a very short sample, and subject to significant variability due to differences in parental scaffolding. As such we would be concerned that it would not yield reliable MLU estimates due to the need for a considerable number of turns for such reliability. Also given that parents differ in their communication style, which affects the amount of language used by a child, this could be a confounding variable if we were to use the videos as estimates of language ability. *these last two comments are based on the fact that many parent and preschool interventions have a hard time ‘moving the needle’ on standardized tests but are more likely to show effects on the day-to-day practices that are promoted. I worry that the vast majority of the measures here are more global and standardized and more subtle effects might be missed. If coding videos is too time-consuming, maybe something like the Language Use Inventory (McNeill) that can be filled out by the teacher and the parent (of course there are bias issues here because of parent/teacher reporting). I am wondering if some children will potentially have a teacher who participated in the intervention 2 years and others just have 1 teacher and then a non-intervention teacher for the 1- year follow up? If this is the case, this factor needs to be controlled/examined or potentially manipulated in classroom placement for the children randomly chosen to participate. Response: All educators and children will only participate in the intervention for one year. However, it is possible that some children will progress from an intervention preschool to a school that also participated in the intervention and where the teacher was trained in the Happy Talk programme. We will control for this factor. Competing Interests: No competing interests were disclosed. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 24 Jan 2025 Pauline Frizelle , Department of Speech and Hearing Sciences, School of Clinical Therapies, University College Cork, Cork, Ireland 24 Jan 2025 Author Response Many thanks for your valuable feedback - we have addressed each point in turn Are the randomly chosen 12 participants all going to be from lower-SES backgrounds? This seems ... Continue reading Many thanks for your valuable feedback - we have addressed each point in turn Are the randomly chosen 12 participants all going to be from lower-SES backgrounds? This seems important given the rationale Response: The profile of all settings is that they are in significantly disadvantaged areas and are designated DEIS pre/schools in Ireland (Delivering Equality and Opportunity in schools). We appreciate that there will be different degrees of disadvantage within a given setting, however, we will note these individual differences in the collection of our demographic data. We acknowledge that the same variation will exist within the control settings and therefore should not be a confounding variable. Are the parents compensated for attending the sessions? What is the motivation for them and feasibility of them showing up based on prior work with this intervention? I see they are compensated when the child gets tested, but also for their own participation or do they opt in without this added incentive? Response: Parents are not compensated for attending the sessions, they opt in without additional incentives. In areas where Happy Talk is well established there is very high attendance as other parents/educators have spoken so positively about the programme and parents have an expectation that this will be part of their child’s education. In new areas (as is the case here) attendance tends to increase as the programme progresses. Parents become more committed as their confidence increases, and children request their parents to be present in the classroom, as they enjoy this aspect of the programme. it might be important to see if the children in the classrooms of “communication champions” do better than those in other treatment classrooms Response: There will be a communication champion in all rooms in which there are children attending Happy Talk. We have clarified this in the text. I wonder if a more nuanced measure of classroom language would be helpful in addition to the CLASS. That is, if is it possible to audiotape a short “circle time” session for each participating teacher during the CLASS observation then this segment could be coded for teacher and classroom language use. For example, how many questions the teacher asks, how many children contribute to conversations, how extended the conversations are, etc. This would be similar to the MRBCS but in the classroom context. This is understandably a fair amount of work to record, and potentially transcribe and code, but it may result in a lot more variability in relevant measures than the CLASS and also in some insights as to the specific mechanisms of effects. -Also, I would suggest potentially coding the child speech in the MRBCS samples as an additional measure of child language/vocabulary. Response: We appreciate the reviewers comments with respect to capturing the day to day changes in child language and interaction. We are using the FOCUS-34 with the aim of capturing these functional changes at home and in school. Unfortunately time constraints and resources prevent us from recording and coding sessions in the classroom. There are also ethical issues as we would be actively recording children who have consented to receiving Happy Talk but have not consented to participate in the evaluation. We are cognisant of the burden of evaluation on families and for this reason, do not want to introduce any further outcome measures. We are reluctant to use the language produced during the MRBCS as a measure of child language /vocabulary for the reasons outlined in response to reviewer 1. Specifically, the videotape segment is intended to capture the use of language promoting strategies used by parents, is a very short sample, and subject to significant variability due to differences in parental scaffolding. As such we would be concerned that it would not yield reliable MLU estimates due to the need for a considerable number of turns for such reliability. Also given that parents differ in their communication style, which affects the amount of language used by a child, this could be a confounding variable if we were to use the videos as estimates of language ability. *these last two comments are based on the fact that many parent and preschool interventions have a hard time ‘moving the needle’ on standardized tests but are more likely to show effects on the day-to-day practices that are promoted. I worry that the vast majority of the measures here are more global and standardized and more subtle effects might be missed. If coding videos is too time-consuming, maybe something like the Language Use Inventory (McNeill) that can be filled out by the teacher and the parent (of course there are bias issues here because of parent/teacher reporting). I am wondering if some children will potentially have a teacher who participated in the intervention 2 years and others just have 1 teacher and then a non-intervention teacher for the 1- year follow up? If this is the case, this factor needs to be controlled/examined or potentially manipulated in classroom placement for the children randomly chosen to participate. Response: All educators and children will only participate in the intervention for one year. However, it is possible that some children will progress from an intervention preschool to a school that also participated in the intervention and where the teacher was trained in the Happy Talk programme. We will control for this factor. Many thanks for your valuable feedback - we have addressed each point in turn Are the randomly chosen 12 participants all going to be from lower-SES backgrounds? This seems important given the rationale Response: The profile of all settings is that they are in significantly disadvantaged areas and are designated DEIS pre/schools in Ireland (Delivering Equality and Opportunity in schools). We appreciate that there will be different degrees of disadvantage within a given setting, however, we will note these individual differences in the collection of our demographic data. We acknowledge that the same variation will exist within the control settings and therefore should not be a confounding variable. Are the parents compensated for attending the sessions? What is the motivation for them and feasibility of them showing up based on prior work with this intervention? I see they are compensated when the child gets tested, but also for their own participation or do they opt in without this added incentive? Response: Parents are not compensated for attending the sessions, they opt in without additional incentives. In areas where Happy Talk is well established there is very high attendance as other parents/educators have spoken so positively about the programme and parents have an expectation that this will be part of their child’s education. In new areas (as is the case here) attendance tends to increase as the programme progresses. Parents become more committed as their confidence increases, and children request their parents to be present in the classroom, as they enjoy this aspect of the programme. it might be important to see if the children in the classrooms of “communication champions” do better than those in other treatment classrooms Response: There will be a communication champion in all rooms in which there are children attending Happy Talk. We have clarified this in the text. I wonder if a more nuanced measure of classroom language would be helpful in addition to the CLASS. That is, if is it possible to audiotape a short “circle time” session for each participating teacher during the CLASS observation then this segment could be coded for teacher and classroom language use. For example, how many questions the teacher asks, how many children contribute to conversations, how extended the conversations are, etc. This would be similar to the MRBCS but in the classroom context. This is understandably a fair amount of work to record, and potentially transcribe and code, but it may result in a lot more variability in relevant measures than the CLASS and also in some insights as to the specific mechanisms of effects. -Also, I would suggest potentially coding the child speech in the MRBCS samples as an additional measure of child language/vocabulary. Response: We appreciate the reviewers comments with respect to capturing the day to day changes in child language and interaction. We are using the FOCUS-34 with the aim of capturing these functional changes at home and in school. Unfortunately time constraints and resources prevent us from recording and coding sessions in the classroom. There are also ethical issues as we would be actively recording children who have consented to receiving Happy Talk but have not consented to participate in the evaluation. We are cognisant of the burden of evaluation on families and for this reason, do not want to introduce any further outcome measures. We are reluctant to use the language produced during the MRBCS as a measure of child language /vocabulary for the reasons outlined in response to reviewer 1. Specifically, the videotape segment is intended to capture the use of language promoting strategies used by parents, is a very short sample, and subject to significant variability due to differences in parental scaffolding. As such we would be concerned that it would not yield reliable MLU estimates due to the need for a considerable number of turns for such reliability. Also given that parents differ in their communication style, which affects the amount of language used by a child, this could be a confounding variable if we were to use the videos as estimates of language ability. *these last two comments are based on the fact that many parent and preschool interventions have a hard time ‘moving the needle’ on standardized tests but are more likely to show effects on the day-to-day practices that are promoted. I worry that the vast majority of the measures here are more global and standardized and more subtle effects might be missed. If coding videos is too time-consuming, maybe something like the Language Use Inventory (McNeill) that can be filled out by the teacher and the parent (of course there are bias issues here because of parent/teacher reporting). I am wondering if some children will potentially have a teacher who participated in the intervention 2 years and others just have 1 teacher and then a non-intervention teacher for the 1- year follow up? If this is the case, this factor needs to be controlled/examined or potentially manipulated in classroom placement for the children randomly chosen to participate. Response: All educators and children will only participate in the intervention for one year. However, it is possible that some children will progress from an intervention preschool to a school that also participated in the intervention and where the teacher was trained in the Happy Talk programme. We will control for this factor. Competing Interests: No competing interests were disclosed. Close Report a concern COMMENT ON THIS REPORT Version 1 VERSION 1 PUBLISHED 08 Oct 2024 Views 0 Cite How to cite this report: Feldman H. Reviewer Report For: Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.21956/hrbopenres.15338.r42876 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-65/v1#referee-response-42876 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 25 Nov 2024 Heidi Feldman , Stanford University, Stanford, California, USA Approved with Reservations VIEWS 0 https://doi.org/10.21956/hrbopenres.15338.r42876 Background: Social disadvantage is associated with delays and disorders in language development. Previous studies have found that parent- or school-language enrichment programs are associated with slight to modest gains in child language outcomes. This study protocol combines both parent and ... Continue reading READ ALL Background: Social disadvantage is associated with delays and disorders in language development. Previous studies have found that parent- or school-language enrichment programs are associated with slight to modest gains in child language outcomes. This study protocol combines both parent and school language enrichment in an effort to maximize the positive impact. Study design: The proposed study is a large scale cluster randomised trial of a 12-week manualised intervention delivered in pre/school settings serving socially disadvantaged communities, in Ireland. 72 clusters receive the intervention (12 participants per cluster). Parents and pre/school staff engage in group training and coaching in the form of 12 1-hour sessions for parents and four staff workshops for educators, over the course of the 8-month pre/school year. Is the rationale for, and objectives of, the study clearly described? The study rests on reliable observations that children from disadvantaged backgrounds have disproportionately higher rates of early and persistent language disorders than children from advantaged backgrounds. Language disorders predict important impacts for educational and occupational outcomes. The scope of this problem makes addressing language delay in poor communities an appropriate public health target. Further, given the high prevalence, a “tier 1” intervention, offered universally and preventatively, is highly appropriate. Previous linguistic and auditory intervention efforts directed to preschool educators have yielded variable findings and, at best, improvements with only modest effect sizes. Professional literacy interventions have been somewhat better for reading outcomes with little generalization to language. Similarly, preventive parent-directed interventions are also associated with small to moderate effect sizes. Based on this review, the investigators plan to provide intervention in more than a single environment, aimed at both home and school. Pilot data from Happy Talk in a single community of Ireland are promising, though other studies show no additional benefit. The questions and hypotheses are clear and comprehensive. Is the study design appropriate for the research question? The study is a cluster-randomized controlled trial taking place over three years. The intervention period is 8 months with immediate and delayed follow-up. This design is appropriate and feasible as an effectiveness tiral. Participants will be targeted for recruitment from 4 Community Healthcare Organizations based on level of social disadvantage using a deprivation index. These decisions are appropriate. Exclusion criteria are reasonable. The intervention is a manualized training and support programme delivered by Speech-Language Therapists (SLTs) to parents and early childhood educators. One concerning feature about the protocol is that the child participants are aged 0-6. This broad age range is problematic because the parent coaching for a 5–6-year-old would be exceedingly different from the appropriate strategies for a 1-2 year old. Limiting the intervention to 18 or 24 months of age to 36 months of age might be a better test of the protocol. Another potentially concerning feature is that the parent intervention component requires 12 1-hour sessions in 4-week blocks and in 2 additional 30-minute units over the school year. The investigators offer no rationale for this schedule. There is no mention of engaging potential participants in the development of the curriculum and specifically in the duration or timing of these sessions. The investigators plan a 2–3-week engagement phase with each school to build relationships, but parents are not included. The 30 minute segments are in person at the center with direct coaching with parent and child. When in the course of the program will they be completed? There is no discussion about the 12 1-hour sessions. Are they in person? Online? Does this schedule work for working and busy parents? There is also no discussion about the parents’ adherence to the plan. The outcome measures mention maternal responsiveness. Can fathers or other caregivers participate? The Happy Talk intervention will be compared to treatment as usual (TAU). This decision is very reasonable. The primary child outcome measures are the Pre-School Language Scales, 5 th edition and Focus on Outcomes of Communication Under 6, which is a parent report measure. The use of a parent-report measure introduces potential bias because the intervention targets parents. The secondary child measures, the PedsQL asks only about communication problems and is therefore likely to be highly insensitive in this setting. The other secondary outcome, the Child Health Utility Instrument is yet another caregiver-completed questionnaire and has nothing to do with the interventions being offered. Why should quality of life change? Note that the educators are not providing any ratings as outcome measures. Other potential ratings, such as a functional measure (ABBAS or Vineland) could be considered and these measures can be completed by parents and teachers.. There are two additional secondary measures—the Maternal Responsive Behavior Coding scheme and the Classroom Assessment Scoring System. Are fathers also invited to parent sessions? Why use a maternal measure? Rather than conceptualizing these measures as outcomes, they could be conceptualized as fidelity checks on the parents and teachers. Then changes in them could be considered mediators of change in the child outcomes. If parents or teachers are not changing as a function of the training, it is unlikely that the intervention will be successful. Note that the maternal responsiveness measure will be based on a videotape segment. Could the child's language in this segment be an outcome? Power analyses and the intention to treat rationale are well described. There is no rationale for the HRQoL in the economic analyses. Why should this assessment be sensitive to language interventions? Another potential program is the randomization of sites scheme. The investigators have not discussed the implications if a site that participated in Round 1 of the intervention is randomized to be control in Round 2. Isn’t it likely that those trained educators will continue to use what they have learned in the next round? What about if classes contain siblings of previous participants? Economic analyses are planned. The primary measures will be the standardised Health Related Quality of Life (HRQoL) questionnaires pre-, post- and at 12 months follow-up. HRQoL measures enable the calculation of Quality Adjusted Life Years (QALYs) as well as an investigation of the sensitivity of these measures with children. The investigators are wary of the plan. It is unclear how QALYs relate to the improvement in language skills anticipated in this trial. Could other methods be used, such as functional assessment (what is the value of increasing a child’s standard score on a functional measure in terms of later outcomes?) Are sufficient details of the methods provided to allow replication by others? The protocol is very detailed. The curricula are not included but other than that, the study is reproducible. Are the datasets clearly presented in a useable and accessible format? Not applicable. In summary, this ambitious trial may have important public health implications for disadvantaged children in Ireland and beyond. The study could be strengthened with adjustments in the planned methods: Narrow the age range of participants. Infants less than one and children over about 4 need different types of language input than toddlers and young preschoolers. Engage parents in developing their intervention. Check on their ability to attend 12 1-hour sessions. Consider the secondary measures as fidelity checks on parents and educators and adjust the statistical analyses accordingly. Secondary child outcomes are weak. They rely on parent reports and are not sensitive to advances, but rather child weaknesses. No educator ratings are planned. Why not use a functional measure, such as the Vineland. Alternatively, the investigators could code child language from the MRBC videos. Consider dropping the health-related quality-of-life measure as it has no relation to the intervention. Rethink the economic analyses based on QALYs and HRQOL. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: language development, developmental disabilities, pediatrics, developmental neuroscience I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Feldman H. Reviewer Report For: Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.21956/hrbopenres.15338.r42876 ) The direct URL for this report is: https://hrbopenresearch.org/articles/7-65/v1#referee-response-42876 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 12 Dec 2024 Pauline Frizelle , Department of Speech and Hearing Sciences, School of Clinical Therapies, University College Cork, Cork, Ireland 12 Dec 2024 Author Response We thank the reviewer for her positive evaluation of the protocol, and for the suggestions she has made to improve it. We document here how we have responded to each ... Continue reading We thank the reviewer for her positive evaluation of the protocol, and for the suggestions she has made to improve it. We document here how we have responded to each point. A point of clarification - The reviewer notes that participants will be targeted for recruitment from 4 Community Healthcare Organizations (CHOs) based on level of social disadvantage using a deprivation index. Participants will be recruited from 8 Community Healthcare Organizations (4 each year). Narrow the age range of participants. Infants less than one and children over about 4 need different types of language input than toddlers and young preschoolers. Response - The reviewer notes that it is concerning that child participants span a very broad age range i.e. 0-6. For clarification, the overall Happy Talk programme provides services for children 0-6 years, but this evaluation is focussed on the preschool programme only, which ranges from 2;10 months to a maximum of 6 years. However the majority of children fall within the 3 – 5 year age range. Engage parents in developing their intervention. Check on their ability to attend 12 1-hour sessions. When in the course of the program will they be completed? There is no discussion about the 12 1-hour sessions. Are they in person? Online? Response – This intervention has been implemented in one area of Ireland (to over 80 settings) for in excess of 11 years. The feasibility of the programme with parents living in socially disadvantaged areas has long been established. Feedback from parents and early years educators has been embedded in the programme since it was first developed. We realise that there will always be variability in parental attendance particularly when a programme is not yet established in an area. We had specified that the 12 1 hours sessions took place in 4 week blocks, 1 between September and December, 1 between January and March and 1 between April and June. We have clarified that they are in person. Consider the secondary measures as fidelity checks on parents and educators and adjust the statistical analyses accordingly. Rather than conceptualizing these measures as outcomes, they could be conceptualized as fidelity checks on the parents and teachers. Then changes in them could be considered mediators of change in the child outcomes. If parents or teachers are not changing as a function of the training, it is unlikely that the intervention will be successful. Note that the maternal responsiveness measure will be based on a videotape segment. Could the child's language in this segment be an outcome? Response: In line with the reviewer and our logic model/ theory of change, we consider both the parent and educator outcome measures as mediators of change in the child outcomes. In our pilot trial we were unable to show significant change in our parent group and did not have a sufficient number of settings to explore the impact of potential changes in the preschool environment. Despite this, the intervention had a large effect on the participating children. However, we will add an exploratory set of models to the statistical analysis plan aimed at evaluating heterogeneity in treatment effects on child outcomes as a function of parent and educator outcomes. In addition, parents and teachers will be completing their own separate fidelity checks and 20% of the intervention sessions will also be coded for fidelity against the manual. The videotape segment is intended to capture the use of language promoting strategies used by parents, is a very short sample, and subject to significant variability due to differences in parental scaffolding. As such we would be concerned that it would not yield reliable MLU estimates due to the need for a considerable number of turns for such reliability. Also given that parents differ in their communication style, which affects the amount of language used by a child, this could be a confounding variable if we were to use the videos as estimates of language ability. Secondary child outcomes are weak. They rely on parent reports and are not sensitive to advances, but rather child weaknesses. No educator ratings are planned. Why not use a functional measure, such as the Vineland. Alternatively, the investigators could code child language from the MRBC videos. Response: We are capturing changes in child language through our primary outcomes measures, a standardized composite language measure (the PLS- 5) and a functional measure (the FOCUS- 34). Changes in parent behaviour are captured through the MRBCS, - an observation schedule shown to capture key characteristics associated with language growth over time (Down et al., 2015; Levickis et al., 2014; Smith et al., 2019) . The secondary outcome measures are as the reviewer suggests parent proxy measures, however literature suggests that parental measures are considered reliable and with acceptable concurrent validity (Feldman et al., 2005). The CLASS secondary outcome measure is a reliable measure which will allow us to assess change in the quality of interactions between teachers and students in the classroom, this is an aspect of our logic model which we deem important to capture. The Vineland is a measure of overall cognition rather than one that focuses specifically on language. We have not included educator ratings of children, as the staff working with children are not always consistent and they are working with large groups of children, only some of which are included in the evaluation. We do not want them to focus their attention/prioritise those in the evaluation over and above those who are not. Consider dropping the health-related quality-of-life measure as it has no relation to the intervention. Response – We agree that the HRQL measures are not ideal and may not be sensitive to the changes that we expect as a result of our intervention, this was the case in our pilot trial. However, our pilot trial assessments took place over a short time period and it is not recommended to complete these measures over a period shorter than a year. Improvement in language outcomes are associated with overall well-being and these HRQL measures do ask about communication, which is at the core of our intervention. We do not have other measures at our disposal that can generate QALYs and are therefore suitable for a primary cost effectiveness analysis. Rethink the economic analyses based on QALYs and HRQOL. Response - We have given these measures considerable thought and in discussion with our health economist had decided to include them as they are not onerous to complete and there are currently no better alternatives. We have however also included the FOCUS – 34 as our functional measure and the PLS-5 scores will be used in our secondary cost effectiveness analysis. Our pilot trial included a value of information analysis, and indicated that there was value in collecting further information in a large scale trial. The randomization of sites scheme. The investigators have not discussed the implications if a site that participated in Round 1 of the intervention is randomized to be control in Round 2. Isn’t it likely that those trained educators will continue to use what they have learned in the next round? What about if classes contain siblings of previous participants? Response - Round 2 will involve the recruitment of 4 additional sites (in different areas) and will have no relationship with the sites recruited in round 1. Down, K., Levickis, P., Hudson, S., Nicholls, R. and Wake, M. (2015), Measuring maternal responsiveness. Child Care Health Dev, 41: 329-333. https://doi.org/10.1111/cch.12174 Feldman HM, Dale PS, Campbell TF, Colborn DK, Kurs-Lasky M, Rockette HE, Paradise JL. Concurrent and predictive validity of parent reports of child language at ages 2 and 3 years. Child Dev. 2005 Jul-Aug;76(4):856-68. doi: 10.1111/j.1467-8624.2005.00882.x. PMID: 16026501; PMCID: PMC1350485. Levickis, Penny PhD *,†,‡ ; Reilly, Sheena PhD *,‡ ; Girolametto, Luigi PhD § ; Ukoumunne, Obioha C. PhD ‖ ; Wake, Melissa MD *,†,‡ . Maternal Behaviors Promoting Language Acquisition in Slow-to-Talk Toddlers: Prospective Community-based Study. Journal of Developmental & Behavioral Pediatrics 35(4):p 274-281, May 2014. | DOI: 10.1097/DBP.0000000000000056 Smith, J., Levickis, P., Eadie, T., Bretherton, L., Conway, L., & Goldfeld, S. (2019). Associations between early maternal behaviours and child language at 36 months in a cohort experiencing adversity. International journal of language & communication disorders , 54 (1), 110–122. https://doi.org/10.1111/1460-6984.12435 We thank the reviewer for her positive evaluation of the protocol, and for the suggestions she has made to improve it. We document here how we have responded to each point. A point of clarification - The reviewer notes that participants will be targeted for recruitment from 4 Community Healthcare Organizations (CHOs) based on level of social disadvantage using a deprivation index. Participants will be recruited from 8 Community Healthcare Organizations (4 each year). Narrow the age range of participants. Infants less than one and children over about 4 need different types of language input than toddlers and young preschoolers. Response - The reviewer notes that it is concerning that child participants span a very broad age range i.e. 0-6. For clarification, the overall Happy Talk programme provides services for children 0-6 years, but this evaluation is focussed on the preschool programme only, which ranges from 2;10 months to a maximum of 6 years. However the majority of children fall within the 3 – 5 year age range. Engage parents in developing their intervention. Check on their ability to attend 12 1-hour sessions. When in the course of the program will they be completed? There is no discussion about the 12 1-hour sessions. Are they in person? Online? Response – This intervention has been implemented in one area of Ireland (to over 80 settings) for in excess of 11 years. The feasibility of the programme with parents living in socially disadvantaged areas has long been established. Feedback from parents and early years educators has been embedded in the programme since it was first developed. We realise that there will always be variability in parental attendance particularly when a programme is not yet established in an area. We had specified that the 12 1 hours sessions took place in 4 week blocks, 1 between September and December, 1 between January and March and 1 between April and June. We have clarified that they are in person. Consider the secondary measures as fidelity checks on parents and educators and adjust the statistical analyses accordingly. Rather than conceptualizing these measures as outcomes, they could be conceptualized as fidelity checks on the parents and teachers. Then changes in them could be considered mediators of change in the child outcomes. If parents or teachers are not changing as a function of the training, it is unlikely that the intervention will be successful. Note that the maternal responsiveness measure will be based on a videotape segment. Could the child's language in this segment be an outcome? Response: In line with the reviewer and our logic model/ theory of change, we consider both the parent and educator outcome measures as mediators of change in the child outcomes. In our pilot trial we were unable to show significant change in our parent group and did not have a sufficient number of settings to explore the impact of potential changes in the preschool environment. Despite this, the intervention had a large effect on the participating children. However, we will add an exploratory set of models to the statistical analysis plan aimed at evaluating heterogeneity in treatment effects on child outcomes as a function of parent and educator outcomes. In addition, parents and teachers will be completing their own separate fidelity checks and 20% of the intervention sessions will also be coded for fidelity against the manual. The videotape segment is intended to capture the use of language promoting strategies used by parents, is a very short sample, and subject to significant variability due to differences in parental scaffolding. As such we would be concerned that it would not yield reliable MLU estimates due to the need for a considerable number of turns for such reliability. Also given that parents differ in their communication style, which affects the amount of language used by a child, this could be a confounding variable if we were to use the videos as estimates of language ability. Secondary child outcomes are weak. They rely on parent reports and are not sensitive to advances, but rather child weaknesses. No educator ratings are planned. Why not use a functional measure, such as the Vineland. Alternatively, the investigators could code child language from the MRBC videos. Response: We are capturing changes in child language through our primary outcomes measures, a standardized composite language measure (the PLS- 5) and a functional measure (the FOCUS- 34). Changes in parent behaviour are captured through the MRBCS, - an observation schedule shown to capture key characteristics associated with language growth over time (Down et al., 2015; Levickis et al., 2014; Smith et al., 2019) . The secondary outcome measures are as the reviewer suggests parent proxy measures, however literature suggests that parental measures are considered reliable and with acceptable concurrent validity (Feldman et al., 2005). The CLASS secondary outcome measure is a reliable measure which will allow us to assess change in the quality of interactions between teachers and students in the classroom, this is an aspect of our logic model which we deem important to capture. The Vineland is a measure of overall cognition rather than one that focuses specifically on language. We have not included educator ratings of children, as the staff working with children are not always consistent and they are working with large groups of children, only some of which are included in the evaluation. We do not want them to focus their attention/prioritise those in the evaluation over and above those who are not. Consider dropping the health-related quality-of-life measure as it has no relation to the intervention. Response – We agree that the HRQL measures are not ideal and may not be sensitive to the changes that we expect as a result of our intervention, this was the case in our pilot trial. However, our pilot trial assessments took place over a short time period and it is not recommended to complete these measures over a period shorter than a year. Improvement in language outcomes are associated with overall well-being and these HRQL measures do ask about communication, which is at the core of our intervention. We do not have other measures at our disposal that can generate QALYs and are therefore suitable for a primary cost effectiveness analysis. Rethink the economic analyses based on QALYs and HRQOL. Response - We have given these measures considerable thought and in discussion with our health economist had decided to include them as they are not onerous to complete and there are currently no better alternatives. We have however also included the FOCUS – 34 as our functional measure and the PLS-5 scores will be used in our secondary cost effectiveness analysis. Our pilot trial included a value of information analysis, and indicated that there was value in collecting further information in a large scale trial. The randomization of sites scheme. The investigators have not discussed the implications if a site that participated in Round 1 of the intervention is randomized to be control in Round 2. Isn’t it likely that those trained educators will continue to use what they have learned in the next round? What about if classes contain siblings of previous participants? Response - Round 2 will involve the recruitment of 4 additional sites (in different areas) and will have no relationship with the sites recruited in round 1. Down, K., Levickis, P., Hudson, S., Nicholls, R. and Wake, M. (2015), Measuring maternal responsiveness. Child Care Health Dev, 41: 329-333. https://doi.org/10.1111/cch.12174 Feldman HM, Dale PS, Campbell TF, Colborn DK, Kurs-Lasky M, Rockette HE, Paradise JL. Concurrent and predictive validity of parent reports of child language at ages 2 and 3 years. Child Dev. 2005 Jul-Aug;76(4):856-68. doi: 10.1111/j.1467-8624.2005.00882.x. PMID: 16026501; PMCID: PMC1350485. Levickis, Penny PhD *,†,‡ ; Reilly, Sheena PhD *,‡ ; Girolametto, Luigi PhD § ; Ukoumunne, Obioha C. PhD ‖ ; Wake, Melissa MD *,†,‡ . Maternal Behaviors Promoting Language Acquisition in Slow-to-Talk Toddlers: Prospective Community-based Study. Journal of Developmental & Behavioral Pediatrics 35(4):p 274-281, May 2014. | DOI: 10.1097/DBP.0000000000000056 Smith, J., Levickis, P., Eadie, T., Bretherton, L., Conway, L., & Goldfeld, S. (2019). Associations between early maternal behaviours and child language at 36 months in a cohort experiencing adversity. International journal of language & communication disorders , 54 (1), 110–122. https://doi.org/10.1111/1460-6984.12435 Competing Interests: None Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 12 Dec 2024 Pauline Frizelle , Department of Speech and Hearing Sciences, School of Clinical Therapies, University College Cork, Cork, Ireland 12 Dec 2024 Author Response We thank the reviewer for her positive evaluation of the protocol, and for the suggestions she has made to improve it. We document here how we have responded to each ... Continue reading We thank the reviewer for her positive evaluation of the protocol, and for the suggestions she has made to improve it. We document here how we have responded to each point. A point of clarification - The reviewer notes that participants will be targeted for recruitment from 4 Community Healthcare Organizations (CHOs) based on level of social disadvantage using a deprivation index. Participants will be recruited from 8 Community Healthcare Organizations (4 each year). Narrow the age range of participants. Infants less than one and children over about 4 need different types of language input than toddlers and young preschoolers. Response - The reviewer notes that it is concerning that child participants span a very broad age range i.e. 0-6. For clarification, the overall Happy Talk programme provides services for children 0-6 years, but this evaluation is focussed on the preschool programme only, which ranges from 2;10 months to a maximum of 6 years. However the majority of children fall within the 3 – 5 year age range. Engage parents in developing their intervention. Check on their ability to attend 12 1-hour sessions. When in the course of the program will they be completed? There is no discussion about the 12 1-hour sessions. Are they in person? Online? Response – This intervention has been implemented in one area of Ireland (to over 80 settings) for in excess of 11 years. The feasibility of the programme with parents living in socially disadvantaged areas has long been established. Feedback from parents and early years educators has been embedded in the programme since it was first developed. We realise that there will always be variability in parental attendance particularly when a programme is not yet established in an area. We had specified that the 12 1 hours sessions took place in 4 week blocks, 1 between September and December, 1 between January and March and 1 between April and June. We have clarified that they are in person. Consider the secondary measures as fidelity checks on parents and educators and adjust the statistical analyses accordingly. Rather than conceptualizing these measures as outcomes, they could be conceptualized as fidelity checks on the parents and teachers. Then changes in them could be considered mediators of change in the child outcomes. If parents or teachers are not changing as a function of the training, it is unlikely that the intervention will be successful. Note that the maternal responsiveness measure will be based on a videotape segment. Could the child's language in this segment be an outcome? Response: In line with the reviewer and our logic model/ theory of change, we consider both the parent and educator outcome measures as mediators of change in the child outcomes. In our pilot trial we were unable to show significant change in our parent group and did not have a sufficient number of settings to explore the impact of potential changes in the preschool environment. Despite this, the intervention had a large effect on the participating children. However, we will add an exploratory set of models to the statistical analysis plan aimed at evaluating heterogeneity in treatment effects on child outcomes as a function of parent and educator outcomes. In addition, parents and teachers will be completing their own separate fidelity checks and 20% of the intervention sessions will also be coded for fidelity against the manual. The videotape segment is intended to capture the use of language promoting strategies used by parents, is a very short sample, and subject to significant variability due to differences in parental scaffolding. As such we would be concerned that it would not yield reliable MLU estimates due to the need for a considerable number of turns for such reliability. Also given that parents differ in their communication style, which affects the amount of language used by a child, this could be a confounding variable if we were to use the videos as estimates of language ability. Secondary child outcomes are weak. They rely on parent reports and are not sensitive to advances, but rather child weaknesses. No educator ratings are planned. Why not use a functional measure, such as the Vineland. Alternatively, the investigators could code child language from the MRBC videos. Response: We are capturing changes in child language through our primary outcomes measures, a standardized composite language measure (the PLS- 5) and a functional measure (the FOCUS- 34). Changes in parent behaviour are captured through the MRBCS, - an observation schedule shown to capture key characteristics associated with language growth over time (Down et al., 2015; Levickis et al., 2014; Smith et al., 2019) . The secondary outcome measures are as the reviewer suggests parent proxy measures, however literature suggests that parental measures are considered reliable and with acceptable concurrent validity (Feldman et al., 2005). The CLASS secondary outcome measure is a reliable measure which will allow us to assess change in the quality of interactions between teachers and students in the classroom, this is an aspect of our logic model which we deem important to capture. The Vineland is a measure of overall cognition rather than one that focuses specifically on language. We have not included educator ratings of children, as the staff working with children are not always consistent and they are working with large groups of children, only some of which are included in the evaluation. We do not want them to focus their attention/prioritise those in the evaluation over and above those who are not. Consider dropping the health-related quality-of-life measure as it has no relation to the intervention. Response – We agree that the HRQL measures are not ideal and may not be sensitive to the changes that we expect as a result of our intervention, this was the case in our pilot trial. However, our pilot trial assessments took place over a short time period and it is not recommended to complete these measures over a period shorter than a year. Improvement in language outcomes are associated with overall well-being and these HRQL measures do ask about communication, which is at the core of our intervention. We do not have other measures at our disposal that can generate QALYs and are therefore suitable for a primary cost effectiveness analysis. Rethink the economic analyses based on QALYs and HRQOL. Response - We have given these measures considerable thought and in discussion with our health economist had decided to include them as they are not onerous to complete and there are currently no better alternatives. We have however also included the FOCUS – 34 as our functional measure and the PLS-5 scores will be used in our secondary cost effectiveness analysis. Our pilot trial included a value of information analysis, and indicated that there was value in collecting further information in a large scale trial. The randomization of sites scheme. The investigators have not discussed the implications if a site that participated in Round 1 of the intervention is randomized to be control in Round 2. Isn’t it likely that those trained educators will continue to use what they have learned in the next round? What about if classes contain siblings of previous participants? Response - Round 2 will involve the recruitment of 4 additional sites (in different areas) and will have no relationship with the sites recruited in round 1. Down, K., Levickis, P., Hudson, S., Nicholls, R. and Wake, M. (2015), Measuring maternal responsiveness. Child Care Health Dev, 41: 329-333. https://doi.org/10.1111/cch.12174 Feldman HM, Dale PS, Campbell TF, Colborn DK, Kurs-Lasky M, Rockette HE, Paradise JL. Concurrent and predictive validity of parent reports of child language at ages 2 and 3 years. Child Dev. 2005 Jul-Aug;76(4):856-68. doi: 10.1111/j.1467-8624.2005.00882.x. PMID: 16026501; PMCID: PMC1350485. Levickis, Penny PhD *,†,‡ ; Reilly, Sheena PhD *,‡ ; Girolametto, Luigi PhD § ; Ukoumunne, Obioha C. PhD ‖ ; Wake, Melissa MD *,†,‡ . Maternal Behaviors Promoting Language Acquisition in Slow-to-Talk Toddlers: Prospective Community-based Study. Journal of Developmental & Behavioral Pediatrics 35(4):p 274-281, May 2014. | DOI: 10.1097/DBP.0000000000000056 Smith, J., Levickis, P., Eadie, T., Bretherton, L., Conway, L., & Goldfeld, S. (2019). Associations between early maternal behaviours and child language at 36 months in a cohort experiencing adversity. International journal of language & communication disorders , 54 (1), 110–122. https://doi.org/10.1111/1460-6984.12435 We thank the reviewer for her positive evaluation of the protocol, and for the suggestions she has made to improve it. We document here how we have responded to each point. A point of clarification - The reviewer notes that participants will be targeted for recruitment from 4 Community Healthcare Organizations (CHOs) based on level of social disadvantage using a deprivation index. Participants will be recruited from 8 Community Healthcare Organizations (4 each year). Narrow the age range of participants. Infants less than one and children over about 4 need different types of language input than toddlers and young preschoolers. Response - The reviewer notes that it is concerning that child participants span a very broad age range i.e. 0-6. For clarification, the overall Happy Talk programme provides services for children 0-6 years, but this evaluation is focussed on the preschool programme only, which ranges from 2;10 months to a maximum of 6 years. However the majority of children fall within the 3 – 5 year age range. Engage parents in developing their intervention. Check on their ability to attend 12 1-hour sessions. When in the course of the program will they be completed? There is no discussion about the 12 1-hour sessions. Are they in person? Online? Response – This intervention has been implemented in one area of Ireland (to over 80 settings) for in excess of 11 years. The feasibility of the programme with parents living in socially disadvantaged areas has long been established. Feedback from parents and early years educators has been embedded in the programme since it was first developed. We realise that there will always be variability in parental attendance particularly when a programme is not yet established in an area. We had specified that the 12 1 hours sessions took place in 4 week blocks, 1 between September and December, 1 between January and March and 1 between April and June. We have clarified that they are in person. Consider the secondary measures as fidelity checks on parents and educators and adjust the statistical analyses accordingly. Rather than conceptualizing these measures as outcomes, they could be conceptualized as fidelity checks on the parents and teachers. Then changes in them could be considered mediators of change in the child outcomes. If parents or teachers are not changing as a function of the training, it is unlikely that the intervention will be successful. Note that the maternal responsiveness measure will be based on a videotape segment. Could the child's language in this segment be an outcome? Response: In line with the reviewer and our logic model/ theory of change, we consider both the parent and educator outcome measures as mediators of change in the child outcomes. In our pilot trial we were unable to show significant change in our parent group and did not have a sufficient number of settings to explore the impact of potential changes in the preschool environment. Despite this, the intervention had a large effect on the participating children. However, we will add an exploratory set of models to the statistical analysis plan aimed at evaluating heterogeneity in treatment effects on child outcomes as a function of parent and educator outcomes. In addition, parents and teachers will be completing their own separate fidelity checks and 20% of the intervention sessions will also be coded for fidelity against the manual. The videotape segment is intended to capture the use of language promoting strategies used by parents, is a very short sample, and subject to significant variability due to differences in parental scaffolding. As such we would be concerned that it would not yield reliable MLU estimates due to the need for a considerable number of turns for such reliability. Also given that parents differ in their communication style, which affects the amount of language used by a child, this could be a confounding variable if we were to use the videos as estimates of language ability. Secondary child outcomes are weak. They rely on parent reports and are not sensitive to advances, but rather child weaknesses. No educator ratings are planned. Why not use a functional measure, such as the Vineland. Alternatively, the investigators could code child language from the MRBC videos. Response: We are capturing changes in child language through our primary outcomes measures, a standardized composite language measure (the PLS- 5) and a functional measure (the FOCUS- 34). Changes in parent behaviour are captured through the MRBCS, - an observation schedule shown to capture key characteristics associated with language growth over time (Down et al., 2015; Levickis et al., 2014; Smith et al., 2019) . The secondary outcome measures are as the reviewer suggests parent proxy measures, however literature suggests that parental measures are considered reliable and with acceptable concurrent validity (Feldman et al., 2005). The CLASS secondary outcome measure is a reliable measure which will allow us to assess change in the quality of interactions between teachers and students in the classroom, this is an aspect of our logic model which we deem important to capture. The Vineland is a measure of overall cognition rather than one that focuses specifically on language. We have not included educator ratings of children, as the staff working with children are not always consistent and they are working with large groups of children, only some of which are included in the evaluation. We do not want them to focus their attention/prioritise those in the evaluation over and above those who are not. Consider dropping the health-related quality-of-life measure as it has no relation to the intervention. Response – We agree that the HRQL measures are not ideal and may not be sensitive to the changes that we expect as a result of our intervention, this was the case in our pilot trial. However, our pilot trial assessments took place over a short time period and it is not recommended to complete these measures over a period shorter than a year. Improvement in language outcomes are associated with overall well-being and these HRQL measures do ask about communication, which is at the core of our intervention. We do not have other measures at our disposal that can generate QALYs and are therefore suitable for a primary cost effectiveness analysis. Rethink the economic analyses based on QALYs and HRQOL. Response - We have given these measures considerable thought and in discussion with our health economist had decided to include them as they are not onerous to complete and there are currently no better alternatives. We have however also included the FOCUS – 34 as our functional measure and the PLS-5 scores will be used in our secondary cost effectiveness analysis. Our pilot trial included a value of information analysis, and indicated that there was value in collecting further information in a large scale trial. The randomization of sites scheme. The investigators have not discussed the implications if a site that participated in Round 1 of the intervention is randomized to be control in Round 2. Isn’t it likely that those trained educators will continue to use what they have learned in the next round? What about if classes contain siblings of previous participants? Response - Round 2 will involve the recruitment of 4 additional sites (in different areas) and will have no relationship with the sites recruited in round 1. Down, K., Levickis, P., Hudson, S., Nicholls, R. and Wake, M. (2015), Measuring maternal responsiveness. Child Care Health Dev, 41: 329-333. https://doi.org/10.1111/cch.12174 Feldman HM, Dale PS, Campbell TF, Colborn DK, Kurs-Lasky M, Rockette HE, Paradise JL. Concurrent and predictive validity of parent reports of child language at ages 2 and 3 years. Child Dev. 2005 Jul-Aug;76(4):856-68. doi: 10.1111/j.1467-8624.2005.00882.x. PMID: 16026501; PMCID: PMC1350485. Levickis, Penny PhD *,†,‡ ; Reilly, Sheena PhD *,‡ ; Girolametto, Luigi PhD § ; Ukoumunne, Obioha C. PhD ‖ ; Wake, Melissa MD *,†,‡ . Maternal Behaviors Promoting Language Acquisition in Slow-to-Talk Toddlers: Prospective Community-based Study. Journal of Developmental & Behavioral Pediatrics 35(4):p 274-281, May 2014. | DOI: 10.1097/DBP.0000000000000056 Smith, J., Levickis, P., Eadie, T., Bretherton, L., Conway, L., & Goldfeld, S. (2019). Associations between early maternal behaviours and child language at 36 months in a cohort experiencing adversity. International journal of language & communication disorders , 54 (1), 110–122. https://doi.org/10.1111/1460-6984.12435 Competing Interests: None Close Report a concern COMMENT ON THIS REPORT Comments on this article Comments (0) Version 3 VERSION 3 PUBLISHED 08 Oct 2024 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 3 4 Version 3 (revision) 31 Jan 25 read read Version 2 (revision) 07 Dec 24 read read read Version 1 08 Oct 24 read Heidi Feldman , Stanford University, Stanford, USA Meredith L. Rowe , Harvard University, Cambridge, USA Nicola Botting , City University London, London, UK Naja Ferjan Ramirez , University of Washington, Seattle, USA Adeline Braverman , University of Washington Seattle, USA, USA; University of Washington (Ringgold ID: 7284), Seattle, USA Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Ramirez N et al. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 04 Feb 2025 | for Version 3 Naja Ferjan Ramirez , University of Washington, Seattle, USA Adeline Braverman , University of Washington Seattle, USA, USA; Linguistics, University of Washington (Ringgold ID: 7284), Seattle, Washington, USA 0 Views copyright © 2025 Ramirez N et al. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions I think the authors have adequately addressed our concerns/questions. Competing Interests No competing interests were disclosed. Reviewer Expertise Language acquisition in infancy and early childhood; Language intervention; Language input We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Ramirez NF and Braverman A. Peer Review Report For: Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.21956/hrbopenres.15461.r45226) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-65/v3#referee-response-45226 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Botting N. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 04 Feb 2025 | for Version 3 Nicola Botting , City University London, London, UK 0 Views copyright © 2025 Botting N. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Thank you for detailed responses to my comments. I am happy to approve version 3. Competing Interests No competing interests were disclosed. Reviewer Expertise Developmental Language Disorder & other forms of atypical language development I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Botting N. Peer Review Report For: Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.21956/hrbopenres.15461.r45223) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-65/v3#referee-response-45223 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Ramirez N et al. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 11 Jan 2025 | for Version 2 Naja Ferjan Ramirez , University of Washington, Seattle, USA Adeline Braverman , University of Washington Seattle, USA, USA; Linguistics, University of Washington (Ringgold ID: 7284), Seattle, Washington, USA 0 Views copyright © 2025 Ramirez N et al. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions This is a revised version of the narrative, and I think most of the issues have already been addressed. Overall, the study is well-designed and targets an important public health concern. We are pointing out some potential areas of improvement. 12 1-hr sessions attended by parents: This could be a challenge as it is quite intensive and requires a lot of time and effort. Parents are busy, and may not be able to attend all (or even most) sessions – this seems especially relevant given that families are low SES. How will the team make sure that parents attend the sessions? The narrative suggests that this intervention has already been implemented successfully in parts of Ireland. Is there any data to show that parents stayed engaged throughout the program? On a related note, were parents invited to help in the DESIGN of the intervention? Do we know that they find it (culturally) acceptable and doable/executable given their day-to-day lives? Not much is said about this in the narrative. The second research question asks whether Happy Talk “enhance[s] responsiveness and language-promoting behaviors in home and pre/school contexts.” The associated hypothesis is that intervention parents will have higher Maternal Responsive Behaviors Coding Scheme (MRBCS) scores. Is the MRBCS sensitive to “language-promoting behaviors” beyond those associated with responsiveness? The research question may need to be narrowed so that it is adequately addressed by this outcome measure, or the authors should clarify that responsiveness is the language-promoting behavior in question. Nothing is said about measuring “attendance” – i.e. are the effects of the intervention hypothesized to be weaker in those families who attend fewer sessions? Relatedly, what were the attendance/drop-out rates in previous iterations of the intervention? Inclusion of fathers: not much is said about this…in our experience, if fathers are just “invited”, they tend to not attend the sessions. Will there be an explicit effort to recruit and retain the fathers? Why (not)? OR – alternatively - if both parents attend in some cases, and only one parent attend in others, can there be supplemental hypotheses around whether one or both parents received the treatment? In the ‘Data Collection’ section, it is somewhat unclear what measures will be collected at the Baseline Assessment. Are all outcome measures included at this initial timepoint? How will the PLS-5 be scored by the second research assistant? Will these assessments be recorded? Preschool staff treatment – 4x 2.5-3 hours of staff training: similarly to parent training, do we know that the staff are eager and excited to undergo these trainings? What about the school administration? Will they be able to pull the teachers out of the classroom to give them the necessary time for training? On a related note, are teachers engaged in the design of the intervention? If so, what are their opinions of it? If not, they may find it challenging to implement. Child outcomes: most are parent/staff reports, which is a disadvantage, given that they’re being treated. One might hypothesize that the intervention will train the parents/staff to answer the questionnaires differently compared to the control group. I recommend that the team add child outcome language measures that are NOT questionnaire based. This was already noted by a previous reviewer. In their response, the authors cite work demonstrating the reliability and validity of parent report instruments, but this work focuses only on the MBCDI in a younger age range than the proposed sample and outside the context of parent-mediated intervention. In Figure 2, the use of multiple arrows leads the reader to believe that each bullet point is associated with another in the neighboring box. However, the bullet points do not always line up (in number and content). Consider reducing the number of arrows or clarifying the connections between the contents of each box. For the most part, there is sufficient detail of the methods provided to allow for replication. The hypotheses and the rationale, the subject numbers and characteristics are well described and make sense. The only thing that’s missing is the intervention “scripts”/ content/ manual – this is not shared, so one could not actually replicate the study as it is unclear what the parents / staff are actually told during the sessions. I am not sure if this is intentional. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Language acquisition in infancy and early childhood; Language intervention; Language input We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however we have significant reservations, as outlined above. reply Respond to this report Responses (1) Author Response 24 Jan 2025 Pauline Frizelle, Department of Speech and Hearing Sciences, School of Clinical Therapies, University College Cork, Cork, Ireland Many thanks for your valuable feedback, we have addressed each point in turn. 12 1-hr sessions attended by parents: This could be a challenge as it is quite intensive and requires a lot of time and effort. Parents are busy, and may not be able to attend all (or even most) sessions – this seems especially relevant given that families are low SES. How will the team make sure that parents attend the sessions? The narrative suggests that this intervention has already been implemented successfully in parts of Ireland. Is there any data to show that parents stayed engaged throughout the program? On a related note, were parents invited to help in the DESIGN of the intervention? Do we know that they find it (culturally) acceptable and doable/executable given their day-to-day lives? Not much is said about this in the narrative. Response: Happy Talk has been delivered in one part of Ireland for 12 years. The programme was originally developed by SLTs but the design has been adapted over the years based on feedback from parents and early years educators. We also measured feasibility and acceptability in a new area in our pilot trial (referenced within). As stated in response to reviewer 2, in areas where Happy Talk is well established there is very high attendance as other parents/educators have spoken so positively about the programme and parents have an expectation that this will be part of their child’s education. In new areas (as is the case here) attendance tends to increase as the programme progresses. Parents become more committed as their confidence increases, and children request their parents to be present in the classroom, as they enjoy this aspect of the programme. In any case, we take a conservative approach in using an intention to treat protocol, so that if a parent attends even one session they are considered to have received the intervention. The second research question asks whether Happy Talk “enhance[s] responsiveness and language-promoting behaviors in home and pre/school contexts.” The associated hypothesis is that intervention parents will have higher Maternal Responsive Behaviors Coding Scheme (MRBCS) scores. Is the MRBCS sensitive to “language-promoting behaviors” beyond those associated with responsiveness? The research question may need to be narrowed so that it is adequately addressed by this outcome measure, or the authors should clarify that responsiveness is the language-promoting behavior in question. Response: We have clarified that responsiveness is the language-promoting behavior in question. Nothing is said about measuring “attendance” – i.e. are the effects of the intervention hypothesized to be weaker in those families who attend fewer sessions? Relatedly, what were the attendance/drop-out rates in previous iterations of the intervention? Response: We have clarified that attendance will be measured throughout both iterations of the programme. As stated above, attendance tends to increase as parents become more engaged with the programme. We have reported the attendance rates and attrition in our published pilot trial. Inclusion of fathers: not much is said about this…in our experience, if fathers are just “invited”, they tend to not attend the sessions. Will there be an explicit effort to recruit and retain the fathers? Why (not)? OR – alternatively - if both parents attend in some cases, and only one parent attend in others, can there be supplemental hypotheses around whether one or both parents received the treatment? Response: Given the demands of the programme the reviewer has highlighted, we encourage one parent/caregiver to attend, whichever places the smallest burden on the family. In our experience this is most often the mother but fathers and grandparents have also attended. If there are a sufficient number of cases where individual parents attend different sessions or both parents attend we will examine any potential effects statistically. However, this has not been our experience in the past. We request that the same person attend for baseline and end of programme measures. In the ‘Data Collection’ section, it is somewhat unclear what measures will be collected at the Baseline Assessment. Are all outcome measures included at this initial timepoint? Response : We have clarified that all outcome measures are included at the initial stages. How will the PLS-5 be scored by the second research assistant? Will these assessments be recorded? Response: No, these are not recorded. The 2 nd researcher will check that the scores have been added correctly, and converted accurately into standard scores. We have clarified this in the text. Preschool staff treatment – 4x 2.5-3 hours of staff training: similarly to parent training, do we know that the staff are eager and excited to undergo these trainings? What about the school administration? Will they be able to pull the teachers out of the classroom to give them the necessary time for training? On a related note, are teachers engaged in the design of the intervention? If so, what are their opinions of it? If not, they may find it challenging to implement. Response : In keeping with my response with respect to parents, teachers have implemented the programme in one area of Ireland for many years, and have reported it to be feasible and acceptable – we have noted this in the text. They have also had input into the programme as it was developing over many years. We carry out the sessions in the classroom at a time that is convenient for the teachers. In addition, all teachers are required to engage with continuous professional development, the Happy Talk training fulfils that need. Child outcomes: most are parent/staff reports, which is a disadvantage, given that they’re being treated. One might hypothesize that the intervention will train the parents/staff to answer the questionnaires differently compared to the control group. I recommend that the team add child outcome language measures that are NOT questionnaire based. This was already noted by a previous reviewer. In their response, the authors cite work demonstrating the reliability and validity of parent report instruments, but this work focuses only on the MBCDI in a younger age range than the proposed sample and outside the context of parent-mediated intervention. Response : We have included the PLS-5 which is a standardized language measure which provides a receptive, expressive and composite language score. In Figure 2, the use of multiple arrows leads the reader to believe that each bullet point is associated with another in the neighboring box. However, the bullet points do not always line up (in number and content). Consider reducing the number of arrows or clarifying the connections between the contents of each box. Response: Where arrows don’t directly align they are intended to refer to more than one component within a given box, we have clarified this in the text. For the most part, there is sufficient detail of the methods provided to allow for replication. The hypotheses and the rationale, the subject numbers and characteristics are well described and make sense. The only thing that’s missing is the intervention “scripts”/ content/ manual – this is not shared, so one could not actually replicate the study as it is unclear what the parents / staff are actually told during the sessions. I am not sure if this is intentional. Response: We cannot make the manual publicly available due to copyright reasons. Those who are interested in getting further information, or adapting the intervention to their context are welcome to get in touch with the first author. View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Ramirez NF and Braverman A. Peer Review Report For: Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.21956/hrbopenres.15422.r44222) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-65/v2#referee-response-44222 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Botting N. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 08 Jan 2025 | for Version 2 Nicola Botting , City University London, London, UK 0 Views copyright © 2025 Botting N. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions This is a very well constructed and clear protocol for a large scale intervention trial using the Happy Talk programme. There is substantial need for the evaluation of early years language interventions such as this, and this team is ideally placed to carry out such research. The previous 2 reviewers have given comprehensive and insightful comments, many of which have already been responded to by the authors, therefore my observations are brief and minor. Some of them echo other points already made. 1. RQ1: It might be helpful for readers to include 'compared to usual care' in RQ1. This is implied, but at the moment leaves the possibility that positive within-group change for the intervention group alone could answer this question (which is not the authors' intention). 2. Recruitment: Opt-in consent is being used. It would be useful to identify and detail any strategies for monitoring/ensuring that these sign ups represent low SES groups, as even within schools in disadvantaged areas, participation from some groups is difficult to attain. Would opt-out consent be considered if recruitment shows bias? Have the authors considered adding the option for a Qualtrics (or similar) link to consent, which we are finding useful in recruiting families where bits of paper get lost (I acknowledge this method has its own inherent biases, but maybe a combination?). Under Randomisation, it could be made clearer that the families are randomly selected *from consenting families*. The inclusion of families with additional languages is important, but it is not clear to me how the parent English level will be assessed. A small point but it is probably best to avoid the term 'subjects' even in a trial? 3. Data management: I have no doubt that this team are thoroughly conversant in data management, but for readers and replicability more detail about how data sharing (agreements), and transit across sites (and countries) will be securely achieved would be welcome. It would be useful to know who has overall responsibility for data governance and data backups etc. 4. Training workshops: It was not clear to me how many people are at each workshop or included in the weekly video-conference support sessions. This detail seems important in terms of attendance bias, and success of the programme, and is needed for replicability. It would be useful to specify whether by 'recorded' you mean video or audio only. How will you deal with participants who do not give consent to recording or to other people in the background? 5. Assessment measures: In line with the other reviews, I am not sure about the CLASS and wondered whether authors had considered the CsC developed by Dockrell et al. for Better Communication? Will the reliability measures taken by an additional person occur at the same time or on a different day? In addition I wondered whether the FOCUS-34 has a reference? A couple of example questions might be useful here. For the MRBCS, I think this should read 'a total number of occurrences for each of four parental behaviours'? If not, more explanation is needed. 6. Economic assessment: I agree with other reviewers that it is confusing to use only the HRQoL measure for this stage of the project, especially when this didn't change on pilot trials. I see in the author response that the PLS-5 and FOCUS-34 are now included in a secondary economic analysis, but cannot find this detail in the protocol itself. Overall, this is a comprehensive and impressive protocol which has potential to make substantial impact and contribution. The minor suggestions above are mainly intended to enhance replicability and to increase usefulness even further. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Developmental Language Disorder & other forms of atypical language development I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (1) Author Response 31 Jan 2025 Pauline Frizelle, Department of Speech and Hearing Sciences, School of Clinical Therapies, University College Cork, Cork, Ireland Thank you for taking the time to give your valuable feedback. 1. RQ1: It might be helpful for readers to include 'compared to usual care' in RQ1. This is implied, but at the moment leaves the possibility that positive within-group change for the intervention group alone could answer this question (which is not the authors' intention). Response : We have added the clarification to RQ1 - that the intervention is being compared to usual care 2. Recruitment: Opt-in consent is being used. It would be useful to identify and detail any strategies for monitoring/ensuring that these sign ups represent low SES groups, as even within schools in disadvantaged areas, participation from some groups is difficult to attain. Would opt-out consent be considered if recruitment shows bias? Have the authors considered adding the option for a Qualtrics (or similar) link to consent, which we are finding useful in recruiting families where bits of paper get lost (I acknowledge this method has its own inherent biases, but maybe a combination?). Under Randomisation, it could be made clearer that the families are randomly selected *from consenting families*. The inclusion of families with additional languages is important, but it is not clear to me how the parent English level will be assessed. A small point but it is probably best to avoid the term 'subjects' even in a trial? Response: In relation to the profile of those who sign up, we appreciate that there will be variability in terms of levels of disadvantage. However, we will note these individual differences in the collection of our demographic data. As stated in response to another reviewer we acknowledge that the same variation will exist within the control settings and therefore should not be a confounding variable. In addition to the initial information session, our consent process is being facilitated by the pre/school staff who are available to read through the trial information and consent forms and answer any questions that potential participants might have when dropping and collecting their children. We appreciate the suggestion re Qualtrics but this would require access to a computer and feedback from pre/school staff is that they prefer to support the process in an informal way so that parents don’t feel under pressure to participate in the evaluation. There are large numbers of children receiving the intervention who are not part of the evaluation and if we were to engage in an opt out process, we would not have the capacity to assess them all in the restricted time frame. We have clarified that families are randomly selected from consenting families. As the reviewer rightly points out we are not actively assessing parents level of English and we have amended the text to remove the requirement of level B2. Parents will be asked if they are confident to complete the outcome measures without the need for an interpreter. We have replaced the term subjects, the use of which was an oversight on our part. 3. Data management: I have no doubt that this team are thoroughly conversant in data management, but for readers and replicability more detail about how data sharing (agreements), and transit across sites (and countries) will be securely achieved would be welcome. It would be useful to know who has overall responsibility for data governance and data backups etc. Response: This is a national study and therefore there is no data sharing between countries. We have made our data management plan available on OSF ( https://osf.io/ns7u5/ ) to address the reviewers point. 4. Training workshops: It was not clear to me how many people are at each workshop or included in the weekly video-conference support sessions. This detail seems important in terms of attendance bias, and success of the programme, and is needed for replicability. It would be useful to specify whether by 'recorded' you mean video or audio only. How will you deal with participants who do not give consent to recording or to other people in the background? Response: The workshops are for the pre/school staff and will be attended by the number who are participating in the intervention in a given pre/school, this varies from setting to setting and goes beyond those who are included in the trial. For example in some preschools there may be 3 staff (working in one room) where as others may have 5 across two rooms. We have clarified this in the text. We have specified that we will audio record the sessions, the therapist will wear a microphone, set to capture his/her input only. We appreciate that some child audio may be picked up in the distance but they will not be identifiable; we will not transcribe it (if audible); and we will not be using it in any way to measure interventionist fidelity. We have clarified that there will be 4 SLTs each year (8 in total) who will be attending the video-conference calls. 5. Assessment measures: In line with the other reviews, I am not sure about the CLASS and wondered whether authors had considered the CsC developed by Dockrell et al. for Better Communication? Will the reliability measures taken by an additional person occur at the same time or on a different day? In addition I wondered whether the FOCUS-34 has a reference? A couple of example questions might be useful here. For the MRBCS, I think this should read 'a total number of occurrences for each of four parental behaviours'? If not, more explanation is needed. Response: We used the CsC in our pilot trial and although we were not able to complete statistical analyses (due to a small number of settings) our observations of the data suggested that it was not sensitive to the expected changes. Empirical literature suggests that the CLASS is a reliable tool across a number of languages (Hamre et al., 2008; Stuck et al., 2016; Virtanen et al., 2017) and we expect sensitivity to a number of areas in which we aim to effect change - in particular Concept development, Quality of feedback and Language modelling . In addition, colleagues who have significant experience researching in the area of professional development of early years educators, have found the CLASS to be a sensitive measure (Eadie et. al.,). Because the CLASS is completed live, reliability checking will involve score checking only. However, to be deemed a reliable coder, all CLASS administrators are required to score within 1 point of master codes on 80% of all codes given in the training videos. We have added some references for the FOCUS-34, as well as some sample questions. We have reworded in relation to the MRBCS. 6. Economic assessment: I agree with other reviewers that it is confusing to use only the HRQoL measure for this stage of the project, especially when this didn't change on pilot trials. I see in the author response that the PLS-5 and FOCUS-34 are now included in a secondary economic analysis, but cannot find this detail in the protocol itself. Response: We have adapted the text to make the secondary (economic) analysis more explicit, specifying these two measures. View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Botting N. Peer Review Report For: Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.21956/hrbopenres.15422.r43956) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-65/v2#referee-response-43956 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2025 Rowe M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 06 Jan 2025 | for Version 2 Meredith L. Rowe , Harvard University, Cambridge, USA 0 Views copyright © 2025 Rowe M. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Review of Study Protocol: “Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial” for HRB Open Research. This is a proposed RCT to examine effects of the Happy Talk intervention for preschool educators and parents on preschool children’s language outcomes in Ireland. The literature review does a good job of making the case for the need (the low language skills in areas of social disadvantage) and for the approach (targeting teachers and parents) in this effectiveness trial in the community. Is the rationale for, and objectives of, the study clearly described? Yes, for the most part, the research questions are clear and follow from the literature review. My only question is about RQ4 and any hypotheses regarding the specific program features or contextual factors. If there are no specific hypotheses here, and if this RQ is under-powered statistically, the authors might list this as an “exploratory analysis”. Is the study design appropriate for the research question? The longitudinal cluster randomized design is appropriate. I have a few small questions about the methods where more information could be provided. -are the randomly chosen 12 participants all going to be from lower-SES backgrounds? This seems important given the rationale -are the parents compensated for attending the sessions? What is the motivation for them and feasibility of them showing up based on prior work with this intervention? I see they are compensated when the child gets tested, but also for their own participation or do they opt in without this added incentive? -it might be important to see if the children in the classrooms of “communication champions” do better than those in other treatment classrooms -I wonder if a more nuanced measure of classroom language would be helpful in addition to the CLASS. That is, if is it possible to audiotape a short “circle time” session for each participating teacher during the CLASS observation then this segment could be coded for teacher and classroom language use. For example, how many questions the teacher asks, how many children contribute to conversations, how extended the conversations are, etc. This would be similar to the MRBCS but in the classroom context. This is understandably a fair amount of work to record, and potentially transcribe and code, but it may result in a lot more variability in relevant measures than the CLASS and also in some insights as to the specific mechanisms of effects. -Also, I would suggest potentially coding the child speech in the MRBCS samples as an additional measure of child language/vocabulary. *these last two comments are based on the fact that many parent and preschool interventions have a hard time ‘moving the needle’ on standardized tests but are more likely to show effects on the day-to-day practices that are promoted. I worry that the vast majority of the measures here are more global and standardized and more subtle effects might be missed. If coding videos is too time-consuming, maybe something like the Language Use Inventory (McNeill) that can be filled out by the teacher and the parent (of course there are bias issues here because of parent/teacher reporting). Are sufficient details of the methods provided to allow replication by others? Yes, it appears so as long as the intervention itself is publicly available. Are the datasets clearly presented in a useable and accessible format? Data analysis and monitoring plans seem appropriate. -I am wondering if some children will potentially have a teacher who participated in the intervention 2 years and others just have 1 teacher and then a non-intervention teacher for the 1- year follow up? If this is the case, this factor needs to be controlled/examined or potentially manipulated in classroom placement for the children randomly chosen to participate. -the economic analysis is a strength of this study. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Language development, parenting, parent interventions, early childhood I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (1) Author Response 24 Jan 2025 Pauline Frizelle, Department of Speech and Hearing Sciences, School of Clinical Therapies, University College Cork, Cork, Ireland Many thanks for your valuable feedback - we have addressed each point in turn Are the randomly chosen 12 participants all going to be from lower-SES backgrounds? This seems important given the rationale Response: The profile of all settings is that they are in significantly disadvantaged areas and are designated DEIS pre/schools in Ireland (Delivering Equality and Opportunity in schools). We appreciate that there will be different degrees of disadvantage within a given setting, however, we will note these individual differences in the collection of our demographic data. We acknowledge that the same variation will exist within the control settings and therefore should not be a confounding variable. Are the parents compensated for attending the sessions? What is the motivation for them and feasibility of them showing up based on prior work with this intervention? I see they are compensated when the child gets tested, but also for their own participation or do they opt in without this added incentive? Response: Parents are not compensated for attending the sessions, they opt in without additional incentives. In areas where Happy Talk is well established there is very high attendance as other parents/educators have spoken so positively about the programme and parents have an expectation that this will be part of their child’s education. In new areas (as is the case here) attendance tends to increase as the programme progresses. Parents become more committed as their confidence increases, and children request their parents to be present in the classroom, as they enjoy this aspect of the programme. it might be important to see if the children in the classrooms of “communication champions” do better than those in other treatment classrooms Response: There will be a communication champion in all rooms in which there are children attending Happy Talk. We have clarified this in the text. I wonder if a more nuanced measure of classroom language would be helpful in addition to the CLASS. That is, if is it possible to audiotape a short “circle time” session for each participating teacher during the CLASS observation then this segment could be coded for teacher and classroom language use. For example, how many questions the teacher asks, how many children contribute to conversations, how extended the conversations are, etc. This would be similar to the MRBCS but in the classroom context. This is understandably a fair amount of work to record, and potentially transcribe and code, but it may result in a lot more variability in relevant measures than the CLASS and also in some insights as to the specific mechanisms of effects. -Also, I would suggest potentially coding the child speech in the MRBCS samples as an additional measure of child language/vocabulary. Response: We appreciate the reviewers comments with respect to capturing the day to day changes in child language and interaction. We are using the FOCUS-34 with the aim of capturing these functional changes at home and in school. Unfortunately time constraints and resources prevent us from recording and coding sessions in the classroom. There are also ethical issues as we would be actively recording children who have consented to receiving Happy Talk but have not consented to participate in the evaluation. We are cognisant of the burden of evaluation on families and for this reason, do not want to introduce any further outcome measures. We are reluctant to use the language produced during the MRBCS as a measure of child language /vocabulary for the reasons outlined in response to reviewer 1. Specifically, the videotape segment is intended to capture the use of language promoting strategies used by parents, is a very short sample, and subject to significant variability due to differences in parental scaffolding. As such we would be concerned that it would not yield reliable MLU estimates due to the need for a considerable number of turns for such reliability. Also given that parents differ in their communication style, which affects the amount of language used by a child, this could be a confounding variable if we were to use the videos as estimates of language ability. *these last two comments are based on the fact that many parent and preschool interventions have a hard time ‘moving the needle’ on standardized tests but are more likely to show effects on the day-to-day practices that are promoted. I worry that the vast majority of the measures here are more global and standardized and more subtle effects might be missed. If coding videos is too time-consuming, maybe something like the Language Use Inventory (McNeill) that can be filled out by the teacher and the parent (of course there are bias issues here because of parent/teacher reporting). I am wondering if some children will potentially have a teacher who participated in the intervention 2 years and others just have 1 teacher and then a non-intervention teacher for the 1- year follow up? If this is the case, this factor needs to be controlled/examined or potentially manipulated in classroom placement for the children randomly chosen to participate. Response: All educators and children will only participate in the intervention for one year. However, it is possible that some children will progress from an intervention preschool to a school that also participated in the intervention and where the teacher was trained in the Happy Talk programme. We will control for this factor. View more View less Competing Interests No competing interests were disclosed. reply Respond Report a concern Rowe ML. Peer Review Report For: Evaluating a targeted selective speech, language, and communication intervention at scale – Protocol for the Happy Talk cluster randomised controlled trial. [version 3; peer review: 3 approved, 1 approved with reservations] . HRB Open Res 2025, 7 :65 ( https://doi.org/10.21956/hrbopenres.15422.r43949) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://hrbopenresearch.org/articles/7-65/v2#referee-response-43949 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2024 Feldman H. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 25 Nov 2024 | for Version 1 Heidi Feldman , Stanford University, Stanford, California, USA 0 Views copyright © 2024 Feldman H. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Background: Social disadvantage is associated with delays and disorders in language development. Previous studies have found that parent- or school-language enrichment programs are associated with slight to modest gains in child language outcomes. This study protocol combines both parent and school language enrichment in an effort to maximize the positive impact. Study design: The proposed study is a large scale cluster randomised trial of a 12-week manualised intervention delivered in pre/school settings serving socially disadvantaged communities, in Ireland. 72 clusters receive the intervention (12 participants per cluster). Parents and pre/school staff engage in group training and coaching in the form of 12 1-hour sessions for parents and four staff workshops for educators, over the course of the 8-month pre/school year. Is the rationale for, and objectives of, the study clearly described? The study rests on reliable observations that children from disadvantaged backgrounds have disproportionately higher rates of early and persistent language disorders than children from advantaged backgrounds. Language disorders predict important impacts for educational and occupational outcomes. The scope of this problem makes addressing language delay in poor communities an appropriate public health target. Further, given the high prevalence, a “tier 1” intervention, offered universally and preventatively, is highly appropriate. Previous linguistic and auditory intervention efforts directed to preschool educators have yielded variable findings and, at best, improvements with only modest effect sizes. Professional literacy interventions have been somewhat better for reading outcomes with little generalization to language. Similarly, preventive parent-directed interventions are also associated with small to moderate effect sizes. Based on this review, the investigators plan to provide intervention in more than a single environment, aimed at both home and school. Pilot data from Happy Talk in a single community of Ireland are promising, though other studies show no additional benefit. The questions and hypotheses are clear and comprehensive. Is the study design appropriate for the research question? The study is a cluster-randomized controlled trial taking place over three years. The intervention period is 8 months with immediate and delayed follow-up. This design is appropriate and feasible as an effectiveness tiral. Participants will be targeted for recruitment from 4 Community Healthcare Organizations based on level of social disadvantage using a deprivation index. These decisions are appropriate. Exclusion criteria are reasonable. The intervention is a manualized training and support programme delivered by Speech-Language Therapists (SLTs) to parents and early childhood educators. One concerning feature about the protocol is that the child participants are aged 0-6. This broad age range is problematic because the parent coaching for a 5–6-year-old would be exceedingly different from the appropriate strategies for a 1-2 year old. Limiting the intervention to 18 or 24 months of age to 36 months of age might be a better test of the protocol. Another potentially concerning feature is that the parent intervention component requires 12 1-hour sessions in 4-week blocks and in 2 additional 30-minute units over the school year. The investigators offer no rationale for this schedule. There is no mention of engaging potential participants in the development of the curriculum and specifically in the duration or timing of these sessions. The investigators plan a 2–3-week engagement phase with each school to build relationships, but parents are not included. The 30 minute segments are in person at the center with direct coaching with parent and child. When in the course of the program will they be completed? There is no discussion about the 12 1-hour sessions. Are they in person? Online? Does this schedule work for working and busy parents? There is also no discussion about the parents’ adherence to the plan. The outcome measures mention maternal responsiveness. Can fathers or other caregivers participate? The Happy Talk intervention will be compared to treatment as usual (TAU). This decision is very reasonable. The primary child outcome measures are the Pre-School Language Scales, 5 th edition and Focus on Outcomes of Communication Under 6, which is a parent report measure. The use of a parent-report measure introduces potential bias because the intervention targets parents. The secondary child measures, the PedsQL asks only about communication problems and is therefore likely to be highly insensitive in this setting. The other secondary outcome, the Child Health Utility Instrument is yet another caregiver-completed questionnaire and has nothing to do with the interventions being offered. Why should quality of life change? Note that the educators are not providing any ratings as outcome measures. Other potential ratings, such as a functional measure (ABBAS or Vineland) could be considered and these measures can be completed by parents and teachers.. There are two additional secondary measures—the Maternal Responsive Behavior Coding scheme and the Classroom Assessment Scoring System. Are fathers also invited to parent sessions? Why use a maternal measure? Rather than conceptualizing these measures as outcomes, they could be conceptualized as fidelity checks on the parents and teachers. Then changes in them could be considered mediators of change in the child outcomes. If parents or teachers are not changing as a function of the training, it is unlikely that the intervention will be successful. Note that the maternal responsiveness measure will be based on a videotape segment. Could the child's language in this segment be an outcome? Power analyses and the intention to treat rationale are well described. There is no rationale for the HRQoL in the economic analyses. Why should this assessment be sensitive to language interventions? Another potential program is the randomization of sites scheme. The investigators have not discussed the implications if a site that participated in Round 1 of the intervention is randomized to be control in Round 2. Isn’t it likely that those trained educators will continue to use what they have learned in the next round? What about if classes contain siblings of previous participants? Economic analyses are planned. The primary measures will be the standardised Health Related Quality of Life (HRQoL) questionnaires pre-, post- and at 12 months follow-up. HRQoL measures enable the calculation of Quality Adjusted Life Years (QALYs) as well as an investigation of the sensitivity of these measures with children. The investigators are wary of the plan. It is unclear how QALYs relate to the improvement in language skills anticipated in this trial. Could other methods be used, such as functional assessment (what is the value of increasing a child’s standard score on a functional measure in terms of later outcomes?) Are sufficient details of the methods provided to allow replication by others? The protocol is very detailed. The curricula are not included but other than that, the study is reproducible. Are the datasets clearly presented in a useable and accessible format? Not applicable. In summary, this ambitious trial may have important public health implications for disadvantaged children in Ireland and beyond. The study could be strengthened with adjustments in the planned methods: Narrow the age range of participants. Infants less than one and children over about 4 need different types of language input than toddlers and young preschoolers. Engage parents in developing their intervention. Check on their ability to attend 12 1-hour sessions. Consider the secondary measures as fidelity checks on parents and educators and adjust the statistical analyses accordingly. Secondary child outcomes are weak. They rely on parent reports and are not sensitive to advances, but rather child weaknesses. No educator ratings are planned. Why not use a functional measure, such as the Vineland. Alternatively, the investigators could code child language from the MRBC videos. Consider dropping the health-related quality-of-life measure as it has no relation to the intervention. Rethink the economic analyses based on QALYs and HRQOL. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise language development, developmental disabilities, pediatrics, developmental neuroscience I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (1) Author Response 12 Dec 2024 Pauline Frizelle, Department of Speech and Hearing Sciences, School of Clinical Therapies, University College Cork, Cork, Ireland We thank the reviewer for her positive evaluation of the protocol, and for the suggestions she has made to improve it. We document here how we have responded to each point. A point of clarification - The reviewer notes that participants will be targeted for recruitment from 4 Community Healthcare Organizations (CHOs) based on level of social disadvantage using a deprivation index. Participants will be recruited from 8 Community Healthcare Organizations (4 each year). Narrow the age range of participants. Infants less than one and children over about 4 need different types of language input than toddlers and young preschoolers. Response - The reviewer notes that it is concerning that child participants span a very broad age range i.e. 0-6. For clarification, the overall Happy Talk programme provides services for children 0-6 years, but this evaluation is focussed on the preschool programme only, which ranges from 2;10 months to a maximum of 6 years. However the majority of children fall within the 3 – 5 year age range. Engage parents in developing their intervention. Check on their ability to attend 12 1-hour sessions. When in the course of the program will they be completed? There is no discussion about the 12 1-hour sessions. Are they in person? Online? Response – This intervention has been implemented in one area of Ireland (to over 80 settings) for in excess of 11 years. The feasibility of the programme with parents living in socially disadvantaged areas has long been established. Feedback from parents and early years educators has been embedded in the programme since it was first developed. We realise that there will always be variability in parental attendance particularly when a programme is not yet established in an area. We had specified that the 12 1 hours sessions took place in 4 week blocks, 1 between September and December, 1 between January and March and 1 between April and June. We have clarified that they are in person. Consider the secondary measures as fidelity checks on parents and educators and adjust the statistical analyses accordingly. Rather than conceptualizing these measures as outcomes, they could be conceptualized as fidelity checks on the parents and teachers. Then changes in them could be considered mediators of change in the child outcomes. If parents or teachers are not changing as a function of the training, it is unlikely that the intervention will be successful. Note that the maternal responsiveness measure will be based on a videotape segment. Could the child's language in this segment be an outcome? Response: In line with the reviewer and our logic model/ theory of change, we consider both the parent and educator outcome measures as mediators of change in the child outcomes. In our pilot trial we were unable to show significant change in our parent group and did not have a sufficient number of settings to explore the impact of potential changes in the preschool environment. Despite this, the intervention had a large effect on the participating children. However, we will add an exploratory set of models to the statistical analysis plan aimed at evaluating heterogeneity in treatment effects on child outcomes as a function of parent and educator outcomes. In addition, parents and teachers will be completing their own separate fidelity checks and 20% of the intervention sessions will also be coded for fidelity against the manual. The videotape segment is intended to capture the use of language promoting strategies used by parents, is a very short sample, and subject to significant variability due to differences in parental scaffolding. As such we would be concerned that it would not yield reliable MLU estimates due to the need for a considerable number of turns for such reliability. Also given that parents differ in their communication style, which affects the amount of language used by a child, this could be a confounding variable if we were to use the videos as estimates of language ability. Secondary child outcomes are weak. They rely on parent reports and are not sensitive to advances, but rather child weaknesses. No educator ratings are planned. Why not use a functional measure, such as the Vineland. Alternatively, the investigators could code child language from the MRBC videos. Response: We are capturing changes in child language through our primary outcomes measures, a standardized composite language measure (the PLS- 5) and a functional measure (the FOCUS- 34). Changes in parent behaviour are captured through the MRBCS, - an observation schedule shown to capture key characteristics associated with language growth over time (Down et al., 2015; Levickis et al., 2014; Smith et al., 2019) . The secondary outcome measures are as the reviewer suggests parent proxy measures, however literature suggests that parental measures are considered reliable and with acceptable concurrent validity (Feldman et al., 2005). The CLASS secondary outcome measure is a reliable measure which will allow us to assess change in the quality of interactions between teachers and students in the classroom, this is an aspect of our logic model which we deem important to capture. The Vineland is a measure of overall cognition rather than one that focuses specifically on language. We have not included educator ratings of children, as the staff working with children are not always consistent and they are working with large groups of children, only some of which are included in the evaluation. We do not want them to focus their attention/prioritise those in the evaluation over and above those who are not. Consider dropping the health-related quality-of-life measure as it has no relation to the intervention. Response – We agree that the HRQL measures are not ideal and may not be sensitive to the changes that we expect as a result of our intervention, this was the case in our pilot trial. However, our pilot trial assessments took place over a short time period and it is not recommended to complete these measures over a period shorter than a year. Improvement in language outcomes are associated with overall well-being and these HRQL measures do ask about communication, which is at the core of our intervention. We do not have other measures at our disposal that can generate QALYs and are therefore suitable for a primary cost effectiveness analysis. Rethink the economic analyses based on QALYs and HRQOL. Response - We have given these measures considerable thought and in discussion with our health economist had decided to include them as they are not onerous to complete and there are currently no better alternatives. We have however also included the FOCUS – 34 as our functional measure and the PLS-5 scores will be used in our secondary cost effectiveness analysis. Our pilot trial included a value of information analysis, and indicated that there was value in collecting further information in a large scale trial. The randomization of sites scheme. The investigators have not discussed the implications if a site that participated in Round 1 of the intervention is randomized to be control in Round 2. Isn’t it likely that those trained educators will continue to use what they have learned in the next round? What about if classes contain siblings of previous participants? Response - Round 2 will involve the recruitment of 4 additional sites (in different areas) and will have no relationship with the sites recruited in round 1. Down, K., Levickis, P., Hudson, S., Nicholls, R. and Wake, M. (2015), Measuring maternal responsiveness. Child Care Health Dev, 41: 329-333. https://doi.org/10.1111/cch.12174 Feldman HM, Dale PS, Campbell TF, Colborn DK, Kurs-Lasky M, Rockette HE, Paradise JL. Concurrent and predictive validity of parent reports of child language at ages 2 and 3 years. Child Dev. 2005 Jul-Aug;76(4):856-68. doi: 10.1111/j.1467-8624.2005.00882.x. PMID: 16026501; PMCID: PMC1350485. Levickis, Penny PhD *,†,‡ ; Reilly, Sheena PhD *,‡ ; Girolametto, Luigi PhD § ; Ukoumunne, Obioha C. PhD ‖ ; Wake, Melissa MD *,†,‡ . Maternal Behaviors Promoting Language Acquisition in Slow-to-Talk Toddlers: Prospective Community-based Study. Journal of Developmental & Behavioral Pediatrics 35(4):p 274-281, May 2014. | DOI: 10.1097/DBP.0000000000000056 Smith, J., Levickis, P., Eadie, T., Bretherton, L., Conway, L., & Goldfeld, S. (2019). Associations between early maternal behaviours and child language at 36 months in a cohort experiencing adversity. International journal of language & communication disorders , 54 (1), 110–122. https://doi.org/10.1111/1460-6984.12435 View more View less Competing Interests None reply Respond Report a concern Feldman H. 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