Promoting Positive Adolescent Mental Health (PPAMH!) for School Climate: protocol for a feasibility randomised control trial in secondary schools

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This paper describes the protocol for a feasibility cluster randomized controlled trial of the Promoting Positive Adolescent Mental Health (PPAMH!) for School Climate intervention in six secondary schools in Bradford, with three schools receiving the multi-component whole-school program and three in usual care. The intervention is delivered by a “well-being mentor” working half the week and includes whole-school activities (e.g., assemblies), peer workshops, and one-to-one sessions, adapted from prior trials in India and Australia that targeted bullying, depression, and risk behaviours. Key outcomes are feasibility and implementation measures, including how many activities are run and the ability to access routine education and self-report mental health data, with staff and mentor interviews capturing barriers and changes to the intervention. The study explicitly does not examine intervention effects on school absences or other wellbeing outcomes, and is therefore limited to testing implementability rather than efficacy. This paper does not explicitly discuss endometriosis or adenomyosis; it was included in the corpus via a keyword match in the upstream search index.

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Abstract

Introduction: We describe a feasibility randomised controlled trial to determine if it is possible to implement a full cluster-randomised trial of a multi-component whole-school intervention aiming to improve the school climate. The Promoting Positive Adolescent Mental Health (PPAMH!) intervention will be adapted from an intervention previously trialled in India and Australia that reduced bullying, depression and risk behaviours among students. Methods We will randomise six secondary schools in Bradford in a feasibility trial. Three schools will receive the intervention and three will act as the ‘usual care’ control condition. We will collect quantitative and qualitative data on the implementation through activity logs and interviews with staff and well-being mentors. We will determine the feasibility of accessing and using routine education data and self-report mental health data as outcomes in the full trial. Results This study will provide information about the acceptability and feasibility of delivering and evaluating the school climate intervention in secondary schools. Conclusions This is the first study to deliver a promising whole school climate intervention in the UK. The results of this feasibility trial will inform the decision to embark on a full trial and further intervention adaptations as needed. Trial registration ISRCTN registry reference ISRCTN14856201
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Keywords School based interventions, School attendance, Mental health, Secondary schools ALL Metrics - Views Downloads How to cite this article Wadman R, Taylor O, Hudson K et al. Promoting Positive Adolescent Mental Health (PPAMH!) for School Climate: protocol for a feasibility randomised control trial in secondary schools [version 1; peer review: 2 approved with reservations]. NIHR Open Res 2024, 4:66 (https://doi.org/10.3310/nihropenres.13678.1) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente Select a format first ▬ ✚ Study Protocol [version 1; peer review: 2 approved with reservations] Ruth Wadman https://orcid.org/0000-0003-4205-0631 1, Olivia Taylor1, Kristian Hudson2, [...] Dan Lewer https://orcid.org/0000-0003-3698-7196 2, Catherine Hewitt https://orcid.org/0000-0002-0415-3536 1, John Pickavance https://orcid.org/0000-0002-5259-5291 2, Joseph Pryce3, John Wright2, Simon Gilbody1Ruth Wadman https://orcid.org/0000-0003-4205-0631 1, Olivia Taylor1, [...] Kristian Hudson2, Dan Lewer https://orcid.org/0000-0003-3698-7196 2, Catherine Hewitt https://orcid.org/0000-0002-0415-3536 1, John Pickavance https://orcid.org/0000-0002-5259-5291 2, Joseph Pryce3, John Wright2, Simon Gilbody1 PUBLISHED 24 Oct 2024 Author details Author details 1 Health Sciences, University of York, York, England, YO10 5DD, UK 2 Bradford Teaching Hospitals NHS Foundation Trust, Bradford Institute for Health Research, Bradford, England, BD9 6RJ, UK 3 London School of Hygiene & Tropical Medicine, London, England, WC1E 7HT, UK 2 Bradford Teaching Hospitals NHS Foundation Trust, Bradford Institute for Health Research, Bradford, England, BD9 6RJ, UK 3 London School of Hygiene & Tropical Medicine, London, England, WC1E 7HT, UK Ruth Wadman Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Resources, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Resources, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Olivia Taylor Roles: Conceptualization, Methodology, Project Administration, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Methodology, Project Administration, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Kristian Hudson Roles: Methodology, Project Administration, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Project Administration, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Dan Lewer Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Catherine Hewitt Roles: Methodology, Supervision, Writing – Review & Editing Roles: Methodology, Supervision, Writing – Review & Editing John Pickavance Roles: Methodology, Project Administration, Writing – Review & Editing Roles: Methodology, Project Administration, Writing – Review & Editing Joseph Pryce Roles: Conceptualization, Methodology, Writing – Review & Editing Roles: Conceptualization, Methodology, Writing – Review & Editing John Wright Roles: Conceptualization, Funding Acquisition, Resources, Supervision, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Resources, Supervision, Writing – Review & Editing Simon Gilbody Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing OPEN PEER REVIEW REVIEWER STATUS We describe a feasibility randomised controlled trial to determine if it is possible to implement a full cluster-randomised trial of a multi-component whole-school intervention aiming to improve the school climate. The Promoting Positive Adolescent Mental Health (PPAMH!) intervention will be adapted from an intervention previously trialled in India and Australia that reduced bullying, depression and risk behaviours among students. We will randomise six secondary schools in Bradford in a feasibility trial. Three schools will receive the intervention and three will act as the ‘usual care’ control condition. We will collect quantitative and qualitative data on the implementation through activity logs and interviews with staff and well-being mentors. We will determine the feasibility of accessing and using routine education data and self-report mental health data as outcomes in the full trial. This study will provide information about the acceptability and feasibility of delivering and evaluating the school climate intervention in secondary schools. This is the first study to deliver a promising whole school climate intervention in the UK. The results of this feasibility trial will inform the decision to embark on a full trial and further intervention adaptations as needed. ISRCTN registry reference ISRCTN14856201 PPAMH! (‘Promoting Positive Adolescent Mental Health) for School Climate encourages a positive environment to support student wellbeing. A ‘well-being mentor’ will work in each school for half of the week. They will do whole-school activities such as assemblies, peer group activities such as workshops, and one-to-one activities with pupils. The intervention focuses on aiding pupils to have their say on school policies and curriculum by creating a participative school environment. Interventions using a similar approach have been done in India and Australia. We think that PPAMH! could improve student attendance. The research trial in India found that it reduced bullying and feelings of depression. We will adapt the trial to be suitable for schools in Bradford through workshops with students and staff. This initial trial will involve six secondary schools in Bradford. Schools will be randomly chosen to either being a control school or to receive the intervention. The main outcome is the successful running of the intervention in the schools, for example looking at how many activities were completed and by how many students. We will not study the effect of the intervention on school absences or other aspects of wellbeing. We will interview school staff members who are involved in providing the intervention in the schools and the well-being mentors. This will tell us about barriers to the intervention, how these could be overcome and changes that schools make to the intervention. We will also see how well we are able to access the data we plan to use in the full trial, which is school absences (from routine educational data) and mental health data such as depression and anxiety symptoms (via student surveys). We will plan to do a full trial if the feasibility trial shows the PPAMH! intervention can be successfully set up in schools. School based interventions, School attendance, Mental health, Secondary schools Corresponding Author(s) Ruth Wadman ([email protected]) Grant information: This project is funded by the National Institute for Health Research (NIHR) under its [‘Research for Patient Benefit (RfPB) Programme’ (Grant Reference Number PB-PG- NIHR205448)]. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright: © 2024 Wadman R 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: Wadman R, Taylor O, Hudson K et al. Promoting Positive Adolescent Mental Health (PPAMH!) for School Climate: protocol for a feasibility randomised control trial in secondary schools [version 1; peer review: 2 approved with reservations]. NIHR Open Res 2024, 4:66 (https://doi.org/10.3310/nihropenres.13678.1) First published: 24 Oct 2024, 4:66 (https://doi.org/10.3310/nihropenres.13678.1) Latest published: 24 Oct 2024, 4:66 (https://doi.org/10.3310/nihropenres.13678.1) The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The prevalence of mental health problems is increasing in young people. In the UK, rates of diagnosis for anxiety, depression, attention disorders, and eating disorders doubled between 2003 and 20181, while the COVID-19 pandemic and associated restrictions likely had an additional impact2. The Mental Health of Children and Young People in England 2022 report found that 18% of 7- to 16-year-olds and 22% of 17- to 24-year-olds had a probable mental health disorder3. In addition to the impact of mental health problems on young people and their families, young people’s mental health difficulties are associated with large economic costs and impacts on public services including the NHS4. Increasing demand for, and pressures on, specialist services such as Child and Adolescent Mental Health Services (CAMHS)5, has led to young people facing longer waiting times or having no contact with support services. Most mental health problems start by adolescence, with half established by age 146–7. Elevated mental health symptoms and diagnoses among adolescents are predictive of later mental health problems and are associated with worse outcomes in multiple areas of daily life in adulthood, including educational achievements and employment patterns8–11. Children and young people with mental health problems are at risk of higher school absence rates. In England in 2021, 13% of children with a probable mental disorder missed more than 15 days of school in one year, compared with 4% of those without a mental health disorder12. Schools play a crucial role in supporting wellbeing and mental health, with children spending more time in school than any other formal institution. School-based preventative interventions for mental health include universal approaches (for all students), selective interventions targeted at at-risk groups, and indicative (early) interventions for individuals with mental health symptoms. Universal social and emotional learning (SEL) interventions, that aim to improve social and emotional knowledge and skills, have been found to reduce symptoms of depression and anxiety at least in the short-term but there is limited evidence of the longer-term effect of SEL13. Evidence also indicates that targeted depression- and anxiety-focused school-based interventions, such as targeted cognitive behavioural therapy (CBT) delivered by external experts, can reduce symptoms in the short- and medium-term14,15. However, the effectiveness of universal school-based CBT preventative interventions is less apparent, with two trials reporting no improvements in mental health symptoms16,17. These large-scale evaluations present a mixed picture for the effectiveness of universal school-based interventions. A UK trial of classroom-based mindfulness (MYRIAD trial) found no evidence of benefit in terms of reducing risk of depression or improving socioemotional-behavioural functioning18 and additional analyses suggested the intervention may harm students at risk of mental health problems19. Findings like these have led to calls for researchers to recognise that universal school-based interventions can lead to negative outcomes in children and young people and to look for different intervention models20. There are some multicomponent whole-school preventative mental health interventions based on the World Health Organisation ‘Health Promoting Schools’ framework. A recent cluster-RCT evaluated a multicomponent whole-school health promotion intervention delivered in secondary schools by lay counsellors in Bihar, India (SEHER trial). They reported significant improvements in comparison to a control group in measures of school climate, depression, attitudes towards gender equity, bullying and victimisation21,22. Significant effects on these outcomes were observed at the end of year 1, with further improvements observed after two years. The study further reported that students in intervention schools enjoyed the activities and found them interesting and informative. Previously, an RCT of a similar intervention in Australia (the Gatehouse project) observed a significant reduction in adolescent risk behaviours such as drinking and regular smoking23,24. We aim to explore the applicability of this ‘Health Promoting Schools’ framework in the UK. We will work with schools and young people to adapt the SEHER intervention and intervention resources to be appropriate and acceptable to secondary schools in a city in the UK. We will test the adapted intervention and its implementation in a feasibility trial before doing a full trial (aiming to include all secondary schools). A key factor is whether a full trial can be done using mental health data collected as part of the Born in Bradford cohort study (further details to follow). The study aim is to carry out a feasibility trial to determine if it is possible to implement a cluster-randomised trial of a multi-component whole-school intervention aiming to improve the school climate (PPAMH!). The feasibility trial will not aim to estimate the effect of the intervention, but to learn whether the intervention and research are feasible. A full trial is planned if the intervention is feasible, and the resources are identified. The specific objectives are to: 1. Establish whether secondary schools can be recruited to take part in the trial. 2. Pilot the randomisation process, including accessing the school-level data for the factors used in randomisation. 3. Assess the acceptability of the PPAMH! intervention to school staff and the well-being mentors involved in implementation using qualitative research methods, including barriers faced and possible solutions. 4. Assess adherence to the PPAMH! intervention by collecting data on the activities undertaken in school (e.g. number of sessions and number attending). 5. Establish whether school absence data and mental health data can be accessed via the education record and the Born in Bradford cohort study respectively. The design is a feasibility cluster-randomised trial of an intervention that aims to create a more positive school environment. The feasibility trial will involve randomisation of six schools with a primary outcome of the successful delivery of the intervention in schools determined by 1) qualitative interview data from staff involved in implementing the intervention and 2) quantitative data on intervention delivery via an activity log including number of sessions and attendees. The quantitative outcome data we will access in this study is either routine data from the education record or is data that is already being collected as part of the Born in Bradford cohort study. The cohort study has HRA ethical approval (IRAS number 295413; REC reference number 21/YH/0261) and this approval includes plans for supporting interventions that will use Born in Bradford outcome data. The Born in Bradford study information and informed consent process included information about the use of participant data to evaluate interventions, to ensure that cohort participants are fully informed. The study has been reviewed by the Health Sciences’ Research Governance Committee (University of York) and received approval on 15th March 2024 (Ref: HSRGC/2024/616/F). Informed written consent from participating school leaders, school staff and wellbeing mentors will be obtained by the research team. Primary outcome Successful delivery of the intervention in schools determined by descriptive quantitative data on intervention delivery via an activity log of number of sessions, frequency of sessions, number of attendees and evidence of training to support delivery. Assessment of qualitative data about implementation via interviews with relevant school staff (and the wellbeing mentors) involved in implementing the intervention. Secondary outcomes Successful collection of school absences data, as a proxy measure of the school environment. This was selected as the planned primary outcome for the full trial by young people and stakeholders. It will be available for all pupils via the educational record (routine data). Access to mental health and wellbeing data of year 9 students, collected in the Born in Bradford cohort study, including mental health problems such as depression and anxiety (measured by RCADS-25), mental wellbeing (measured by SWEMWBS) and bullying. The study is located in Bradford, an urban, multicultural city in the North of England, UK. Bradford is one of the largest local authorities in England with a population of 547,000, and has one of the youngest and most diverse populations in the UK25. Within Bradford there are 59 secondary schools, including 7 maintained schools, 31 academies, 11 independent schools, 9 special schools and 1 independent sixth form college. This study will make use of survey mental health data being collected in Bradford secondary schools as part of the Born in Bradford cohort study26. Born in Bradford’s ‘Age of Wonder’ study is a continuation and expansion of the Born in Bradford longitudinal birth cohort study that began in 2007. Between 2007 and 2011, 12,453 women were recruited who delivered 13,786 live infants27. Half of the Born in Bradford participants live within the fifth most deprived wards for England and Wales, and 45% are of Pakistani origin28. From 2021, Born in Bradford have expanded the cohort to include up to 30,000 young people, with the aim of following these young people through adolescence and into adulthood. Preliminary results from the Born in Bradford survey of young people in 2022–23 (N ~ 5,000) suggest the prevalence of depression and anxiety in young people is similar to other parts of England, and rates of self-harm and probable eating disorders elevated29. Additionally, school absences and persistent absences (defined as missing 10% or more of school) are higher than regional and national averages, with absence rates continuing to rise despite improvements being seen in other parts of Yorkshire and England30. A group of young people (aged 16 to 24), The Bradford Healthy Minds Apprentices were consulted at the design phase of the study in a workshop held in September 2022. This group met again in February 2023 to decide upon the name of the intervention and to design the study logo. In May 2023, the group met to review the implementation details for the intervention including who should deliver the intervention in schools. There will be additional input from young people and school staff to adapt the intervention (details below). Inclusion criteria Secondary school in Bradford. Actively participating in the Born in Bradford cohort study. Exclusion criteria School is outside of Bradford. School is not part of the Born in Bradford cohort study. Schools will be recruited via existing research links with secondaries in Bradford through the Born in Bradford cohort study26. School staff participants will be recruited once the intervention is underway and the staff relevant to the intervention implementation are identified. Intervention delivery will take place in the schools and will be led by ‘wellbeing mentors’: non-clinical community workers. A school climate intervention was identified as a priority by young people and stakeholders in Bradford. The intervention will be adapted for each school through research involvement activities and workshops with young people and key stakeholders such as school staff. For example, students will be asked to choose the topics of focus in the intervention for each half-term (i.e. six weeks). The PPAMH! intervention is a multi-level whole school intervention. The intervention’s conceptual framework emphasises the importance of a positive school climate. The name of this adapted intervention ‘Promoting Positive Adolescent Mental Health (PPAMH!) for School Climate’ was chosen by our young person’s advisory group. A positive school climate can be described as one that features a sense of belonging to the school, a participative school environment, student commitment to academic values, and supportive relationships among school students, teachers, parents, and leadership. Improvements to the school climate are targeted using a multi-level school-based intervention, organised at the whole-school, peer group and individual levels. PPAMH! includes four priority areas: promoting social skills; engaging the school community (i.e., pupils, teachers, and parents) in school decision-making processes; improving understanding of health and risk behaviours; and enhancing problem-solving skills. By promoting a positive school climate, supportive relationships and enhancing emotional and mental health knowledge, the intervention aims to improve student mental health and wellbeing (i.e. reduced feelings of depression and less bullying)21. The PPAMH! intervention itself will be delivered by two voluntary sector non-clinical community workers (‘well-being mentors’), employed by a local mental health charity and supported by the local NHS Trust. In addition to oversight from the charity, the research team will provide training and regular meetings and site visits for the wellbeing mentors. A well-being mentor will be in intervention schools 50% of the school week to facilitate whole school activities. They will also run peer group sessions and 1-1 activities with year 9 pupils. Example activities are awareness generation, policy review, workshops and skills training (see Table 1). Each half-term (six weeks) will have a different topic of focus, which will have been selected by the students and school staff. Example topics may include mental health and wellbeing, study skills, and rights and responsibilities. The intervention needs to be adapted for Bradford, including the intervention components (examples are given in Table 1) and the support that will be provided to schools. We will work with young people and schools to develop an intervention handbook and training package. For every intervention school, we aim to hold three one-hour workshops with secondary school students (10–15 participants per workshop) and three one-hour workshops with relevant school staff (6–8 participants per workshop). These will be in-person at school or online, depending on the preferences of the attendees. Workshop 1 will prioritize the topics to be covered as part of the intervention, such as mental health, relationships and rights and responsibilities. Workshop 2 will seek feedback on the proposed activities that form the intervention. Workshop 3 will discuss the delivery of the intervention and how to engage students, such as assemblies, topic boards and workshops. This information will be used to adapt the intervention handbook and resources. The number of workshops held will depend on the timing of recruitment and randomisation of schools. A pragmatic approach will be taken and fewer workshops may be necessary to fit with the school timetable. Schools will be randomised to either being a control school (three schools) or receiving the intervention (three schools). Schools randomised to the control arm of the pilot trial will not be required to do anything additional. The control condition is ‘usual care’. Schools will be randomised using minimisation. Minimisation will be undertaken in minimPy (or equivalent package in R) using naïve minimisation. Minimisation factors will include 1) baseline absence rate, 2) number of pupils from non-White ethnic groups and 3) number of female pupils. The proposed timeline for the study is given in Figure 1. Staff and student workshops with the three intervention schools, where we will adapt the intervention, will take place in the Autumn term 2024 (September through to December). Should a full trial take place, we will describe characteristics and baseline outcome measures for schools and pupils using routinely collected data (which is generally publicly available via systems such as Get Information about Schools - GOV.UK get-information-schools.service.gov.uk). The primary outcome for the full trial will be school absences taken from the education record (routine data). This will be provided at term and pupil level by participating schools, with minimal additional pupil level variables. We will also collect data on age, year group, sex, ethnicity and eligibility for free school meals. Secondary outcomes include depression and anxiety measured using the Revised Child Anxiety and Depression Scale (RCADS-25)31, wellbeing measured using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWEBS)32 and bullying (bespoke questions). These data are being collected in Bradford schools as part of the Born in Bradford cohort study. For the feasibility trial, we will just determine how feasible it is to access and use this data (i.e. we will not make any comparison in outcomes between intervention and control schools). Relevant members of school staff who are involved in the intervention implementation will be invited to take part in interviews: one initial long form interview and a series of rapid 15-minute interviews (repeated approximately every six weeks). We would ideally include all staff members involved in implementing the intervention, but at a minimum we would recruit three members of school staff in each school. The ‘wellbeing mentors’ will also be interviewed and in addition will be asked to keep a log of PPAMH! activities undertaken in the school as part of the implementation evaluation. This will include data on the number of sessions, frequency of sessions, number of attendees, evidence of training to support delivery, any adaptations made by the school to the intervention or its delivery, any implementation strategies they have used, and any other relevant information identified by our implementation specialist. The feasibility trial will not include formal statistical analysis. We will describe characteristics of participating schools and the proportion of missing data for the outcomes. We will summarise the quantitative implementation data descriptively. If the results of the feasibility trial show that no major changes are required to the intervention, a full trial is planned. We will publish a protocol for the full trial with detailed analysis plans. The initial long-form interview will be transcribed. The rapid response interviews will be audio recorded, listened to, and then summarised into lightning reports. The lightning reports will summarise what is going well, what is not going so well, and any key insights participants have in regard to PPAMH! and its implementation. Lightning reports and long-form interview data will then be coded using the Consolidated Framework for Implementation Research (CFIR) 2.0 and The Expert Recommendations for Implementing Change (ERIC) list. The CFIR analysis will result in a list of barriers and facilitators to implementation. The ERIC will highlight which implementation strategies sites have used to implement PPAMH! and overcome contextual barriers. Adoption and acceptability will also be captured the interview data by asking participants about these directly. Sustainability will be measured in the final rapid interview using the Program Sustainability Assessment Tool, a 15 minute sustainability questionnaire. Determinants within the CFIR, the implementation strategies listed in ERIC and adoption, and acceptability will be used as codes in NVivo to produce a framework matrix that summarises the information housed under each code at each site. CFIR valence and strength coding will allow us to prioritise barriers and facilitators. We will identify the implementation strategies used to address these. We will then aim to provide a rationale (causal mechanism) for how these strategies worked to address barriers and contribute to our collected implementation outcomes and present this data within implementation research logic models (IRLMs) for each site. Data collected on the activities undertaken in schools as part of the intervention, along with the qualitative implementation data, will be used to determine whether a full trial will take place. Each school will have a target for the number of intervention activities completed each half-term/year adapted from the original SEHER trial, for example four awareness-generating assembles per month and two health promotion committee meetings per year21. The intervention activity logs will be compared against these targets. The decision to progress to a full trial will be based on whether these targets have largely been met and if the qualitative analysis of implementation data strongly suggests that school staff and well-being mentors thought the intervention is acceptable and can be implemented in school. If the quantitative outcome data can be effectively accessed as part of the feasibility trial, then this outcome data will be included in the full trial (i.e. as an internal pilot). If the data access is not feasible or limited due to missing data, then the schools included in the feasibility trial will not be included in the full trial (i.e. an external pilot)33. This will also be the case if the implementation analysis suggests that a substantial amount of modification to the PPAMH! intervention is required for it to be successfully implemented in schools. Possible harm as a result of the study will be monitored (e.g. mental distress including self-harm/suicidal behaviour). Standard operating procedures for reporting adverse events will be adapted by the study team. The wellbeing mentors will be prompted to record any adverse events related to the intervention as part of their intervention activity log. The schools’ existing safe-guarding policies will be adhered to. The Trial Steering Committee will review adverse events throughout the trial for safety. If there is evidence of harm due to the intervention or measures used, this may result in a possible recommendation to stop the trial. Due to the nature of the intervention it is not possible for schools to be blinded to study allocation. If a full trial is established, the analyst/statistician will be blinded to the intervention status of each school. Secondary outcomes from the Born in Bradford cohort study are likely to have missing data, principally because of organisational issues in the participating schools on the days of data collection and also due to some pupils being absent on the day of the survey. This study aims to examine the feasibility of implementing a multi-component whole school intervention for improving the school climate in Bradford secondary schools. The proposed outcome measures of school absence and mental health will be taken from routine data and the Born in Bradford cohort study. This study will explore the feasibility of implementing the intervention and accessing the required data for a full trial. The PPAMH! intervention will be adapted from the SEHER programme trialled in Bihar, India. SEHER has shown promising results in improving the school climate and reducing symptoms of depression21–22. This is the first time this intervention has been implemented in the UK. The results will inform the decision to move to a full trial and will add to the body of literature evaluating school-based mental health interventions. The study has been reviewed by the Health Sciences’ Research Governance Committee (University of York) and received approval on 15th March 2024 (Ref: HSRGC/2024/616/F). Informed written consent from participating school leaders, school staff and wellbeing mentors will be obtained by the research team. Figshare: Repository: PPAMH! for School Climate feasibility trial measures, "https://doi.org/10.6084/m9.figshare.27233055 The project contains the following files: Figshare: Study materials PPAMH! for school climate feasibility protocol, https://figshare.com/articles/online_resource/Study_materials_PPAMH_for_school_climate_feasibility_protocol/27188265?file=49670706 The project contains the following files: Figshare: SPIRIT Checklist for PPAMH! for School Climate feasibility protocol, https://doi.org/10.6084/m9.figshare.26325616 The project contains the following files: Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0)(https://creativecommons.org/licenses/by/4.0/). The Program Sustainability Assessment Tool is available online: https://www.sustaintool.org/psat/assess/ This report is independent research funded by the National Institute for Health and Care Research Yorkshire and Humber Applied Research Collaboration. The views expressed in this publication are those of the author(s) and not necessarily those of the National Institute for Health and Care Research or the Department of Health and Social Care. We are very grateful to the Bradford Healthy Minds Apprentices who were involved in the Patient and Public Involvement activities for this study. Faculty Opinions recommendedReferences - 1. Cybulski L, Ashcroft DM, Carr MJ, et al.: Temporal trends in annual incidence rates for psychiatric disorders and self-harm among children and adolescents in the uk, 2003–2018. BMC Psychiatry. 2021; 21(1): 229. PubMed Abstract | Publisher Full Text | Free Full Text - 2. Hafstad GS, Augusti EM: A lost generation? COVID-19 and adolescent mental health. Lancet Psychiatry. 2021; 8(8): 640–1. PubMed Abstract | Publisher Full Text | Free Full Text - 3. Newlove-Delgado T, Marcheselli F, Williams T, et al.: Mental health of children and young people in England. NHS Digital, Leeds. 2022. Reference Source - 4. 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PubMed Abstract | Publisher Full Text | Free Full Text Author details Author details 1 Health Sciences, University of York, York, England, YO10 5DD, UK 2 Bradford Teaching Hospitals NHS Foundation Trust, Bradford Institute for Health Research, Bradford, England, BD9 6RJ, UK 3 London School of Hygiene & Tropical Medicine, London, England, WC1E 7HT, UK 2 Bradford Teaching Hospitals NHS Foundation Trust, Bradford Institute for Health Research, Bradford, England, BD9 6RJ, UK 3 London School of Hygiene & Tropical Medicine, London, England, WC1E 7HT, UK Ruth Wadman Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Resources, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Project Administration, Resources, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Olivia Taylor Roles: Conceptualization, Methodology, Project Administration, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Methodology, Project Administration, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Kristian Hudson Roles: Methodology, Project Administration, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Methodology, Project Administration, Resources, Writing – Original Draft Preparation, Writing – Review & Editing Dan Lewer Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Catherine Hewitt Roles: Methodology, Supervision, Writing – Review & Editing Roles: Methodology, Supervision, Writing – Review & Editing John Pickavance Roles: Methodology, Project Administration, Writing – Review & Editing Roles: Methodology, Project Administration, Writing – Review & Editing Joseph Pryce Roles: Conceptualization, Methodology, Writing – Review & Editing Roles: Conceptualization, Methodology, Writing – Review & Editing John Wright Roles: Conceptualization, Funding Acquisition, Resources, Supervision, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Resources, Supervision, Writing – Review & Editing Simon Gilbody Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information This project is funded by the National Institute for Health Research (NIHR) under its [‘Research for Patient Benefit (RfPB) Programme’ (Grant Reference Number PB-PG- NIHR205448)]. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Copyright © 2024 Wadman R 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. metrics VIEWS $counts.viewCount downloads Citations CITE how to cite this article Wadman R, Taylor O, Hudson K et al. Promoting Positive Adolescent Mental Health (PPAMH!) for School Climate: protocol for a feasibility randomised control trial in secondary schools [version 1; peer review: 2 approved with reservations]. NIHR Open Res 2024, 4:66 (https://doi.org/10.3310/nihropenres.13678.1) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. track receive updates on this article Track an article to receive email alerts on any updates to this article. Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE ApprovedThe 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 approvedFundamental flaws in the paper seriously undermine the findings and conclusions Version 1 VERSION 1 PUBLISHED 24 Oct 2024 Views 0 How to cite this report: Reynolds K. Reviewer Report For: Promoting Positive Adolescent Mental Health (PPAMH!) for School Climate: protocol for a feasibility randomised control trial in secondary schools [version 1; peer review: 2 approved with reservations]. NIHR Open Res 2024, 4:66 (https://doi.org/10.3310/nihropenres.14852.r33625) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/4-66/v1#referee-response-33625 https://openresearch.nihr.ac.uk/articles/4-66/v1#referee-response-33625 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 17 Dec 2024 Katherine Reynolds, The University of Melbourne, Melbourne, Victoria, Australia Approved with Reservations VIEWS 0 The manuscript outlines a feasibility trial for a school-wide intervention to improve student mental health and attendance outcomes. School climate is a central concept but is defined in ways that are not directly aligned to the academic work in this ... Continue reading 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 The manuscript outlines a feasibility trial for a school-wide intervention to improve student mental health and attendance outcomes. School climate is a central concept but is defined in ways that are not directly aligned to the academic work in this area. For example the definition includes belonging and participation as well as the more typical aspects of academic values and relations; “A positive school climate can be described as one that features a sense of belonging to the school, a participative school environment, student commitment to academic values, and supportive relationships among school students, teachers, parents, and leadership” (p. 6). The outcome variables of interest for the project as a whole are The intervention involves school specific activities and initiatives that relate to four areas It will involve at least three workshops for student and staff groups ( 6 in total) and other activities co-ordinated by a staff member 0.5FTE whose role is to facilitate whole school activities. Many aspects of the feasibility study are clear and well developed. An aspect that remains less clear is how to assess “school climate” itself in the full trial. The focus is on individual-level student outcomes that are not specific to learning or school belonging or related to the aims of enhancing problem solving and social skills for example. It seems in the full trial additional measures will need to be incorporated to fully investigate the intervention. Also the intervention and activities not being oriented to the school-group -level (e.g., who we are as a group, what do we do here, what do we value) is a missed opportunity. The outcome variables of interest for the project as a whole are - School absences data - Born in Bradford cohort study mental health depression and anxiety, mental wellbeing and bullying. The intervention involves school specific activities and initiatives that relate to four areas - promoting social skills; - engaging the school community (i.e., pupils, teachers, and parents) in school decision-making processes; - improving understanding of health and risk behaviours; and - enhancing problem-solving skills. It will involve at least three workshops for student and staff groups ( 6 in total) and other activities co-ordinated by a staff member 0.5FTE whose role is to facilitate whole school activities. Many aspects of the feasibility study are clear and well developed. An aspect that remains less clear is how to assess “school climate” itself in the full trial. The focus is on individual-level student outcomes that are not specific to learning or school belonging or related to the aims of enhancing problem solving and social skills for example. It seems in the full trial additional measures will need to be incorporated to fully investigate the intervention. Also the intervention and activities not being oriented to the school-group -level (e.g., who we are as a group, what do we do here, what do we value) is a missed opportunity. - 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? Partly Competing Interests: No competing interests were disclosed. Reviewer Expertise: educational psychology, children and youth well-being and mental health. CITE HOW TO CITE THIS REPORT Reynolds K. Reviewer Report For: Promoting Positive Adolescent Mental Health (PPAMH!) for School Climate: protocol for a feasibility randomised control trial in secondary schools [version 1; peer review: 2 approved with reservations]. NIHR Open Res 2024, 4:66 (https://doi.org/10.3310/nihropenres.14852.r33625) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/4-66/v1#referee-response-33625 https://openresearch.nihr.ac.uk/articles/4-66/v1#referee-response-33625 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. Views 0 How to cite this report: Kristjánsson Á. Reviewer Report For: Promoting Positive Adolescent Mental Health (PPAMH!) for School Climate: protocol for a feasibility randomised control trial in secondary schools [version 1; peer review: 2 approved with reservations]. NIHR Open Res 2024, 4:66 (https://doi.org/10.3310/nihropenres.14852.r33276) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/4-66/v1#referee-response-33276 https://openresearch.nihr.ac.uk/articles/4-66/v1#referee-response-33276 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Reviewer Report 25 Nov 2024 Álfgeir Kristjánsson, Department of Social and Behavioral Sciences, School of Public Health, West Virginia University, Morgantown, West Virginia, USA Approved with Reservations VIEWS 0 Thank you for the opportunity to review this manuscript. The manuscript describes the feasibility in implementing a pilot study as a preparation for a larger trail. School climate is an important concept that has been shown to relate to ... Continue reading 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 The manuscript describes the feasibility in implementing a pilot study as a preparation for a larger trail. School climate is an important concept that has been shown to relate to ... Continue reading Thank you for the opportunity to review this manuscript. The manuscript describes the feasibility in implementing a pilot study as a preparation for a larger trail. School climate is an important concept that has been shown to relate to mental and health and well being among youth in schools. Although the study report is largely clear and well written, I have a few comments related to levels of impact and analyses that I found challenging. Major comments - Unclear levels of causality and inference. Apparently the objective of the study is to improve School climate. School Climate is a mezzo level concept and thus requires mezzo level implementation and testing. Its effects are generated from social contextual functions at the school level and should impact whole schools and students. But the measurement of impact and inference in the proposed randomized study are solely based on individual level observations. School level impact appears absent for the study does not include any higher level measurement points and analyses. At a minimum, how school climate is observed solely via individual level observations needs solidified. - Challenging argument re individual vs. whole school levels. School Climate appears described with a selection of individual level objectives, such as reducing individual level feelings of depression and bullying delivered via "well-being mentors". How a series of short-term individual level interventions will lead to improved "school climate" at the school level is not clear. The manuscript describes the feasibility in implementing a pilot study as a preparation for a larger trail. School climate is an important concept that has been shown to relate to mental and health and well being among youth in schools. Although the study report is largely clear and well written, I have a few comments related to levels of impact and analyses that I found challenging. Major comments - Unclear levels of causality and inference. Apparently the objective of the study is to improve School climate. School Climate is a mezzo level concept and thus requires mezzo level implementation and testing. Its effects are generated from social contextual functions at the school level and should impact whole schools and students. But the measurement of impact and inference in the proposed randomized study are solely based on individual level observations. School level impact appears absent for the study does not include any higher level measurement points and analyses. At a minimum, how school climate is observed solely via individual level observations needs solidified. - Challenging argument re individual vs. whole school levels. School Climate appears described with a selection of individual level objectives, such as reducing individual level feelings of depression and bullying delivered via "well-being mentors". How a series of short-term individual level interventions will lead to improved "school climate" at the school level is not clear. - 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? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: Adolescent health promotion, community-based substance use prevention, school health. CITE HOW TO CITE THIS REPORT Kristjánsson Á. Reviewer Report For: Promoting Positive Adolescent Mental Health (PPAMH!) for School Climate: protocol for a feasibility randomised control trial in secondary schools [version 1; peer review: 2 approved with reservations]. NIHR Open Res 2024, 4:66 (https://doi.org/10.3310/nihropenres.14852.r33276) The direct URL for this report is: https://openresearch.nihr.ac.uk/articles/4-66/v1#referee-response-33276 https://openresearch.nihr.ac.uk/articles/4-66/v1#referee-response-33276 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. Alongside their report, reviewers assign a status to the article: - Approved - Approved with reservations - Not approved | Invited Reviewers | || |---|---|---| | 1 | 2 | | | Version 1 24 Oct 24 | read | read | - Álfgeir Kristjánsson, West Virginia University, Morgantown, USA - Katherine Reynolds, The University of Melbourne, Melbourne, Australia Sign up for content alerts You are now signed up to receive this alert 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 Provide sufficient details of any financial or non-financial competing interests to enable users to assess whether your comments might lead a reasonable person to question your impartiality. Consider the following examples, but note that this is not an exhaustive list: Examples of 'Non-Financial Competing Interests' - Within the past 4 years, you have held joint grants, published or collaborated with any of the authors of the selected paper. - You have a close personal relationship (e.g. parent, spouse, sibling, or domestic partner) with any of the authors. - You are a close professional associate of any of the authors (e.g. scientific mentor, recent student). - You work at the same institute as any of the authors. - You hope/expect to benefit (e.g. favour or employment) as a result of your submission. - You are an Editor for the journal in which the article is published. 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