Study Protocol for Assessing the Effectiveness, Implementation Fidelity and Uptake of Attachment & Child Health (ATTACHTM) Online: Helping Children Vulnerable to Early Adversity

Study Protocol for Assessing the Effectiveness, Implementation Fidelity and Uptake of Attachment & Child Health (ATTACHTM) Online: Helping Children Vulnerable to Early Adversity | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Study Protocol for Assessing the Effectiveness, Implementation Fidelity and Uptake of Attachment & Child Health (ATTACHTM) Online: Helping Children Vulnerable to Early Adversity Nicole Letourneau, Lubna Anis, Cui Cui, Ian Graham, Kharah Ross, and 13 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4487245/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 09 Apr, 2025 Read the published version in BMC Pediatrics → Version 1 posted 7 You are reading this latest preprint version Abstract Background Exposure to early childhood adversities, such as family violence, parental depression, or low-income, undermine parent-child relationship quality and attachment leading to developmental and mental health problems in children. Addressing impacts of early childhood adversity can promote children’s development, giving them the best start in life. Parental reflective function (RF), or parents' ability to understand their own and children's mental states, can strengthen parent-child relationships and attachment and buffer the negative effects of early adversity. We developed and tested ATTACH™ (Attachment and Child Health), an effective RF intervention program for parents and their preschool-aged children at-risk from early adversity. Pilot studies revealed significantly positive impacts of ATTACH™ from in-person ( n = 90 dyads) and online ( n = 10 dyads) implementation. The two objectives of this study are to evaluate: (1) effectiveness, and (2) implementation fidelity and uptake of ATTACH™ Online in community agencies serving at-risk families in Alberta, Canada. Our primary hypothesis is ATTACH™ Online improves children’s development. Secondary hypotheses examine whether ATTACH™ Online improves children’s mental health, parent-child relationships, and parental RF. Methods We will conduct an effectiveness-implementation hybrid (EIH) type 2 study. Effectiveness will be examined with a quasi-experimental design while implementation will be examined via descriptive quantitative and qualitative methods informed by Normalization Process Theory (NPT). Effectiveness outcomes examine children’s development and mental health, parent-child relationships, and RF, measured before, after, and 3 months post-intervention. Implementation outcomes include fidelity and uptake of ATTACH™ Online, assessed via tailored tools and qualitative interviews using NPT, with parents, health care professionals, and administrators from agencies. Power analysis revealed recruitment of 100 families with newborn to 36-month-old children are sufficient to test the primary hypothesis on 80 complete data sets. Data saturation will be employed to determine final sample size for the qualitative component, with an anticipated maximum of 20 interviews per group (parents, heath care professionals, administrators). Discussion This study will: (1) determine effectiveness of ATTACH™ Online and 2) understand mechanisms that promote implementation fidelity and uptake of ATTACH™ Online. Findings will be useful for planning spread and scale of an effective program poised to reduce health and social inequities affecting vulnerable families. Trial registration Name of registry: https://clinicaltrials.gov/. Registration number: NCT05994027 Study protocol ATTACH™ Online program Effectiveness-implementation hybrid (EIH) Type II study Quasi-experimental design Parenting program Reflective function Parent-child interaction Child development Normalization process theory Introduction Background and Rationale {6a and 6b} Impact of Early Adversities on Parent-Child Relationships and Children’s Development and Mental Health Exposure to early adversities such as family violence, parental depression, and low income, undermine children’s development and mental health (Bucci et al., 2016; Center on the Developing Child at Harvard University, 2010; Frameworks Institute, 2005; Shonkoff et al., 2012), with costs to society from lower school achievement, under-employment, and higher rates of chronic disease and mental health problems, over the lifespan (Bethell et al., 2014). Alarmingly, 50-70% of adult mental health problems stem from exposure to these early adversities (Jones, 2013; Kim-Cohen et al., 2003; Merikangas et al., 2009; Van Os et al., 1997). Impacts are observed in early childhood in the form of compromised cognitive development (e.g., communication, and personal-social, and problem-solving skills) and physical health (e.g., motor skills) (Kuehn, 2014; Shonkoff et al., 2012). Drawing from large population surveys in Alberta (n~5000), more than 25% of preschool-aged children are raised in families with at least one early adversity (Alberta Education, 2014; Metcalf A et al., 2011; Province of Alberta, 2011).Family violence occurs in 4% of childbearing families in Canada, a statistic believed to be low due to underreporting (Burczycka & Conroy, 2018). Negative impacts of exposure to family violence on children’s development and mental health are well established (Graham-Bermann et al., 2009; Jenney & Alaggia, 2018; Piotrowski & Letourneau, 2020; Vameghi et al., 2016).For example, 1- to 3-year-olds exposed to family violence experienced significant cognitive (i.e., problem-solving) and fine motor skill delays, assessed via the Ages and Stages Questionnaire (ASQ) – second edition (ASQ-2; n=51) (Letourneau et al., 2013).Similarly, 6- to 18-month-old children exposed to family violence experienced cognitive delays (i.e., communication, personal-social, and problem-solving skills) and gross and fine motor delays assessed via the ASQ-2 (n=750). Parental depression is also well-known to negatively impact children’s development and mental health (Abdollahi et al., 2017; Letourneau, Dennis, et al., 2012; Letourneau et al., 2017).For example, exposed 12- and 24-month-olds (n=1555) had significantly reduced cognitive development characterized by lower ASQ-2 communication scores (Valla et al., 2016),and exposed 2- to 6-year-olds (n=2231) had reduced ASQ-2 cognitive and gross motor developmental scores (Tuovinen et al., 2018). Depression affects 7-19% of mothers (Gavin et al., 2005; Howard et al., 2014) and 10% of fathers (Paulson & Bazemore, 2010)caring for children under three years of age. Nine percent of Canadian children live below the poverty line (Statistics Canada, 2019).Similar impacts of low-income on children’s ASQ development scores have also been observed (Potijk et al., 2013; Wei et al., 2015). Early adversities compromise parent-child relationships, characterized by reduced parental sensitivity/responsiveness, and insecure parent-child attachment (De Falco et al., 2014; Field, 2010; Goodman et al., 2015; Levendosky et al., 2018; Psychogiou et al., 2020; Shonkoff et al., 2012).In turn, these reduced quality parent-child relationships are linked to child/adolescent cognitive, behavioral (e.g., aggression, hyperactivity) and mental health (e.g., anxiety) problems, placing those affected on increased lifetime mental health risk trajectories (Beck, 1998; Devaney, 2015; Jung et al., 2007; Nicole Letourneau et al., 2019; Mueller & Tronick, 2019; Psychogiou et al., 2020; Shonkoff et al., 2012).A systematic review (Mesman et al., 2012)(n=30 studies) revealed that reduced parental sensitivity and responsiveness undermines: (1) children’s attachment security, and (2) children’s development, especially in cognitive and motor domains. Findings held across a diverse range of cultures (Mesman et al., 2012),including Canadian Indigenous peoples (Letourneau et al., 2005). Parental behaviors and cognitions that often accompany family violence (e.g. inconsistency in infant care, hostility) (Letourneau et al., 2007; Levendosky et al., 2003), or depression (e.g., fatigue, reduced concentration)may result in parents misreading or missing children’s cues (reduced sensitivity) and failing to provide feedback appropriate to meet children’s needs (reduced responsiveness) (Forman et al., 2007; Suchman et al., 2012). In general, children’s development and mental health is negatively impacted when parents are unable to: (1) recognize and respond appropriately to children’s cues that signal needs, and (2) regulate their children’s mental and emotional states (De Falco et al., 2014),two targets addressed in the Attachment and Child Health (ATTACH™) Online program. The ATTACH™ Online program is poised to address the long-lasting negative imprint on children’s development and mental health resulting from reduced parent-child relationship quality in at-risk families. Parent-Child Relationship Quality and Parental Reflective Function (RF) Sensitive and responsive parent-child relationships are in part, the result of parental RF(Steele & Steele, 2008)—parents’ capacity to understand their own and their child’s thoughts, feelings, mental states, and intentions. Higher parental RF is significantly associated with parent-child relationship quality, specifically parental involvement, communication, limit setting and support of the child, independent of other predictors including adult depression, partner relationship quality, and income (Rostad & Whitaker, 2016). Parental RF enables parents to appropriately regulate their own feelings and behavior as well as their child’s (Fonagy et al., 2018; Slade, 2005). Self-regulation is crucial for accurately perceiving and appropriately responding to a child’s cues for comfort, soothing or exploration (Fonagy & Target, 1997; Slade, 2005; A. Slade et al., 2005),and is characteristic of optimal parent-child relationships. For example, a parent who is unable to recognize their child’s fear of separation is not likely to reassure the child that they will return, nor regulate their child’s stress response effectively. Parents’ experiences of depression and family violence (Asen & Fonagy, 2012; Fischer-Kern et al., 2013),and related past traumas or adverse childhood experiences (e.g. histories of emotional, physical, or sexual abuse) (Lyons-Ruth, 2015; Madigan et al., 2007),predict parents’ negative and distorted representations of reality and frightened, frightening, or dissociated behaviors during interactions with their young children (Asen & Fonagy, 2012; Fischer-Kern et al., 2013; Lyons-Ruth, 2015; Madigan et al., 2007).These parents are at risk for reduced RF, and less sensitive and responsive parent-child relationships, leaving their children at risk for insecure attachment, and long-lasting negative developmental and mental health outcomes (Center on the Developing Child at Harvard University, 2016).These parents are the target of the ATTACH™ program. Preschool boys and girls often differ in their development and mental health (Mowlem et al., 2019; Peyre et al., 2019). A study of 3-year olds (n=1055) revealed that boys and girls differed on communication and fine motor skills assessed via the ASQ-3 (third edition, Peyre et al., 2019). Another study of 3-year olds (n=7179) showed that 12% of boys versus 6% of girls, demonstrated social-emotional problems assessed via the ASQ:Social-Emotional (SE; Eurenius et al., 2019; Vaezghasemi et al., 2020). Further, parents may interact differently with boys and girls, given context. For example, mothers affected by family violence often interact more positively with their daughters than sons (Smagur et al., 2017). Therefore, it is necessary to consider the impact of biological sex when examining impacts of intervention programs, such as ATTACH™, on children's development and mental health. RF-Focused Intervention: ATTACH TM Online Program Preserving and promoting optimal RF in parents who are experiencing adversities enables parents to appropriately attribute affective states to their children and respond accurately to meet their children’s needs, thus promoting sensitive and responsive parent-child relationships (Fonagy, 1991; Fonagy & Target, 1997; A. Slade et al., 2005). Therefore, targeting parental RF improvement may be an effective intervention in tackling the impacts of early adversities on children’s mental health and development—the focus of the ATTACH™ intervention. ATTACH™ Pilot Studies and Pilot Results We conducted a series of seven ATTACH TM pilot studies in two phases to examine the effectiveness and impacts of the in-person ATTACH™ program on parent-child relationships, attachment, parental RF, and child development. We employed randomized control trial and quasi-experimental design pilot studies, guided by the IDEAS (Innovate, Develop, Evaluate, Adapt, and Scale) Framework™ (Center on the Developing Child, 2016; Center on the Developing Child at Harvard University, 2010, 2016)that emphasizes adaptation of intervention methods to emerging information. ATTACH TM Facilitators were trained researchers with advanced education (doctoral and post-doctoral trainees). Both phases involved at-risk mothers and their preschool-aged children in an inner-city agency serving vulnerable low-income families and two-family violence shelters. Outcomes included: (1) parent-child relationship quality assessed via the Parent-Child Interaction Teaching Scale (PCITS) (Oxford & Finlay, 2013);(2) attachment security assessed via Ainsworth’s (Ainsworth et al., 1978) Strange Situation Procedure (SSP); (3) parental RF assessed via the Parental Reflection Function Questionnaire (Anis, Perez, et al., 2020; Luyten et al., 2017),or transcribed Parent Development Interviews (PDI) (Slade et al., 2004), coded with Peter Fonagy’s ‘gold standard’ RF scale (Fonagy et al., 1998); (4) children’s development assessed via the ASQ-3 (Bricker & Squires, 2009), and (5) children’s mental health assessed via the ASQ:SE (Squires et al., 2015), and Child Behavior Checklist (CBCL) (Achenbach & Rescorla, 2010).Analysis of covariance, independent and paired t- tests, and chi-square tests were undertaken as appropriate with one-tailed testing ( alpha=.05 ) for directional hypotheses. Pilots were powered to identify trends in data from the small pilot samples. In Phase 1, the first three pilot studies, ATTACH™ significantly improved children’s development (ASQ-3 personal-social development; d =.98) (Anis, Letourneau, et al., 2020), parent-child relationship quality ( d =.34-.95) (Anis, Letourneau, et al., 2020), and parental RF ( d =.51-2.0) (Letourneau, 2020). In Phase 2, the second set of four pilot studies, ATTACH™ significantly improved children’s development on the ASQ-3, specifically communication ( d =.76), personal-social (d=.44-.48), problem-solving ( d =.76), and fine motor skills ( d =.81) (Letourneau et al., 2023; N. Letourneau et al., 2019). It also improved parental RF ( d =.56-.65), children’s mental health, specifically CBCL total externalizing behavioral problems ( d =.64), attention ( d =.74), aggression, ( d =.50), and anxiety ( d =.62) and parents’ and children’s immune cell gene expression linked to reduced inflammation [F(1,1794)=4.26] (Ross et al., 2021).When findings were pooled across all seven pilots, ATTACH™ significantly improved parental RF (OR=2.3) and parent-child attachment security (OR=2.29) (Letourneau et al., 2023). Whether ATTACH™ Online produces the same impacts, remains to be studied with a large sample. Findings from the ATTACH™ in-person program are so compelling that the Harvard Center on the Developing Child named ATTACH™ one of its prestigious Frontiers of Innovation projects (https://developingchild.harvard.edu/innovation-application/frontiers-of-innovation). Integrated Knowledge Translation ( iKT) and Knowledge User Engagement. Our iKT (Bowen & Graham, 2013; Graham et al., 2018) and engagement activities with knowledge users, including parents, health care professionals, and administrators in agencies resulted in targeted ATTACH™ programming and material co-development, co-adaptation, and co-evaluation. Researchers and knowledge users collaborated throughout the pilot studies in project governance, priority setting, and conduct of research. The researchers and knowledge users employed level 3 engaged participation methods characterized by collaboration and community-based participatory research methods from regular meetings and meaningful opportunities for contribution (Goodman & Sanders Thompson, 2017; McCutcheon et al., 2019). Key ATTACH™ intervention goals were developed with health care professionals and administrators in partner agencies. Knowledge users in community agencies reported preferring parenting programs that emphasize RF; however, they were often deemed unrealistic and cost-prohibitive to implement as typically involving months to years of intervention or psychotherapy (Camoirano, 2017; Cicchetti et al., 2006; Letourneau et al., 2015). For example, one well-known RF-focused program begins prenatally and lasts for 2 or more years (Sadler et al., 2013; Arietta Slade et al., 2005). ATTACH™ was thus designed to be relatively short duration (ultimately 10 weeks reduced from 12 weeks based on parents input in pilots), and feasibly administered by professionals with undergraduate education in a health-related field, typical of partner agency staff. Agency knowledge users also indicated their typical clientele present with more than one early adversity (e.g., family violence, depression, and low-income). Further, RF-focused parenting programs often do not incorporate co-parents, defined as individuals who are a main source of parenting support (i.e., biological or step father, boyfriend, grandmother/father, other relative, friend or other support person, as appropriate) (Cowan et al., 2009; Kochanska & Kim, 2013). Co-parents often have an important role in buffering parents from the effects of toxic stress (Feeney & Collins, 2015; Giesbrecht et al., 2013; Letourneau, Tryphonopoulos, et al., 2012). Thus, ATTACH™ was co-designed in pilot work to: (1) help parents in complex circumstances affected by multiple stressors rather than narrowly defined stressors (e.g. substance misuse, Suchman et al., 2008) and (2) include a variety of co-parents, in recognition of typically observed family structures of clients seeking community services and support. Since the completion of the pilots, additional changes to the ATTACH™ program design derived from knowledge user engagement. To address the broad range of family structures served in partners’ agencies, including both sexes/self-reported genders of parents, ATTACH™ was adapted to the primary child caregiver (whether mother, father, grandparent, foster carer, cis-or trans-gender, etc.) and their source of co-parent support. As a result, ATTACH™ will be more applicable across diverse family units and more realistic for implementation in community agencies. Second, ATTACH™ materials were made more ethnically diverse by changing the manual images and employing a variety of cultures in illustrative examples of RF in families. Finally, the training of ATTACH™ Facilitators has been made more accessible through an online ‘ATTACH™ Teachable’ program for training and accrediting health care professionals to deliver the program (see https://attach.teachable.com/). This resulted in trademarking the ATTACH™ name. COVID-19 Challenge and Opportunity The COVID-19 pandemic placed unprecedented strain on families and children, the healthcare system, and researchers engaged in ongoing research with at-risk families. In adjusting to the ‘new normal’ of self-isolation and remote interactions from public health restrictions, the need for effective online health interventions became apparent (Brooks et al., 2020).Parents were reluctant to see health-service providers at home or clinic due to infection fears for themselves, their child and family. Agencies also reduced in-person service delivery to parents and children. Simultaneously, ATTACH™ knowledge users including agency staff and parents involved in the in-person ATTACH™ delivery reported that families were desperate to obtain safe support to assist them with parenting, compounded by increasing incidence of financial strain, family violence, and mental health problems (Forbes et al., 2021; Mueller & Tronick, 2019; Racine et al., 2021; Vindegaard & Benros, 2020; Wilson et al., 2020). Such challenges have contributed to burgeoning developmental and mental health problems in children (Cost et al., 2021; de Miranda et al., 2020). Providing accessible, evidence-based interventions to at-risk families in the post-pandemic recovery period may prevent children’s long-term development and mental health problems. Thus, the researchers/knowledge users sought to deliver ATTACH™ Online, rather than in-person and engaged ATTACH™ Facilitators and parents in user-engaged design of an online intervention and data collection approach for ATTACH™. Users preferred Zoom™ (Graucher et al., 2022) for intervention delivery and REDCap (www.project-redcap.org) (Komanchuk et al., 2023) for data collection and both were successfully pilot tested for feasibility with 10 families. Thus, ATTACH TM Online is poised to address social and health inequities, amplified by the pandemic, by promoting accessibility of parenting support for vulnerable families, including those in rural and remote regions. In summary, ATTACH™ significantly improves children’s development, mental health, parent-child relationships including attachment security, as well as parental reflective function, and immune function. The evidence based, accessible ATTACH TM Online was co-developed with parents and agency partners, has been pilot tested, and is ready for testing effectiveness and examining implementation. Many vulnerable children and their families in Alberta stand to benefit, paving the way for widespread post-pandemic implementation to prevent and address the rising incidence of children’s development and mental health problems. Project funding in the amount of $999,013 CAD was provided by the Canadian Institutes of Health Research from 2022-2027. Study Objectives {7} Informed by an iKT (Graham et al., 2018) approach (i.e. researcher/knowledge user collaboration, engagement in project governance, priority setting, and conduct of research) combined with engagement of knowledge users and parents (Alberta SPOR SUPPORT Unit, 2018; CIHR/SPOR, 2014; Graham et al., 2018; McCutcheon et al., 2019), we propose an effectiveness implementation hybrid (EIH) Type II study of ATTACH™ Online. The two objectives of this study are to evaluate: (1) effectiveness, and (2) implementation fidelity and uptake (Curran et al., 2012)of ATTACH™ Online in naturalistic, real-world settings, delivered by community partner agencies serving families affected by early adversity in Alberta. Objective 1: To assess the effectiveness of ATTACH™ Online on: (1a) the primary outcome of children’s development, and secondary outcomes of children’s mental health, parent-child relationships (including attachment quality), and parental reflective function by using validated measures before, immediately after, and 3 months after intervention, and (1b) different parent populations (for whom program works best/worst). Our primary hypothesis is ATTACH™ Online improves children’s development in the cognitive domains of communication, personal-social, and problem solving. Secondary hypotheses examine whether ATTACH™ Online improves children’s mental health, parent-child relationships, and parental RF. Objective 2: To assess implementationfidelity and uptake of ATTACH™ Online in community agencies serving at-risk families in Alberta, Canada using a validated measure and qualitative and quantitative methods during and after intervention. Trial Design { 8} This EIH Type II (Curran et al., 2012)study is comprised of a quasi-experimental design evaluation of the community-agency delivered ATTACH™ Online (with measurement pre-intervention, immediately post-intervention, and 3 months post-intervention) as well as an examination of implementation fidelity and uptake (May et al., 2018; May et al., 2009). Objective 1: ATTACH™ Online Effectiveness. A quasi-experimental design was selected to more closely approximates service delivery models in agencies that do not typically employ control groups. Moreover, given significant differences in randomized controlled trials and quasi-experimental pilot studies (Anis, Letourneau, et al., 2020; Anis, Ross, et al., 2022), any design employing wait-list controls was deemed unacceptable and even unethical by the team including parents, health care professionals, and administrators from engagement activities during the preparation of this proposal. A step-wedge design (Hemming et al., 2015)was also ruled out due to concerns with undue delays in receiving the ATTACH™ Online program. Nonetheless, evaluation of effectiveness of the online version of the program was deemed essential by the team to ensure generalizability of findings to this new intervention modality. Objective 2: ATTACH™ Online Implementation. Quantification of implementation fidelity and uptake of ATTACH™ Online will be undertaken (details below). Normalization Process Theory (NPT) will be used to explain factors that promote or inhibit implementation fidelity and uptake, and can inform strategies to support embedding implementation in practice (May et al., 2007; May et al., 2018; May et al., 2009).Developed in response to recognition of the large gap between intervention development and intervention use in health care—the ‘know-do gap’—NPT is intended to uncover factors that interfere with the routine or “normal” incorporation of interventions into health care (Murray et al., 2010). The model explores coherence, cognitive participation, collective action, and reflexive monitoring of knowledge users with respect to the implementation of a given intervention. Thus, NPT is ideal for guiding our qualitative semi-structured interviews and analyses. Findings on the mechanisms of ATTACH™ implementation will guide activities to promote the normalization and integration of the ATTACH™ Online into routine community care for parents and children at-risk. Methods: Participants, Interventions, and Outcomes Participants Objective 1: Parents, Co-Parents, and Children. Families including parents, their children under the age of 36 months, and their identified co-parenting support persons are our study population. Objective 2: Knowledge Users. These include parents, health care professionals, and administrators from community partner agencies who participate in receiving or delivering the ATTACH™ Online program. Stakeholder Engagement: Building on our pilot work, we systematically engage stakeholders in our study planning design. Stakeholders and researchers engaged in multiple meetings at formative stages. Together, we identified ATTACH™ Online agencies for training and delivery, made changes to the ATTACH™ Online program, designed terms of reference, and selected the outcomes of interest. Key stakeholders include the Principal Knowledge User (Reimer) and members of the Community Engagement Committee. Reimer is Executive Director of the Alberta Council of Women’s Shelters, the provincial network organization of women's domestic violence shelters in Alberta that serves 40 members operating 50 agencies. She connected the team with 7 participating shelters whose leaders (e.g., administrators such as Executive Directors and health and social service professionals) are key community knowledge users on the Community Engagement Committee. Other Community Engagement Committee members are agency leaders operating services for teen mothers or families affected by significant adversity and trauma, as well as parents with relevant personal experience. These team members will participate in project roll-out, may participate in interviews as participants, learn about implementation, and/or have opportunities to take part in ATTACH TM Online training and ultimately independent delivery and evaluation. GRIPP-2SF (Preston et al., 2023; Staniszewska et al., 2017) will be used to report on study engagement. Study Setting {9} Settings include approximately eight Alberta agencies serving culturally diverse clients (i.e., Caucasian, Black, Indigenous, People of Colour [BIPOC], and immigrants) affected by family violence, depression, and low-income. Eligibility Criteria {10} Objective #1: The study inclusion criteria are: (1) parents with children between birth to 32 months of age at enrollment (our age ceiling is 36 months, based on selection of age-appropriate tools for assessing children); (2) parents who agree to participate in the ATTACH™ Online program consisting of 10 weeks of one-hour per week parent training sessions; (3) parents who agree to bring a co-parent for 2 of the 10 sessions; and (4) parents who are proficient in speaking and reading English. Objective #2: Participants (i.e., parents, co-parents, community health and social service agency administrators, and health and social service providers) must be adults (18 years of age or older), proficient in speaking and reading English, and knowledgeable or experienced in parenting programs. Intervention {11a, 11b, 11c and 11d} To deliver the ATTACH™ Online program, health and social service professionals (knowledge users) in collaborating agencies are required to undergo 40 hours of online and in-person training with ATTACH™ Master Trainers (e.g., Hart), over 2-3 months. After completion of all requirements, these knowledge users are certified Facilitators, able to deliver the ATTACH™ Online program and collect evaluation data. They will deliver the intervention independently but supported by ATTACH™ Master Trainers. ATTACH™ Online sessions with parents take one hour, occur weekly over 10 weeks and include three components including discussions of: (1) Digital video recordings of 3–5-minute parent-child play sessions, (2) Hypothetical, mildly stressful situations (e.g., infant feeding challenges), and (3) Day-to-day real-life stressful situations of parents’ choosing (for details, see published papers: Anis et al., 2021; Anis, Letourneau, et al., 2020; Anis, Ross, et al., 2022; Letourneau et al., 2023; Letourneau, 2020). During sessions, certified ATTACH™ Facilitators explore the parents’ perceptions of themselves and their children’s thoughts, feelings, intentions, and mental states, to maximize opportunities to practice RF. For example, a mother may be asked to consider what may be happening in her mind and the mind of her child during a shared smile in the video recorded interaction. After establishment of a therapeutic relationship with the ATTACH TM Facilitators (typically after 6 sessions), parents invite their co-parenting support person to attend 2 sessions, usually sessions 7 and 9. Social support (e.g. information about community resources, emotional and affirmational support) is also provided as needed. Our goal is to have at least 2 health care professionals at each of the eight agencies trained to deliver the ATTACH™ Online program (for a total of 20 ATTACH TM Facilitators trained in online delivery). Outcomes {12 including 12.1, 12.2, 12.3, 12.4, and 12.5} A robust data collection protocol was developed during the ATTACH™ Online pilot, revealing that measures are feasible to effectively administer online and with REDCap (www.project-redcap.org). Objective 1 Primary Outcome Children’s Development. We will employ the parent-report ASQ-3 (Bricker & Squires, 2009) to assess newborn to 36-month-old children’s development. The ASQ-3 measures cognitive (i.e. communication, personal-social skills, problem solving) and motor (i.e. gross and fine) domains of development. The ASQ-3 is suitable for 1-66-month-olds, with questions assessing children’s abilities to undertake age-appropriate tasks. Summing items in each domain provides total scores (maximum 60) with higher scores indicating more optimal outcomes. The ASQ-3 has strong internal consistency reliability (82-.88), sensitivity (.86), specificity (.85) (Mackrides & Ryherd, 2011),and identifies children at risk for development problems (Lamsal et al., 2018) with age-appropriate cut-offs (i.e., delay) in each domain. Taking 10-15 minutes to complete, the ASQ-3 is typically administered in community agencies, thus both agencies and our pilot parents judged this measure acceptable and feasible. Objective 1 Secondary Outcomes Children’s Mental Health. We will employ the parent-report ASQ:SE (Squires et al., 2015) to assess newborn to 36-month-old children’s mental health. The ASQ:SE is suitable for 1-72-month-olds, with 30 items summed to assess social-emotional development, and lower scores indicating more optimal outcomes. The ASQ:SE exhibits good internal consistency reliability (.67-.91), sensitivity (.78), specificity (.84) (Squires et al., 2015), and provides age-appropriate cut-offs to indicate risk for mental health problems. Taking 10-15 minutes to complete, the ASQ:SE is typically administered in community agencies, thus both agencies and our pilot parents find these measures acceptable and feasible. Parent-Child Relationship Quality and Attachment will be measured with the PCITS (Oxford & Finlay, 2013) and ATTACH TM Pre-school Attachment Screening tool (APAS) developed for this study. The PCITS (Oxford & Finlay, 2013) is an observational binary measure of relationship quality in an everyday teaching situation, designed for children 36 months or younger. Considered the gold standard for the assessment of parent-child relationship quality, PCITS consists of 73 items categorized into 6 subscales including parental sensitivity to cues, responsiveness to distress, cognitive growth fostering, and socio-emotional growth fostering, child clarity of cues and responsiveness to parent as well as parent total, child total, and parent-child total scores. Reliability and validity are well established (Letourneau et al., 2018)and was a strong measure of intervention impact in our pilot studies (Anis, Letourneau, et al., 2020; N. Letourneau et al., 2019).The observation typically takes 5 minutes and is video recorded to enhance the accuracy of data coding. ATTACH™ facilitators who are health care professionals in agencies will be trained to administer the video recordings via Zoom™. A robust Zoom data collection protocol was developed during the ATTACH™ Online pilot study for PCITS. Coders, reliable at 90th percentile with the University of Washington and who retained >95% intra-rater reliability over the course of pilot studies on 10% of recoded videos, will code all video recorded interactions. Coders are trained and supervised by PI Letourneau who has been a certified PCITS trainer since 1996 and has consistently maintained reliability in the delivery of the PCITS. The ATTACH TM Pre-school Attachment Screening tool (APAS), designed to be used with children between 24 months – 60 months, is a tool developed to screen attachment behavior, based on coding a 5-minute free play session in which a primary caregiver (parent, guardian, or custodian) is asked to “frustrate” the child by removing the desired toy of interest from the child during a play session. Such frustration tasks are commonly used in studies that examine children’s emotion regulation [e.g., (e.g., Calkins et al., 2002; Calkins & Fox, 2002; Calkins & Johnson, 1998; Calkins et al., 1998; Goldsmith et al., 2008). During a 5-minute free play session, caregivers are instructed to ‘play with their child as they normally would’ for the first three minutes of the play session, and then after receiving a cue from the camera person (usually three tapping sounds made by tapping on the camera) the caregiver is signaled to remove and disallow the child from playing with a favored toy (by holding the item behind the caregiver’s back) for one minute to induce mild frustration in the child. Then after receiving another tapping cue from the camera person (usually three tapping sounds made by tapping on the camera) the caregiver is signaled to return the desired toy of interest to the child for the last minute of play. Coders focus on the child’s response during the frustration portion of the play session and how the caregiver may (or may not) repair the breach in the dyadic play. The child’s response to this stressful event provides valuable information about the caregiver/child relationship and the child’s attachment pattern. Trained coders observe the child’s response then classify the child’s attachment pattern as either secure (Type B) or insecure (Type A, C, D) by using similar coding indices of established attachment measures, namely the MacArthur preschool attachment coding system (MAC) as taught by Dr. William Whelan (Anis, Ross, et al., 2022), which has been adapted for older preschool-aged children from Mary Ainsworth’s Infant Strange Situation Procedure (SSP) (Ainsworth et al., 1978). Thus, the MAC and SSP serve as the foundational model. Parental RF. This will be assessed via the PRFQ (Rutherford et al., 2015) and is an 18-item measure, with subscales assessing: (1) pre-mentalizing (2) certainty about mental states, and (3) interest and curiosity about mental states. Higher scores indicate higher levels of parental RF. The PRFQ has good internal consistency (.7-.84) and takes 5 minutes to complete. Pilot testing revealed the PRFQ detected intervention impacts and was acceptable to parents. In our other work (Anis, Perez, et al., 2020), we show that scores on the PRFQ associate significantly (p<.05) with the gold standard Parental Development Interview (Slade et al., 2004)coded with Fonagy’s 11-point scale (Fonagy et al., 1998).Given the gold standard requires 1-2 hours per parent interview, followed by 1 hour to check automated transcriptions, and 3 hours of coding per interview (~6 hours total), the use of the PRFQ reduces parent burden, costs, and is feasible to implement in agencies. Objective 2 Primary Outcomes Implementation Fidelity Assessment ATTACH Online Implementation fidelity will be assessed via a published, validated, ATTACH™ specific fidelity tool (Anis et al., 2021)that was developed to assess health care professionals’ adherence and delivery of key ATTACH™ intervention elements (i.e., video feedback of parent-child interactions, real life stressful and hypothetical situation reviews). ATTACH Online Implementation fidelity will be assessed more broadly by NPT interviews with parents, health care providers, and agency administrators by eliciting participants’ perceptions of facilitators and barriers to achieving fidelity of delivery of ATTACH™ Online elements and potential strategies to promote fidelity. Objective 2 Secondary Outcomes Uptake of ATTACH Online by agency clients will be quantified as a percentage score based on the number of families delivered ATTACH TM by trained service providers, divided by the number of eligible families in a given agency. NPT interviews will further determine participants’ perceptions of facilitators and barriers to uptake and potential strategies to promote uptake. Participant Timeline {13} Objective 1: Pre-Intervention. ATTACH™ Online begins with collection of pre-intervention assessment data including observational and questionnaire sources. ATTACH™ Online. The program begins after the pre-intervention sessions are completed–usually the following week. ATTACH™ Online sessions are described above in {11}: Post-Intervention Phase. The ATTACH™ Online intervention must be complete before post-intervention assessment which includes parents’ providing observational and questionnaire data. Delayed Post-Intervention . Three months after the post-intervention data collection is complete, parents will be reassessed, providing questionnaire data. Objective 2: To describe implementation fidelity and uptake of the ATTACH™ Online intervention and to explore the mechanisms influencing these outcomes with respect to coherence, cognitive participation, collective action, and reflexive monitoring, recruitment for participation in NPT interviews will begin shortly after the first family completes the ATTACH™ Online program (likely in Spring, 2024). Recruitment will continue until data saturation is attained, i.e., the degree to which new data repeats or is redundant with what was expressed in previous data (Patton, 2002; Saunders et al., 2018). We will employ a stopping rule. Data collection in a category (parent, health care professional, and administrator) will cease when three interviews in a row offer less than 10% new information (i.e., only one question of the 13-15 interview guide questions offers new information). Sample Size {14 including 14.1} Objective 1: Quantitative component. We will examine pre-intervention/post-intervention differences from the primary outcome of development, and our secondary outcomes of children’s mental health, parent-child relationship and attachment quality and parental RF with 100 parents and children (aged newborn to 36 months). We will recruit 100 families, to attain a sufficiently powered N of 80 families with complete data, assuming up to 20% incomplete data. This is based on power of .90, and two-tailed alpha ( p <.05/3=.0167, given Bonferroni correction applied for separate comparisons using three developmental outcomes). Pilot data from the in-person ATTACH™ program tests revealed relevant effect sizes for child development, ranging from d =.44-.98 for communication, personal social, problem-solving skills (Anis, Letourneau, et al., 2020; Anis, Ross, et al., 2022; Letourneau et al., 2023). Thus, eighty complete participant family data sets will be sufficient to detect conservatively moderate effect sizes for within group differences ( d =.44) for each of the three developmental outcomes (communication, personal-social, problem-solving) between pre-intervention and immediately post-intervention. Multiple discussions with agency knowledge users give confidence that it will be feasible to recruit an average of 8-10 families (including parents, co-parents, and children) from each agency from rosters of parents currently seeking service and to retain them for 3 months post-intervention for follow-up. Any longer was deemed unrealistic given potential for parent relocation. Objective 2 ATTACH™ Online Implementation. From discussions with agency administrators, it will be feasible to recruit 20 parents, 20 health and social service providers, and 20 administrators (total n= 60) for interviews. However, recruitment and data collection will continue only until data saturation (Anis, Letourneau, et al., 2020; Straus & Douglas, 2004). Recruitment {15} Objective 1: ATTACH TM Online Effectiveness . Every partner agency will recruit 2-5 staff members for ATTACH™ Online training to become the ATTACH™ Facilitators. To partake in ATTACH™ Online, participants will be identified through partner agencies. We will recruit up to 100 parents and their newborn to 36-month-old children to retain 80 complete pre- and post-intervention data from approximately eight Alberta agencies. Parents will be recruited from rosters of parents currently seeking services at these agencies. ATTACH TM Online information sheets and brochures will be posted on agency implementation sites. Agency staff will assist with recruitment as participants seek their services in routine care. Objective 2: ATTACH TM Online Implementation. Parents,health and social service providers, and administrators from each of the 10 agencies will be recruited via convenience sampling methods. Methods: Data Collection, Data Management, Statistical Methods, Monitoring, and Analysis Data collection methods {18a (18a.1, 18a.2) 18b} Objective 1: ATTACH™ Online Effectiveness. Knowledge users at agencies and researchers agreed to reduce parent burden from data collection. Thus, demographic data will be obtained from agency administrative records as much as possible, e.g., ethnicity, sex, gender, first language, marital status, education, employment, number of children, and age (parents and children) at baseline. To further reduce burden, many measures have been selected from intake data collection already conducted in agencies, e.g., ASQ-3 (Bricker & Squires, 2009). We will include covariate measures of adversities that are often administered at parent intake for: (1) Depressive symptoms with the Edinburgh Depression Scale (EDS) (Cox et al., 1987; Matthey et al., 2006),a 10-item self-report tool to measure depression with sensitivity of 66.7-69% and specificity of 67.7% that takes 5 minutes to administer, (2) Family violence with the Revised Conflict Tactics Scale-Short Form (CTS2-SF) (Straus & Douglas, 2004), a 20-item questionnaire with internal consistency of .79-.95 that takes 3 minutes to complete, and (3) Parents’ adverse childhood experiences with the Adverse Childhood Experiences (ACE) (Felitti & Anda, 2009)Questionnaire, consisting of 10 questions, with extensive reliability and validity data that takes less than 3 minutes to complete. To assess the covariate of parent strengths in the face of adversity, the Brief Resilience Scale (BRS) (Smith et al., 2008)will also be administered, a 6-item tool with internal consistency ranging from .80-.91 that takes 3 minutes to complete. All questionnaire data will be collected at baseline, immediately post-intervention, and 3 months post-intervention by agency health care professionals/ATTACH™ facilitators, who will be trained and supervised to collect questionnaire data via REDCap (www.project-redcap.org) using iPads provided during the ATTACH™ training. Objective 2: ATTACH™ Online Implementation. Basic demographic data will be collected from knowledge users, including age, sex, gender, employment, and education. Fidelity will be assessed via the published, validated, ATTACH™-specific fidelity tool (Anis et al., 2021)completed by health care professionals after every ATTACH™ interaction with parents. Uptake-relevant data will be collected from agency administrators via a brief survey including their demographic information. NPT interviews will further examine implementation fidelity and uptake and mechanisms to promote more optimal delivery of ATTACH™ Online. These will begin shortly after the initially enrolled parents complete the intervention and continue until data saturation. An NPT-guided interview was created to assess implementation and finalized with input from knowledge users engaged in review, feedback and decision making and pilot tested before use. Interviews will be digitally audio recorded with Zoom (Graucher et al., 2022) and automatically transcribed verbatim with Otter.ai (Lee et al., 2022; Mahdi, 2021),and checked for accuracy, with privacy protections in place to guard participant identity and personal information. Data Management {19} Partner agencies will collect the data via iPads with REDCap software installed, as per best practice recommendations (Garcia & Abrahão, 2021; Komanchuk et al., 2023; Rivera et al., 2021).Agency health and social service providers/ATTACH™ Online Facilitators will be trained and supervised to employ the iPads and REDCap as part of the ATTACH™ Online Training Program. Partner agency health and social service providers/ATTACH TM Online facilitators will be provided with a login information to access the baseline, immediate post-intervention, and delayed post-intervention questionnaires. After logging in, Facilitators will ask the participant to fill out the questionnaires, which will only request de-identified data (except for required linkage to consent, filed separately); data will be automatically shared to the REDCapwebsite after completion. Any data sharing or communication from the partner agencies will be done via the University of Calgary domain specific email account. Digital video data will be saved on the iPads and uploaded to secure Box on the cloud (https://www.box.com/en-ca/capture). The staff at the local agencies will be trained to delete any digital data from the iPads. Digital copies of transcripts and audio files will be kept in a secure network location administered by the University of Calgary’s Information Technology services and accessible only to the research team. All the information contained in our analyses and summaries will be anonymous and based on group data. Published reports will not identify participants by name, address, agency, or any other personal information. Furthermore, all research team members are aware of the importance of maintaining participant anonymity and are required to sign a confidentiality agreement. Statistical Methods {20a (20a.1), 20b and 20c} We will analyze the demographic characteristics of the sample with measures of central tendency and frequencies as appropriate. Alpha will be set a priori at .05 (two-tailed) unless testing directional hypothesis (one-tailed). Objective 1: ATTACH TM Online Effectiveness . For(1a), to evaluate ATTACH TM Online program effects on children’s development (primary outcome), children’s mental health, parent-child relationship and attachment quality, and parental RF (secondary outcomes) immediately post-intervention and at 3 months post-intervention, we will employ repeated measures analysis of variance (ANOVA), paired-t-tests, and chi-square tests to examine outcomes between baseline, immediate post-intervention, and delayed post-intervention assessments. We will undertake three sets of analyses for our primary hypotheses tests. For (1b) to determine whether ATTACH TM Online is equally effective across parent populations (and for whom it works best/worst), we will examine differences among sub-groups derived from known covariates through use of independent samples t -tests (two groups, e.g., child sex), ANOVAs (more than 2 groups, e.g., race/ethnicity), repeated measures analysis of covariance (with identified covariate) and linear regression models (continuous covariate, e.g., age, years of education). Additionally, we will consider child sex as a covariate and stratification variable in our analyses. We will include both mothers and fathers in the ATTACH TM Online implementation and examine impacts on parents as a group, with separate analyses for mothers and fathers, even though fathers are likely to be far fewer in number than mothers. (One of our partner agencies serves many fathers). We will also consider gender in our analyses. Parents will report the gender that they identify with, preferred pronoun, and preferred term for themselves as a parent, e.g. mother, father, or another word. While insufficient numbers will likely limit interpretability, we will consider parents’ characterizations as cis-, trans-gender, or gender-diverse in analyses. For children, while it is unlikely that preschoolers will be non cis-gender, we will consider parent-reported child gender in our analyses, to the degree possible. These analyses will help determine how the ATTACH TM Online may affect different sex and gender-based patient populations. Objective 2: ATTACH TM Online Implementation . The fidelity assessment tool will be quantified by evaluating adherence to program content elements; each element is coded as Yes (attempted= implemented as intended) or No (not attempted = never asked or failed to perform) (Anis et al., 2021). To be considered satisfactory, content fidelity is expected to be 90% or higher for Yes category, or 10–20% or lower for No category (Anis et al., 2021). After all participants have been recruited, uptake data will be calculated with scores applied to each agency. Data on variables such as health care professionals’ years of experience, age, gender will be collected and considered for their impacts on fidelity and uptake. Qualitative analysis of NPT interviews will involve the stages of thematic analysis including familiarization, coding, theme development, and data reporting (Terry et al., 2017). Theme and sub-theme development will be deductive, using a priori codes dictated by interview questions to explain factors that promote or inhibit the intervention from being embedded in agency practice. Two trainees will code the data, supervised by PI Letourneau, who is experienced in qualitative data analysis. Coding will inform when data saturation is reached. Data will be managed with Dedoose (Sociocultural Research Consultants, 2021). Data from parents, service providers, and administrators will be coded separately, and coding trees examined for similarities and differences post-hoc . Once themes and sub-themes are finalized, findings summarized in draft reports will be shared with key informants as a validation check (Richards, 2005). Data from parents, service providers, and administrators will be coded separately, and coding trees examined for similarities and differences post-hoc . Methods: Monitoring Data Monitoring {21a, 21b} Because this is a social intervention, not a drug or pharmaceutical trial, there is no data monitoring committee or interim analysis (Anis, Letourneau, et al., 2022). Harms {22} Observed incidents such as mental health crises, will be documented and managed as necessary by agency personnel delivering ATTACH™ Online (e.g., by providing appropriate comfort measures as well as mental health referrals). It is important to note that ATTACH™ facilitators are also employees of health and social service agencies who serve the clients/participants. If the investigators or ATTACH™ facilitators interacting with these families observe child abuse, they will report it to the Law Enforcement Authorities, as is required by law. Auditing {23} As ATTACH TM is a social intervention rather than a drug or pharmaceutical trial, there is no data auditing (Anis, Letourneau, et al., 2022). Ethics and Dissemination Research Ethics App roval and Consent or Assent {24 and 26a} Ethics approval has been obtained from the Conjoint Health Research Ethics Board (CHREB; Ethics ID: REB20-0903) of the University of Calgary, and all participants will undergo a process seeking their informed consent. The University of Calgary is the lead agency conducting this study and partner agency research sites rely on CHREB’s approval as part of their agency ethics protocols. All funding and research guidance flows from the University of Calgary and while partner agencies will typically not have access to the study data, nor have direct involvement in data analysis or data storage, some knowledge users involved in the project may become more involved, requiring their addition to the ethics file as needed with all appropriate safeguards for participant safety, anonymity, and confidentiality maintained. All participants will be asked to provide informed consent. The process of informed consent involves verbal consent secured at each stage of the process, including recruitment, screening, intervention, and data collection. Participants will be provided with an electronic consent form for their signature. This will be retained by the study investigators and participants will receive a signed copy. We have created different consent forms for the and intervention participation and individual interviews to clearly indicate to what participants are consenting (see Appendix 1; Appendix 2). The voluntary nature of the study will be reinforced verbally throughout the consent process and, indeed, throughout the course of the participants’ involvement in the study data collection. They may choose not to answer some questions, or to withdraw from the study at any time without affecting their receipt of the ATTACH™ Online program, health care or other partner agencies’ services. If they choose to no longer participate (at any time including once data analysis has begun), we will retain their data for attrition analyses, unless asked explicitly to remove data from the study, in which case we will attain the participants’ unique numeric identification (see below, Confidentiality) and delete all relevant data. Staff at the participating agencies will avoid any coercion by letting the potentially interested families know that their participation is completely voluntary, and that they can withdraw any time. Access to agency services will not be affected by participation or withdrawal. Ethics approval has been received for an adaptive honorarium schedule of gift cards that provides increased compensation commensurate with increased parent burden. This schedule emerged from numerous collaborative conversations with parents and agency health and social service administrators and providers. Study participants will be offered $100.00 in Amazon gift cards in increasing value over 10 sessions. Moreover, each NPT interviewee will be given a $30 gift card, in compensation for a 60–90-minute NPT interview. Protocol amendments {25} There have been no amendments to the protocol. Consent or assent {26b} In ancillary studies, participants' data and biological specimens are not subject to additional consent provisions. Confidentiality {27} All data will be held confidentially and stored on a secure network drive. To ensure anonymity, participants will be assigned unique numeric codes in place of names. There will be no use of personal email accounts or emails for communication or for sharing of data. To ensure that participants understand the privacy and confidentiality nature of the study, the staff will ensure that they sign the consent form at the beginning of the study. Additional steps may include reiterating the privacy and confidentiality nature of the study before initiating the video recording. The partner agencies will collect demographic information about parents, such as their name and age. Apart from the consent form (stored separately), partner agencies will only share de-identified data associated with participants’ unique numeric codes, with the ATTACH TM Online Team. The demographic information will be used to describe our sample in our future publications. The interactions between the parents and children will be video recorded for the purpose of assessing the quality of parent-child interaction and attachment. These assessments are based on age and any video data that is digital will be password protected and encrypted. Participants will only be identified by an ID number, so researchers will not have access to any identifying information. Any identifying information will be removed from the beginning and replaced with an ID number for analysis. Only the research team will have access to questionnaire response data. All information provided by participants will be kept confidential, except when it needs to be reported as required by law (such as when participants express a desire to do harm to themselves or others). Participants will not be identified in any publications or presentations that result from this research. The findings will be presented at health conferences and published in scientific journals as aggregate data. Any information that could identify participants will not be included. Declaration of interests {28} No competing interests are declared by the authors. Access to data {29} Data used and/or analyzed during this study may be made available by the corresponding author upon request and in compliance with the University of Calgary and ATTACH TM Online program research collaboration and data transfer guidelines. Dissemination policy {31a, 31b, 31c} Our team including researchers and the Community Engagement Committee members, will generate an array of dissemination products, including traditional high-impact peer-reviewed papers and presentations as well as innovative products such as in-services, infographics, and opinion-editorials. Principal knowledge user Reimer will share progress/findings in the network of Women’s Shelters in Alberta, promoting widespread ATTACH TM Online program uptake. We will continue our ongoing ATTACH™ webinar series (see https://attach.teachable.com/ p/webinar-series), sharing progress and emerging findings with a wide audience. Publications will adhere to CIHR’s open access policy (http://www.cihr-irsc.gc.ca/e/46068.html) as well as CIHR’s sex and gender-based analysis policy (http://www.cihr-irsc.gc.ca/e/ 50833.html). Reporting guidelines will be employed in published papers, e.g., Consolidated Standards of Reporting Trials (CONSORT) (Antes, 2010; Schulz et al., 2010), Template for Intervention Description and Replication (TIDieR) checklist (Hoffmann et al., 2014), GRIPP-2SF (Preston et al., 2023; Staniszewska et al., 2017), and Consolidated Criteria for Reporting Qualitative (COREQ) (Tong et al., 2007) research. Discussion Harvard University’s Center on the Developing Child suggests that achieving improved development and mental health of children exposed to early adversity (e.g. family violence) requires effective early interventions focused on supporting parent-child relationships (Center on the Developing Child, 2016 ; Center on the Developing Child at Harvard University, 2010 , 2016 ). Interventions that focus on promoting parental RF in the context of parent-child relationships have perhaps the greatest potential to improve development and mental health for these at-risk children (Letourneau et al., 2015 ; Ordway et al., 2015 ). Should the findings reveal effectiveness and mechanisms for ATTACH™ that facilitate implementation fidelity and uptake, efforts will be undertaken to spread and scale ATTACH™ Online across Alberta, and ultimately Canada and globally, addressing societal health inequities that begin in early childhood from exposure to adversities. We have thoroughly pilot tested all approaches and the current study will evaluate of the effectiveness of ATTACH™ Online with a larger sample. Our naturalistic design and deliverables are feasible, based on past and planned engagement and extensive pilot work, and partnership with agencies delivering the program in the context of their services for families affected by adversities. Findings on the mechanisms of ATTACH™ implementation will guide activities to promote the normalization and integration of the ATTACH™ Online into routine community care for parents and children at-risk of developmental and mental health problems. Successful implementation of ATTACH™, delivered online, has the potential to promote health equity of families affected by toxic stress and could serve as a population health strategy (Organization, 2022 ). Status of Trial: Recruitment in progress; start date of recruitment: Fourth-quarter, 2022 Declarations Ethics Approval and Consent to Participate Ethics approval has been obtained from the Conjoint Health Research Ethics Board (CHREB; Ethics ID: REB20-0903) of the University of Calgary, and all participants will undergo a process of informed consent. The University of Calgary is the lead agency conducting the study and partner agency research sites rely on CHREB’s approval as part of their agency ethics protocols. All funding and research guidance flows from the University of Calgary and partner agencies will not have access to the study data, nor will they be involved in data analysis or data storage. The participants will be asked to provide informed consent. We have created different consent forms for the individual interviews and intervention participation to clearly indicate to parents what they are consenting to participate in (see Appendix 1 and 2). Consent to Publish Not applicable. Availability of Data and Materials The datasets used and/or analyzed during this study can be made available by the corresponding author upon request and in accordance with the research collaboration and data transfer guidelines of the University of Calgary and the ATTACH TM Online researchers. Materials including all relevant raw data, will be freely available to any scientist wishing to use them for non-commercial purposes, without breaching participant confidentiality. Competing Interests The authors MH and NL are co-owners of the for-profit and not-for-profit companies engaged in delivering ATTACH™. All other authors have no competing interests to report. Adherence to national and international regulations Not applicable. Author Contribution Conceptualization: NL, LA, CC, IDG, KR, KN, JR, MP, EW, SL, SV, MJS, AS, AS, BT, LH, TB, and MH.Literature review: NL, LA, CC, IDG, KR, KN, JR, MP, EW, SL, SV, MJS, AS, AS, BT, LH, TB, and MH. Study Protocol Development: NL, LA, CC, IDG, KR, KN, JR, MP, EW, SL, SV, MJS, AS, AS, BT, LH, TB, and MH.Validation: NL, LA, CC, IDG, KR, KN, JR, MP, EW, SL, SV, MJS, AS, AS, BT, LH, TB, and MH. Writing—original draft preparation: NL, LA, CC, IDG, KR, KN, JR, MP, EW, SL, SV, MJS, AS, AS, BT, LH, TB, and MH. Writing—review and editing: NL, LA, CC, IDG, KR, KN, JR, MP, EW, SL, SV, MJS, AS, AS, BT, LH, TB, and MH. Resources: NL, LA, CC, IDG, KR, KN, JR, MP, EW, SL, SV, MJS, AS, AS, BT, LH, TB, and MH. 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Services","correspondingAuthor":false,"prefix":"","firstName":"Tiffany","middleName":"","lastName":"Beks","suffix":""},{"id":330595278,"identity":"4b14492d-e609-4f9f-9961-c4e31ddcc489","order_by":17,"name":"Martha Hart","email":"","orcid":"","institution":"University of Calgary","correspondingAuthor":false,"prefix":"","firstName":"Martha","middleName":"","lastName":"Hart","suffix":""}],"badges":[],"createdAt":"2024-05-27 23:48:01","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4487245/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4487245/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12887-024-05232-w","type":"published","date":"2025-04-09T16:05:38+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":80558672,"identity":"5f144137-7cd5-4a6d-b385-2b8c9f70e7e1","added_by":"auto","created_at":"2025-04-14 16:15:56","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1579139,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4487245/v1/33939224-f46a-4b0f-9fd3-0268a9a05f44.pdf"},{"id":61973939,"identity":"02a0b7cf-605c-4d82-ba44-0262aba5c9ac","added_by":"auto","created_at":"2024-08-07 17:49:05","extension":"pdf","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":230067,"visible":true,"origin":"","legend":"","description":"","filename":"FillableSPIRITOutcomes2022ChecklistwithSPIRIT2013.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4487245/v1/3885566aa0da97e4b9d1f1e7.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eStudy Protocol for Assessing the Effectiveness, Implementation Fidelity and Uptake of Attachment \u0026amp; Child Health (ATTACHTM) Online: Helping Children Vulnerable to Early Adversity\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003e\u003cstrong\u003eBackground and Rationale {6a and 6b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eImpact of Early Adversities on Parent-Child Relationships and Children\u0026rsquo;s Development and Mental Health\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eExposure to early adversities such as family violence, parental depression, and low income, undermine children\u0026rsquo;s development and mental health\u0026nbsp;(Bucci et al., 2016; Center on the Developing Child at Harvard University, 2010; Frameworks Institute, 2005; Shonkoff et al., 2012), with costs to society from lower school achievement, under-employment, and higher rates of chronic disease and mental health problems, over the lifespan\u0026nbsp;(Bethell et al., 2014). Alarmingly, 50-70% of adult mental health problems stem from exposure to these early adversities\u0026nbsp;(Jones, 2013; Kim-Cohen et al., 2003; Merikangas et al., 2009; Van Os et al., 1997). Impacts are observed in early childhood in the form of compromised cognitive development (e.g., communication, and personal-social, and problem-solving skills) and physical health (e.g., motor skills)\u0026nbsp;(Kuehn, 2014; Shonkoff et al., 2012). Drawing from large population surveys in Alberta (n~5000), more than 25% of preschool-aged children are raised in families with at least one early adversity\u0026nbsp;(Alberta Education, 2014; Metcalf A et al., 2011; Province of Alberta, 2011).Family violence occurs in 4% of childbearing families in Canada, a statistic believed to be low due to underreporting\u0026nbsp;(Burczycka \u0026amp; Conroy, 2018).\u003c/p\u003e\n\u003cp\u003eNegative impacts of exposure to family violence on children\u0026rsquo;s development and mental health are well established\u0026nbsp;(Graham-Bermann et al., 2009; Jenney \u0026amp; Alaggia, 2018; Piotrowski \u0026amp; Letourneau, 2020; Vameghi et al., 2016).For example, 1- to 3-year-olds exposed to family violence experienced significant cognitive (i.e., problem-solving) and fine motor skill delays, assessed via the Ages and Stages Questionnaire (ASQ) \u0026ndash; second edition \u0026nbsp;(ASQ-2; n=51)\u0026nbsp;(Letourneau et al., 2013).Similarly, 6- to 18-month-old children exposed to family violence experienced cognitive delays (i.e., communication, personal-social, and problem-solving skills) and gross and fine motor delays assessed via the ASQ-2 (n=750). Parental depression is also well-known to negatively impact children\u0026rsquo;s development and mental health\u0026nbsp;(Abdollahi et al., 2017; Letourneau, Dennis, et al., 2012; Letourneau et al., 2017).For example, exposed 12- and 24-month-olds (n=1555) had significantly reduced cognitive development characterized by lower ASQ-2 communication scores\u0026nbsp;(Valla et al., 2016),and exposed 2- to 6-year-olds (n=2231) had reduced ASQ-2 cognitive and gross motor developmental scores\u0026nbsp;(Tuovinen et al., 2018).\u0026nbsp;Depression affects 7-19% of mothers\u0026nbsp;(Gavin et al., 2005; Howard et al., 2014)\u0026nbsp;and 10% of fathers\u0026nbsp;(Paulson \u0026amp; Bazemore, 2010)caring for children under three years of age. Nine percent of Canadian children live below the poverty line\u0026nbsp;(Statistics Canada, 2019).Similar impacts of low-income on children\u0026rsquo;s ASQ development scores have also been observed\u0026nbsp;(Potijk et al., 2013; Wei et al., 2015).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Early adversities compromise parent-child relationships, characterized by reduced parental sensitivity/responsiveness, and insecure parent-child attachment\u0026nbsp;(De Falco et al., 2014; Field, 2010; Goodman et al., 2015; Levendosky et al., 2018; Psychogiou et al., 2020; Shonkoff et al., 2012).In turn, these reduced quality parent-child relationships are linked to child/adolescent cognitive, behavioral (e.g., aggression, hyperactivity) and mental health (e.g., anxiety) problems, placing those affected on increased lifetime mental health risk trajectories\u0026nbsp;(Beck, 1998; Devaney, 2015; Jung et al., 2007; Nicole Letourneau et al., 2019; Mueller \u0026amp; Tronick, 2019; Psychogiou et al., 2020; Shonkoff et al., 2012).A systematic review\u0026nbsp;(Mesman et al., 2012)(n=30 studies) revealed that reduced parental sensitivity and responsiveness undermines: (1) children\u0026rsquo;s attachment security, and (2) children\u0026rsquo;s development, especially in cognitive and motor domains. Findings held across a diverse range of cultures\u0026nbsp;(Mesman et al., 2012),including Canadian Indigenous peoples\u0026nbsp;(Letourneau et al., 2005).\u003c/p\u003e\n\u003cp\u003eParental behaviors and cognitions that often accompany family violence (e.g. inconsistency in infant care, hostility)\u0026nbsp;(Letourneau et al., 2007; Levendosky et al., 2003), or depression (e.g., fatigue, reduced concentration)may result in parents misreading or missing children\u0026rsquo;s cues (reduced sensitivity) and failing to provide feedback appropriate to meet children\u0026rsquo;s needs (reduced responsiveness)\u0026nbsp;(Forman et al., 2007; Suchman et al., 2012). In general, children\u0026rsquo;s development and mental health is negatively impacted when parents are unable to: (1) recognize and respond appropriately to children\u0026rsquo;s cues that signal needs, and (2) regulate their children\u0026rsquo;s mental and emotional states\u0026nbsp;(De Falco et al., 2014),two targets addressed in the Attachment and Child Health (ATTACH\u0026trade;) Online program. The ATTACH\u0026trade; Online program is poised to address the long-lasting negative imprint on children\u0026rsquo;s development and mental health resulting from reduced parent-child relationship quality in at-risk families.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParent-Child Relationship Quality and Parental Reflective Function (RF)\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSensitive and responsive parent-child relationships are in part, the result of parental RF(Steele \u0026amp; Steele, 2008)\u0026mdash;parents\u0026rsquo; capacity to understand their own and their child\u0026rsquo;s thoughts, feelings, mental states, and intentions. Higher parental RF is significantly associated with parent-child relationship quality, specifically parental involvement, communication, limit setting and support of the child, independent of other predictors including adult depression, partner relationship quality, and income\u0026nbsp;(Rostad \u0026amp; Whitaker, 2016). Parental RF enables parents to appropriately regulate their own feelings and behavior as well as their child\u0026rsquo;s\u0026nbsp;(Fonagy et al., 2018; Slade, 2005). Self-regulation is crucial for accurately perceiving and appropriately responding to a child\u0026rsquo;s cues for comfort, soothing or exploration\u0026nbsp;(Fonagy \u0026amp; Target, 1997; Slade, 2005; A. Slade et al., 2005),and is characteristic of optimal parent-child relationships. For example, a parent who is unable to recognize their child\u0026rsquo;s fear of separation is not likely to reassure the child that they will return, nor regulate their child\u0026rsquo;s stress response effectively.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Parents\u0026rsquo; experiences of depression and family violence\u0026nbsp;(Asen \u0026amp; Fonagy, 2012; Fischer-Kern et al., 2013),and related past traumas or adverse childhood experiences (e.g. histories of emotional, physical, or sexual abuse)\u0026nbsp;(Lyons-Ruth, 2015; Madigan et al., 2007),predict parents\u0026rsquo; negative and distorted representations of reality and frightened, frightening, or dissociated behaviors during interactions with their young children\u0026nbsp;(Asen \u0026amp; Fonagy, 2012; Fischer-Kern et al., 2013; Lyons-Ruth, 2015; Madigan et al., 2007).These parents are at risk for reduced RF, and less sensitive and responsive parent-child relationships, leaving their children at risk for insecure attachment, and long-lasting negative developmental and mental health outcomes\u0026nbsp;(Center on the Developing Child at Harvard University, 2016).These parents are the target of the ATTACH\u0026trade; program.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePreschool boys and girls often differ in their development and mental health\u0026nbsp;(Mowlem et al., 2019; Peyre et al., 2019). A study of 3-year olds (n=1055) revealed that boys and girls differed on communication and fine motor skills assessed via the ASQ-3\u0026nbsp;(third edition, Peyre et al., 2019). Another study of 3-year olds (n=7179) showed that 12% of boys versus 6% of girls, demonstrated social-emotional problems assessed via the ASQ:Social-Emotional\u0026nbsp;(SE; Eurenius et al., 2019; Vaezghasemi et al., 2020). Further, parents may interact differently with boys and girls, given context. For example, mothers affected by family violence often interact more positively with their daughters than sons\u0026nbsp;(Smagur et al., 2017). Therefore, it is necessary to consider the impact of biological sex when examining impacts of intervention programs, such as ATTACH\u0026trade;, on children\u0026apos;s development and mental health.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRF-Focused Intervention: ATTACH\u003csup\u003eTM\u003c/sup\u003e Online Program\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePreserving and promoting optimal RF in parents who are experiencing adversities enables parents to appropriately attribute affective states to their children and respond accurately to meet their children\u0026rsquo;s needs, thus promoting sensitive and responsive parent-child relationships\u0026nbsp;(Fonagy, 1991; Fonagy \u0026amp; Target, 1997; A. Slade et al., 2005). Therefore, targeting parental RF improvement may be an effective intervention in tackling the impacts of early adversities on children\u0026rsquo;s mental health and development\u0026mdash;the focus of the ATTACH\u0026trade; intervention. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eATTACH\u0026trade; Pilot Studies and Pilot Results\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe conducted a series of seven ATTACH\u003csup\u003eTM\u003c/sup\u003e pilot studies in two phases to examine the effectiveness and impacts of the in-person ATTACH\u0026trade; program on parent-child relationships, attachment, parental RF, and child development. We employed randomized control trial and quasi-experimental design pilot studies, guided by the IDEAS (Innovate, Develop, Evaluate, Adapt, and Scale) Framework\u0026trade;\u0026nbsp;(Center on the Developing Child, 2016; Center on the Developing Child at Harvard University, 2010, 2016)that emphasizes adaptation of intervention methods to emerging information. ATTACH\u003csup\u003eTM\u003c/sup\u003e Facilitators were trained researchers with advanced education (doctoral and post-doctoral trainees). Both phases involved at-risk mothers and their preschool-aged children in an inner-city agency serving vulnerable low-income families and two-family violence shelters. Outcomes included: (1) parent-child relationship quality assessed via the Parent-Child Interaction Teaching Scale (PCITS)\u0026nbsp;(Oxford \u0026amp; Finlay, 2013);(2) attachment security assessed via Ainsworth\u0026rsquo;s\u0026nbsp;(Ainsworth et al., 1978)\u0026nbsp;Strange Situation Procedure (SSP); (3) parental RF assessed via the Parental Reflection Function Questionnaire\u0026nbsp;(Anis, Perez, et al., 2020; Luyten et al., 2017),or transcribed Parent Development Interviews (PDI)\u0026nbsp;(Slade et al., 2004), coded with Peter Fonagy\u0026rsquo;s \u0026lsquo;gold standard\u0026rsquo; RF scale\u0026nbsp;(Fonagy et al., 1998); (4) children\u0026rsquo;s development assessed via the ASQ-3\u0026nbsp;(Bricker \u0026amp; Squires, 2009), and (5) children\u0026rsquo;s mental health assessed via the ASQ:SE\u0026nbsp;(Squires et al., 2015), and Child Behavior Checklist (CBCL)\u0026nbsp;(Achenbach \u0026amp; Rescorla, 2010).Analysis of covariance, independent and paired \u003cem\u003et-\u003c/em\u003etests, and chi-square tests were undertaken as appropriate with one-tailed testing (\u003cem\u003ealpha=.05\u003c/em\u003e) for directional hypotheses. Pilots were powered to identify trends in data from the small pilot samples.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn Phase 1, the first three pilot studies, ATTACH\u0026trade; significantly improved children\u0026rsquo;s development (ASQ-3 personal-social development; \u003cem\u003ed\u003c/em\u003e=.98)\u0026nbsp;(Anis, Letourneau, et al., 2020), parent-child relationship quality\u0026nbsp;(\u003cem\u003ed\u003c/em\u003e=.34-.95)\u0026nbsp;(Anis, Letourneau, et al., 2020), and parental RF (\u003cem\u003ed\u003c/em\u003e=.51-2.0)\u0026nbsp;(Letourneau, 2020).\u0026nbsp;In Phase 2, the second set of four pilot studies, ATTACH\u0026trade; significantly improved children\u0026rsquo;s development on the ASQ-3, specifically communication (\u003cem\u003ed\u003c/em\u003e=.76), personal-social (d=.44-.48), problem-solving (\u003cem\u003ed\u003c/em\u003e=.76), and fine motor skills (\u003cem\u003ed\u003c/em\u003e=.81)\u0026nbsp;(Letourneau et al., 2023; N. Letourneau et al., 2019). It also improved parental RF (\u003cem\u003ed\u003c/em\u003e=.56-.65), children\u0026rsquo;s mental health, specifically CBCL total externalizing behavioral problems (\u003cem\u003ed\u003c/em\u003e=.64), attention (\u003cem\u003ed\u003c/em\u003e=.74), aggression, (\u003cem\u003ed\u003c/em\u003e=.50), and anxiety (\u003cem\u003ed\u003c/em\u003e=.62) and parents\u0026rsquo; and children\u0026rsquo;s immune cell gene expression linked to reduced inflammation [F(1,1794)=4.26]\u0026nbsp;(Ross et al., 2021).When findings were pooled across all seven pilots, ATTACH\u0026trade; significantly improved parental RF (OR=2.3) and parent-child attachment security (OR=2.29) (Letourneau et al., 2023). Whether ATTACH\u0026trade; Online produces the same impacts, remains to be studied with a large sample. Findings from the ATTACH\u0026trade; in-person program are so compelling that the Harvard Center on the Developing Child named ATTACH\u0026trade; one of its prestigious Frontiers of Innovation projects (https://developingchild.harvard.edu/innovation-application/frontiers-of-innovation).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntegrated Knowledge Translation\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e(\u003c/strong\u003e\u003cstrong\u003eiKT) and Knowledge User Engagement.\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOur iKT\u0026nbsp;(Bowen \u0026amp; Graham, 2013; Graham et al., 2018)\u0026nbsp;and engagement activities with knowledge users, including parents, health care professionals, and administrators in agencies resulted in targeted ATTACH\u0026trade; programming and material co-development, co-adaptation, and co-evaluation. Researchers and knowledge users collaborated throughout the pilot studies in project governance, priority setting, and conduct of research. The researchers and knowledge users employed level 3 engaged participation methods characterized by collaboration and community-based participatory research methods from regular meetings and meaningful opportunities for contribution\u0026nbsp;(Goodman \u0026amp; Sanders Thompson, 2017; McCutcheon et al., 2019). Key ATTACH\u0026trade; intervention goals were developed with health care professionals and administrators in partner agencies. Knowledge users in community agencies reported preferring parenting programs that emphasize RF; however, they were often deemed unrealistic and cost-prohibitive to implement as typically involving months to years of intervention or psychotherapy\u0026nbsp;(Camoirano, 2017; Cicchetti et al., 2006; Letourneau et al., 2015). For example, one well-known RF-focused program begins prenatally and lasts for 2 or more years\u0026nbsp;(Sadler et al., 2013; Arietta Slade et al., 2005). \u0026nbsp;ATTACH\u0026trade; was thus designed to be relatively short duration (ultimately 10 weeks reduced from 12 weeks based on parents input in pilots), and feasibly administered by professionals with undergraduate education in a health-related field, typical of partner agency staff. Agency knowledge users also indicated their typical clientele present with more than one early adversity (e.g., family violence, depression, and low-income). Further, RF-focused parenting programs often do not incorporate co-parents, defined as individuals who are a main source of parenting support (i.e., biological or step father, boyfriend, grandmother/father, other relative, friend or other support person, as appropriate)\u0026nbsp;(Cowan et al., 2009; Kochanska \u0026amp; Kim, 2013). Co-parents often have an important role in buffering parents from the effects of toxic stress\u0026nbsp;(Feeney \u0026amp; Collins, 2015; Giesbrecht et al., 2013; Letourneau, Tryphonopoulos, et al., 2012). Thus, ATTACH\u0026trade; was co-designed in pilot work to: (1) help parents in complex circumstances affected by multiple stressors rather than narrowly defined stressors \u0026nbsp;(e.g. substance misuse, Suchman et al., 2008)\u0026nbsp;and (2) include a variety of co-parents, in recognition of typically observed family structures of clients seeking community services and support.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSince the completion of the pilots, additional changes to the ATTACH\u0026trade; program design derived from knowledge user engagement. To address the broad range of family structures served in partners\u0026rsquo; agencies, including both sexes/self-reported genders of parents, ATTACH\u0026trade; was adapted to the primary child caregiver (whether mother, father, grandparent, foster carer, cis-or trans-gender, etc.) and their source of co-parent support. As a result, ATTACH\u0026trade; will be more applicable across diverse family units and more realistic for implementation in community agencies. Second, ATTACH\u0026trade; materials were made more ethnically diverse by changing the manual images and employing a variety of cultures in illustrative examples of RF in families. Finally, the training of ATTACH\u0026trade; Facilitators has been made more accessible through an online \u0026lsquo;ATTACH\u0026trade; Teachable\u0026rsquo; program for training and accrediting health care professionals to deliver the program (see https://attach.teachable.com/). This resulted in trademarking the ATTACH\u0026trade; name.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCOVID-19 Challenge and Opportunity\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe COVID-19 pandemic placed unprecedented strain on families and children, the healthcare system, and researchers engaged in ongoing research with at-risk families.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn adjusting to the \u0026lsquo;new normal\u0026rsquo; of self-isolation and remote interactions from public health restrictions, the need for effective online health interventions became apparent\u0026nbsp;(Brooks et al., 2020).Parents were reluctant to see health-service providers at home or clinic due to infection fears for themselves, their child and family. Agencies also reduced in-person service delivery to parents and children. Simultaneously, ATTACH\u0026trade; knowledge users including agency staff and parents involved in the in-person ATTACH\u0026trade; delivery reported that families were desperate to obtain safe support to assist them with parenting, compounded by increasing incidence of financial strain, family violence, and mental health problems\u0026nbsp;(Forbes et al., 2021; Mueller \u0026amp; Tronick, 2019; Racine et al., 2021; Vindegaard \u0026amp; Benros, 2020; Wilson et al., 2020). Such challenges have contributed to burgeoning developmental and mental health problems in children\u0026nbsp;(Cost et al., 2021; de Miranda et al., 2020). Providing accessible, evidence-based interventions to at-risk families in the post-pandemic recovery period may prevent children\u0026rsquo;s long-term development and mental health problems. Thus, the researchers/knowledge users sought to deliver ATTACH\u0026trade; Online, rather than in-person and engaged ATTACH\u0026trade; Facilitators and parents in user-engaged design of an online intervention and data collection approach for ATTACH\u0026trade;. Users preferred Zoom\u0026trade;\u0026nbsp;(Graucher et al., 2022)\u0026nbsp;for intervention delivery and REDCap (www.project-redcap.org)\u0026nbsp;(Komanchuk et al., 2023)\u0026nbsp;for data collection and both were successfully pilot tested for feasibility with 10 families. Thus, ATTACH\u003csup\u003eTM\u003c/sup\u003e Online is poised to address social and health inequities, amplified by the pandemic, by promoting accessibility of parenting support for vulnerable families, including those in rural and remote regions. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;In summary, ATTACH\u0026trade; significantly improves children\u0026rsquo;s development, mental health, parent-child relationships including attachment security, as well as parental reflective function, and immune function. The evidence based, accessible ATTACH\u003csup\u003eTM\u003c/sup\u003e Online was co-developed with parents and agency partners, has been pilot tested, and is ready for testing effectiveness and examining implementation. Many vulnerable children and their families in Alberta stand to benefit, paving the way for widespread post-pandemic implementation to prevent and address the rising incidence of children\u0026rsquo;s development and mental health problems. Project funding in the amount of $999,013 CAD was provided by the Canadian Institutes of Health Research from 2022-2027.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy Objectives {7}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInformed by an iKT\u0026nbsp;(Graham et al., 2018)\u0026nbsp;approach (i.e. researcher/knowledge user collaboration, engagement in project governance, priority setting, and conduct of research) combined with engagement of knowledge users and parents\u0026nbsp;(Alberta SPOR SUPPORT Unit, 2018; CIHR/SPOR, 2014; Graham et al., 2018; McCutcheon et al., 2019), we propose an effectiveness implementation hybrid (EIH) Type II study of ATTACH\u0026trade; Online. The two objectives of this study are to evaluate: (1) effectiveness, and (2) implementation fidelity and uptake\u0026nbsp;(Curran et al., 2012)of ATTACH\u0026trade; Online in naturalistic, real-world settings, delivered by community partner agencies serving families affected by early adversity in Alberta.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 1:\u0026nbsp;\u003c/strong\u003eTo assess the effectiveness of ATTACH\u0026trade; Online on: (1a) the primary outcome of children\u0026rsquo;s development, and secondary outcomes of children\u0026rsquo;s mental health, parent-child relationships (including attachment quality), and parental reflective function by using validated measures before, immediately after, and 3 months after intervention, and (1b) different parent populations (for whom program works best/worst). Our primary hypothesis is ATTACH\u0026trade; Online improves children\u0026rsquo;s development in the cognitive domains of communication, personal-social, and problem solving. Secondary hypotheses examine whether ATTACH\u0026trade; Online improves children\u0026rsquo;s mental health, parent-child relationships, and parental RF.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 2:\u003c/strong\u003e To assess implementationfidelity and uptake of ATTACH\u0026trade; Online in community agencies serving at-risk families in Alberta, Canada using a validated measure and qualitative and quantitative methods during and after intervention.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial Design\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e{\u003c/strong\u003e\u003cstrong\u003e8}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis EIH Type II\u0026nbsp;(Curran et al., 2012)study is comprised of a quasi-experimental design evaluation of the community-agency delivered ATTACH\u0026trade; Online (with measurement pre-intervention, immediately post-intervention, and 3 months post-intervention) as well as an examination of implementation fidelity and uptake\u0026nbsp;(May et al., 2018; May et al., 2009).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 1: ATTACH\u0026trade; Online Effectiveness.\u0026nbsp;\u003c/strong\u003eA quasi-experimental design was selected to more closely approximates service delivery models in agencies that do not typically employ control groups. Moreover, given significant differences in randomized controlled trials and quasi-experimental pilot studies\u0026nbsp;(Anis, Letourneau, et al., 2020; Anis, Ross, et al., 2022), any design employing wait-list controls was deemed unacceptable and even unethical by the team including parents, health care professionals, and administrators from engagement activities during the preparation of this proposal. A step-wedge design\u0026nbsp;(Hemming et al., 2015)was also ruled out due to concerns with undue delays in receiving the ATTACH\u0026trade; Online program. Nonetheless, evaluation of effectiveness of the online version of the program was deemed essential by the team to ensure generalizability of findings to this new intervention modality.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 2: ATTACH\u0026trade; Online Implementation.\u003c/strong\u003e Quantification of implementation fidelity and uptake of ATTACH\u0026trade; Online will be undertaken (details below). Normalization Process Theory (NPT) will be used to explain factors that promote or inhibit implementation fidelity and uptake, and can inform strategies to support embedding implementation in practice\u0026nbsp;(May et al., 2007; May et al., 2018; May et al., 2009).Developed in response to recognition of the large gap between intervention development and intervention use in health care\u0026mdash;the \u0026lsquo;know-do gap\u0026rsquo;\u0026mdash;NPT is intended to uncover factors that interfere with the routine or \u0026ldquo;normal\u0026rdquo; incorporation of interventions into health care (Murray et al., 2010). The model explores coherence, cognitive participation, collective action, and reflexive monitoring of knowledge users with respect to the implementation of a given intervention. Thus, NPT is ideal for guiding our qualitative semi-structured interviews and analyses. Findings on the mechanisms of ATTACH\u0026trade; implementation will guide activities to promote the normalization and integration of the ATTACH\u0026trade; Online into routine community care for parents and children at-risk.\u0026nbsp;\u003c/p\u003e"},{"header":"Methods: Participants, Interventions, and Outcomes","content":"\u003cp\u003e\u003cstrong\u003eParticipants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 1:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParents, Co-Parents, and Children.\u0026nbsp;\u003c/strong\u003eFamilies including parents, their children under the age of 36 months, and their identified co-parenting support persons are our study population.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 2:\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eKnowledge Users.\u0026nbsp;\u003c/strong\u003eThese include parents, health care professionals, and administrators from community partner agencies who participate in receiving or delivering the ATTACH\u0026trade; Online program.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStakeholder Engagement:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBuilding on our pilot work, we systematically engage stakeholders in our study planning design. Stakeholders and researchers engaged in multiple meetings at formative stages. Together, we identified ATTACH\u0026trade; Online agencies for training and delivery, made changes to the ATTACH\u0026trade; Online program, designed terms of reference, and selected the outcomes of interest. Key stakeholders include\u0026nbsp;the\u0026nbsp;Principal\u0026nbsp;Knowledge User\u0026nbsp;(Reimer) and members of the Community\u0026nbsp;Engagement Committee.\u0026nbsp;Reimer is Executive Director of the Alberta Council of Women\u0026rsquo;s Shelters, the provincial network organization of women\u0026apos;s domestic violence shelters in Alberta that serves 40 members operating 50 agencies. She connected the team with \u0026nbsp;7 participating shelters whose leaders (e.g., administrators such as Executive Directors and health and social service professionals) are key community knowledge users on the Community Engagement Committee. Other Community Engagement Committee members are agency leaders operating services for teen mothers or families affected by significant adversity and trauma, as well as\u0026nbsp;parents with relevant personal experience. These team members will participate in project roll-out, may participate in interviews as participants, learn about implementation, and/or have opportunities to take part in ATTACH\u003csup\u003eTM\u003c/sup\u003e Online training and ultimately independent delivery and evaluation. GRIPP-2SF\u0026nbsp;(Preston et al., 2023; Staniszewska et al., 2017)\u0026nbsp;will be used to report on study engagement.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy Setting {9}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSettings include approximately eight Alberta agencies serving culturally diverse clients (i.e., Caucasian, Black, Indigenous, People of Colour [BIPOC], and immigrants) affected by family violence, depression, and low-income.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEligibility Criteria\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;{10}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective #1:\u003c/strong\u003e The study inclusion criteria are: (1) parents with children between birth to 32 months of age at enrollment (our age ceiling is 36 months, based on selection of age-appropriate tools for assessing children); (2) parents who agree to participate in the ATTACH\u0026trade;\u0026nbsp;Online\u0026nbsp;program consisting of 10 weeks of one-hour per week parent training sessions; (3) parents who agree to bring a co-parent for 2 of the 10 sessions; and (4) parents who are proficient in speaking and reading English.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective #2:\u003c/strong\u003e Participants (i.e., parents, co-parents, community health and social service agency administrators, and health and social service providers) must be adults (18 years of age or older), proficient in speaking and reading English, and knowledgeable or experienced in parenting programs.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntervention {11a, 11b, 11c and 11d}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo deliver the ATTACH\u0026trade; Online program, health and social service professionals (knowledge users) in collaborating agencies are required to undergo 40 hours of online and in-person training with ATTACH\u0026trade; Master Trainers (e.g., Hart), over 2-3 months. After completion of all requirements, these knowledge users are certified Facilitators, able to deliver the ATTACH\u0026trade; Online program and collect evaluation data. They will deliver the intervention independently but supported by ATTACH\u0026trade; Master Trainers. ATTACH\u0026trade; Online sessions with parents take one hour, occur weekly over 10 weeks and include three components including discussions of: (1) Digital video recordings of 3\u0026ndash;5-minute parent-child play sessions, (2) Hypothetical, mildly stressful situations (e.g., infant feeding challenges), and (3) Day-to-day real-life stressful situations of parents\u0026rsquo; choosing\u0026nbsp;(for details, see published papers: Anis et al., 2021; Anis, Letourneau, et al., 2020; Anis, Ross, et al., 2022; Letourneau et al., 2023; Letourneau, 2020).\u0026nbsp;During sessions, certified ATTACH\u0026trade; Facilitators explore the parents\u0026rsquo; perceptions of themselves and their children\u0026rsquo;s thoughts, feelings, intentions, and mental states, to maximize opportunities to practice RF. For example, a mother may be asked to consider what may be happening in her mind and the mind of her child during a shared smile in the video recorded interaction. After establishment of a therapeutic relationship with the ATTACH\u003csup\u003eTM\u003c/sup\u003e Facilitators (typically after 6 sessions), parents invite their co-parenting support person to attend 2 sessions, usually sessions 7 and 9. Social support (e.g. information about community resources, emotional and affirmational support) is also provided as needed. Our goal is to have at least 2 health care professionals at each of the eight agencies trained to deliver the ATTACH\u0026trade; Online program (for a total of 20 ATTACH\u003csup\u003eTM\u003c/sup\u003e Facilitators trained in online delivery).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOutcomes {12 including 12.1, 12.2, 12.3, 12.4, and 12.5}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA robust data collection protocol was developed during the ATTACH\u0026trade; Online pilot, revealing that measures are feasible to effectively administer online and with REDCap (www.project-redcap.org).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 1 Primary Outcome\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eChildren\u0026rsquo;s Development.\u003c/strong\u003e We will employ the parent-report ASQ-3\u0026nbsp;(Bricker \u0026amp; Squires, 2009)\u0026nbsp;to assess newborn to 36-month-old children\u0026rsquo;s development. The ASQ-3 measures cognitive (i.e. communication, personal-social skills, problem solving) and motor (i.e. gross and fine) domains of development. The ASQ-3 is suitable for 1-66-month-olds, with questions assessing children\u0026rsquo;s abilities to undertake age-appropriate tasks. Summing items in each domain provides total scores (maximum 60) with higher scores indicating more optimal outcomes. The ASQ-3 has strong internal consistency reliability (82-.88), sensitivity (.86), specificity (.85)\u0026nbsp;(Mackrides \u0026amp; Ryherd, 2011),and identifies children at risk for development problems\u0026nbsp;(Lamsal et al., 2018)\u0026nbsp;with age-appropriate cut-offs (i.e., delay) in each domain. Taking 10-15 minutes to complete, the ASQ-3 is typically administered in community agencies, thus both agencies and our pilot parents judged this measure acceptable and feasible.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 1 Secondary Outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eChildren\u0026rsquo;s Mental Health.\u003c/strong\u003e We will employ the parent-report ASQ:SE\u0026nbsp;(Squires et al., 2015)\u0026nbsp;to assess newborn to 36-month-old children\u0026rsquo;s mental health. The ASQ:SE is suitable for 1-72-month-olds, with 30 items summed to assess social-emotional development, and lower scores indicating more optimal outcomes. The ASQ:SE exhibits good internal consistency reliability (.67-.91), sensitivity (.78), specificity (.84)\u0026nbsp;(Squires et al., 2015), and provides age-appropriate cut-offs to indicate risk for mental health problems. Taking 10-15 minutes to complete, the ASQ:SE is typically administered in community agencies, thus both agencies and our pilot parents find these measures acceptable and feasible.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParent-Child Relationship Quality and Attachment\u0026nbsp;\u003c/strong\u003ewill be measured with the PCITS\u0026nbsp;(Oxford \u0026amp; Finlay, 2013)\u0026nbsp;and ATTACH\u003csup\u003eTM\u003c/sup\u003e Pre-school Attachment Screening tool (APAS) developed for this study. The PCITS\u0026nbsp;(Oxford \u0026amp; Finlay, 2013)\u0026nbsp;is an observational binary measure of relationship quality in an everyday teaching situation, designed for children 36 months or younger. Considered the gold standard for the assessment of parent-child relationship quality, PCITS consists of 73 items categorized into 6 subscales including parental sensitivity to cues, responsiveness to distress, cognitive growth fostering, and socio-emotional growth fostering, child clarity of cues and responsiveness to parent as well as parent total, child total, and parent-child total scores. Reliability and validity are well established\u0026nbsp;(Letourneau et al., 2018)and was a strong measure of intervention impact in our pilot studies\u0026nbsp;(Anis, Letourneau, et al., 2020; N. Letourneau et al., 2019).The observation typically takes 5 minutes and is video recorded to enhance the accuracy of data coding. ATTACH\u0026trade; facilitators who are health care professionals in agencies will be trained to administer the video recordings via Zoom\u0026trade;. A robust Zoom data collection protocol was developed during the ATTACH\u0026trade; Online pilot study for PCITS. Coders, reliable at 90th percentile with the University of Washington and who retained \u0026gt;95% intra-rater reliability over the course of pilot studies on 10% of recoded videos, will code all video recorded interactions. Coders are trained and supervised by PI Letourneau who has been a certified PCITS trainer since 1996 and has consistently maintained reliability in the delivery of the PCITS.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;The ATTACH\u003csup\u003eTM\u003c/sup\u003e Pre-school Attachment Screening tool (APAS), designed to be used with children between 24 months \u0026ndash; 60 months, is a tool developed to screen attachment behavior, based on coding a 5-minute free play session in which a primary caregiver (parent, guardian, or custodian) is asked to \u0026ldquo;frustrate\u0026rdquo; the child by removing the desired toy of interest from the child during a play session. Such frustration tasks are commonly used in studies that examine children\u0026rsquo;s emotion regulation [e.g.,\u0026nbsp;(e.g., Calkins et al., 2002; Calkins \u0026amp; Fox, 2002; Calkins \u0026amp; Johnson, 1998; Calkins et al., 1998; Goldsmith et al., 2008). During a 5-minute free play session, caregivers are instructed to \u0026lsquo;play with their child as they normally would\u0026rsquo; for the first three minutes of the play session, and then after receiving a cue from the camera person (usually three tapping sounds made by tapping on the camera) the caregiver is signaled to remove and disallow the child from playing with a favored toy (by holding the item behind the caregiver\u0026rsquo;s back) for one minute to induce mild frustration in the child. Then after receiving another tapping cue from the camera person (usually three tapping sounds made by tapping on the camera) the caregiver is signaled to return the desired toy of interest to the child for the last minute of play.\u003c/p\u003e\n\u003cp\u003eCoders focus on the child\u0026rsquo;s response during the frustration portion of the play session and how the caregiver may (or may not) repair the breach in the dyadic play. The child\u0026rsquo;s response to this stressful event provides valuable information about the caregiver/child relationship and the child\u0026rsquo;s attachment pattern. Trained coders observe the child\u0026rsquo;s response then classify the child\u0026rsquo;s attachment pattern as either secure (Type B) or insecure (Type A, C, D) by using similar coding indices of established attachment measures, namely the MacArthur preschool attachment coding system (MAC) as taught by Dr. William Whelan\u0026nbsp;(Anis, Ross, et al., 2022), which has been adapted for older preschool-aged children from Mary Ainsworth\u0026rsquo;s Infant Strange Situation Procedure (SSP)\u0026nbsp;(Ainsworth et al., 1978). Thus, the MAC and SSP serve as the foundational model.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParental RF.\u0026nbsp;\u003c/strong\u003eThis will be assessed via the PRFQ\u0026nbsp;(Rutherford et al., 2015)\u0026nbsp;and is an 18-item measure, with subscales assessing: (1) pre-mentalizing (2) certainty about mental states, and (3) interest and curiosity about mental states. Higher scores indicate higher levels of parental RF. The PRFQ has good internal consistency (.7-.84) and takes 5 minutes to complete. Pilot testing revealed the PRFQ detected intervention impacts and was acceptable to parents. In our other work\u0026nbsp;(Anis, Perez, et al., 2020), we show that scores on the PRFQ associate significantly (p\u0026lt;.05) with the gold standard Parental Development Interview\u0026nbsp;(Slade et al., 2004)coded with Fonagy\u0026rsquo;s 11-point scale\u0026nbsp;(Fonagy et al., 1998).Given the gold standard requires 1-2 hours per parent interview, followed by 1 hour to check automated transcriptions, and 3 hours of coding per interview (~6 hours total), the use of the PRFQ reduces parent burden, costs, and is feasible to implement in agencies.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 2 Primary Outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eImplementation Fidelity Assessment\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eATTACH Online Implementation fidelity will be assessed via a published, validated, ATTACH\u0026trade; specific fidelity tool\u0026nbsp;(Anis et al., 2021)that was developed to assess health care professionals\u0026rsquo; adherence and delivery of key ATTACH\u0026trade; intervention elements (i.e., video feedback of parent-child interactions, real life stressful and hypothetical situation reviews). ATTACH Online Implementation fidelity will be assessed more broadly by NPT interviews with parents, health care providers, and agency administrators by eliciting participants\u0026rsquo; perceptions of facilitators and barriers to achieving fidelity of delivery of ATTACH\u0026trade; Online elements and potential strategies to promote fidelity.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 2 Secondary Outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eUptake of ATTACH Online by agency clients will be quantified as a percentage score based on the number of families delivered ATTACH\u003csup\u003eTM\u003c/sup\u003e by trained service providers, divided by the number of eligible families in a given agency. NPT interviews will further determine participants\u0026rsquo; perceptions of facilitators and barriers to uptake and potential strategies to promote uptake.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParticipant Timeline {13}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 1:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePre-Intervention.\u003c/strong\u003e ATTACH\u0026trade;\u0026nbsp;Online\u0026nbsp;begins with collection of pre-intervention assessment data including observational and questionnaire sources.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eATTACH\u0026trade; Online.\u003c/strong\u003e The program begins after the pre-intervention sessions are completed\u0026ndash;usually the following week. ATTACH\u0026trade;\u0026nbsp;Online\u0026nbsp;sessions are described above in {11}:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePost-Intervention Phase.\u003c/strong\u003e The ATTACH\u0026trade;\u0026nbsp;Online\u0026nbsp;intervention must be complete before post-intervention assessment which includes parents\u0026rsquo; providing observational and questionnaire data.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDelayed Post-Intervention\u003c/strong\u003e. Three months after the post-intervention data collection is complete, parents will be reassessed, providing questionnaire data.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 2:\u003c/strong\u003e To describe implementation fidelity and uptake of the ATTACH\u0026trade; Online intervention and to explore the mechanisms influencing these outcomes with respect to coherence, cognitive participation, collective action, and reflexive monitoring, recruitment for participation in NPT interviews will begin shortly after the first family completes the ATTACH\u0026trade;\u0026nbsp;Online\u0026nbsp;program (likely in Spring, 2024). Recruitment\u0026nbsp;will continue until data saturation is attained, i.e., the degree to which new data repeats or is redundant with what was expressed in previous data\u0026nbsp;(Patton, 2002; Saunders et al., 2018).\u0026nbsp;We will employ a stopping rule. Data collection in a category (parent, health care professional, and administrator) will cease when three interviews in a row offer less than 10% new information (i.e., only one question of the 13-15 interview guide questions offers new information).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample Size {14 including 14.1}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 1:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQuantitative component.\u003c/strong\u003e We will examine pre-intervention/post-intervention differences from the primary outcome of development, and our secondary outcomes of children\u0026rsquo;s mental health, parent-child relationship and attachment quality and parental RF with 100 parents and children (aged newborn to 36 months).\u0026nbsp;We will recruit 100 families, to attain a sufficiently powered \u003cem\u003eN\u003c/em\u003e of 80 families with complete data, assuming up to 20% incomplete data. This is based on power of .90, and two-tailed\u003cem\u003e\u0026nbsp;alpha\u003c/em\u003e (\u003cem\u003ep\u003c/em\u003e\u0026lt;.05/3=.0167, given Bonferroni correction applied for separate comparisons using three developmental outcomes). Pilot data from the in-person ATTACH\u0026trade; program tests revealed relevant effect sizes for child development, ranging from \u003cem\u003ed\u003c/em\u003e=.44-.98 for communication, personal social, problem-solving skills\u0026nbsp;(Anis, Letourneau, et al., 2020; Anis, Ross, et al., 2022; Letourneau et al., 2023). Thus, eighty complete participant family data sets will be sufficient to detect conservatively moderate effect sizes for within group differences (\u003cem\u003ed\u003c/em\u003e=.44) for each of the three developmental outcomes (communication, personal-social, problem-solving) between pre-intervention and immediately post-intervention.\u0026nbsp;Multiple discussions with agency knowledge users give confidence that it will be feasible to recruit an average of 8-10 families (including parents, co-parents, and children) from each agency from rosters of parents currently seeking service and to retain them for 3 months post-intervention for follow-up. Any longer was deemed unrealistic given potential for parent relocation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 2\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eATTACH\u0026trade; Online Implementation.\u003c/strong\u003e From discussions with agency administrators, it will be feasible to recruit 20 parents, 20 health and social service providers, and 20 administrators (total n= 60) for interviews. However, recruitment and data collection will continue only until data saturation\u0026nbsp;(Anis, Letourneau, et al., 2020; Straus \u0026amp; Douglas, 2004).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecruitment {15}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 1:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eATTACH\u003c/strong\u003e\u003csup\u003eTM\u003c/sup\u003e\u003cstrong\u003eOnline Effectiveness\u003c/strong\u003e\u003cstrong\u003e.\u0026nbsp;\u003c/strong\u003eEvery partner agency will recruit 2-5 staff members for ATTACH\u0026trade;\u0026nbsp;Online\u0026nbsp;training to become the ATTACH\u0026trade; Facilitators. To\u0026nbsp;partake in ATTACH\u0026trade;\u0026nbsp;Online, participants will be identified through partner agencies.\u0026nbsp;We will recruit up to 100 parents and their newborn to 36-month-old children to retain 80 complete pre- and post-intervention data from approximately eight \u0026nbsp;Alberta agencies. Parents will be recruited from rosters of parents currently seeking services at these agencies.\u0026nbsp;ATTACH\u003csup\u003eTM\u003c/sup\u003e Online\u0026nbsp;information sheets and brochures will be posted on agency implementation sites. Agency staff will assist with recruitment as participants seek their services in routine care.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Objective 2:\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eATTACH\u003c/strong\u003e\u003cstrong\u003e\u003csup\u003eTM\u003c/sup\u003e\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;Online Implementation.\u003c/strong\u003e Parents,health and social service providers, and administrators from each of the\u0026nbsp;10\u0026nbsp;agencies will be recruited via convenience sampling methods.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: Data Collection, Data Management, Statistical Methods, Monitoring, and Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData collection methods {18a (18a.1, 18a.2) 18b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 1: ATTACH\u0026trade; Online Effectiveness.\u0026nbsp;\u003c/strong\u003eKnowledge users at agencies and researchers agreed to reduce parent burden from data collection. Thus, demographic data will be obtained from agency administrative records as much as possible, e.g., ethnicity, sex, gender, first language, marital status, education, employment, number of children, and age (parents and children) at baseline. To further reduce burden, many measures have been selected from intake data collection already conducted in agencies, e.g., ASQ-3\u0026nbsp;(Bricker \u0026amp; Squires, 2009). We will include covariate measures of adversities that are often administered at parent intake for: (1) Depressive symptoms with the Edinburgh Depression Scale (EDS)\u0026nbsp;(Cox et al., 1987; Matthey et al., 2006),a 10-item self-report tool to measure depression with sensitivity of 66.7-69% and specificity of 67.7% that takes 5 minutes to administer, (2) Family violence with the Revised Conflict Tactics Scale-Short Form (CTS2-SF)\u0026nbsp;(Straus \u0026amp; Douglas, 2004), a 20-item questionnaire with internal consistency of .79-.95 that takes 3 minutes to complete, and (3) Parents\u0026rsquo; adverse childhood experiences with the Adverse Childhood Experiences (ACE)\u0026nbsp;(Felitti \u0026amp; Anda, 2009)Questionnaire, consisting of 10 questions, with extensive reliability and validity data that takes less than 3 minutes to complete. To assess the covariate of parent strengths in the face of adversity, the Brief Resilience Scale (BRS)\u0026nbsp;(Smith et al., 2008)will also be administered, a 6-item tool with internal consistency ranging from .80-.91 that takes 3 minutes to complete. All questionnaire data will be collected at baseline, immediately post-intervention, and 3 months post-intervention by agency health care professionals/ATTACH\u0026trade; facilitators, who will be trained and supervised to collect questionnaire data via REDCap (www.project-redcap.org) using iPads provided during the ATTACH\u0026trade; training.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 2: ATTACH\u0026trade; Online Implementation.\u0026nbsp;\u003c/strong\u003eBasic demographic data will be collected from knowledge users, including age, sex, gender, employment, and education. Fidelity will be assessed via the published, validated, ATTACH\u0026trade;-specific fidelity tool\u0026nbsp;(Anis et al., 2021)completed by health care professionals after every ATTACH\u0026trade; interaction with parents. Uptake-relevant data will be collected from agency administrators via a brief survey including their demographic information. NPT interviews will further examine implementation fidelity and uptake and mechanisms to promote more optimal delivery of ATTACH\u0026trade; Online. These will begin shortly after the initially enrolled parents complete the intervention and continue until data saturation. An NPT-guided interview was created to assess implementation and finalized with input from knowledge users engaged in review, feedback and decision making and pilot tested before use. Interviews will be digitally audio recorded with Zoom\u0026nbsp;(Graucher et al., 2022)\u0026nbsp;and automatically transcribed verbatim with Otter.ai\u0026nbsp;(Lee et al., 2022; Mahdi, 2021),and checked for accuracy, with privacy protections in place to guard participant identity and personal information.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Management {19}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePartner agencies will collect the data via iPads with REDCap software installed, as per best practice recommendations\u0026nbsp;(Garcia \u0026amp; Abrah\u0026atilde;o, 2021; Komanchuk et al., 2023; Rivera et al., 2021).Agency health and social service providers/ATTACH\u0026trade;\u0026nbsp;Online\u0026nbsp;Facilitators\u0026nbsp;will be trained and supervised to employ the iPads and REDCap as part of the ATTACH\u0026trade;\u0026nbsp;Online\u0026nbsp;Training Program. Partner\u0026nbsp;agency health and social service providers/ATTACH\u003csup\u003eTM\u003c/sup\u003eOnline facilitators will be provided with a login information to access the baseline, immediate post-intervention, and delayed post-intervention questionnaires. After logging in, Facilitators will ask the participant to fill out the questionnaires, which will only request de-identified data (except for required linkage to consent, filed separately); data will be automatically shared to the REDCapwebsite after completion. Any data sharing or communication from the partner agencies will be done via the University of Calgary domain specific email account. Digital video data will be saved on the iPads and uploaded to secure Box on the cloud (https://www.box.com/en-ca/capture). The staff at the local agencies will be trained to delete any digital data from the iPads. Digital copies of transcripts and audio files will be kept in a secure network location administered by the University of Calgary\u0026rsquo;s Information Technology services and accessible only to the research team.\u003c/p\u003e\n\u003cp\u003eAll the information contained in our analyses and summaries will be anonymous and based on group data. Published reports will not identify participants by name, address, agency, or any other personal information. Furthermore, all research team members are aware of the importance of maintaining participant anonymity and are required to sign a confidentiality agreement.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical Methods {20a (20a.1), 20b and 20c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe will analyze the demographic characteristics of the sample with measures of central tendency and frequencies as\u0026nbsp;appropriate. Alpha will be set \u003cem\u003ea priori\u003c/em\u003e at .05 (two-tailed) unless testing directional hypothesis (one-tailed).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 1: ATTACH\u003c/strong\u003e\u003csup\u003eTM\u003c/sup\u003e\u003cstrong\u003eOnline\u003c/strong\u003e \u003cstrong\u003eEffectiveness\u003c/strong\u003e\u003cstrong\u003e.\u0026nbsp;\u003c/strong\u003eFor(1a), to evaluate ATTACH\u003csup\u003eTM\u003c/sup\u003e Online program effects\u0026nbsp;on\u0026nbsp;children\u0026rsquo;s development (primary outcome), children\u0026rsquo;s mental health, parent-child relationship and attachment quality, and parental RF (secondary outcomes) immediately post-intervention and at 3 months post-intervention,\u0026nbsp;we will employ repeated measures analysis of variance (ANOVA), paired-t-tests, and chi-square tests to examine outcomes between baseline, immediate post-intervention, and delayed post-intervention assessments. We will undertake three sets of analyses for our primary hypotheses tests. For (1b) to determine whether ATTACH\u003csup\u003eTM\u003c/sup\u003e Online\u0026nbsp;is equally effective across parent populations (and for whom it works best/worst), we will examine differences among sub-groups derived from known covariates through use of independent samples \u003cem\u003et\u003c/em\u003e-tests (two groups, e.g., child sex), ANOVAs (more than 2 groups, e.g., race/ethnicity), repeated measures analysis of covariance (with identified covariate) and linear regression models (continuous covariate, e.g., age, years of education).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAdditionally, we will consider child sex as a covariate and stratification variable in our analyses. We will include both mothers and fathers in the ATTACH\u003csup\u003eTM\u003c/sup\u003e Online implementation and examine impacts on parents as a group, with separate analyses for mothers and fathers, even though fathers are likely to be far fewer in number than mothers. (One of our partner agencies serves many fathers). We will also consider gender in our analyses. Parents will report the gender that they identify with, preferred pronoun, and preferred term for themselves as a parent, e.g. mother, father, or another word. While insufficient numbers will likely limit interpretability, we will consider parents\u0026rsquo; characterizations as cis-, trans-gender, or gender-diverse in analyses. For children, while it is unlikely that preschoolers will be non cis-gender, we will consider parent-reported child gender in our analyses, to the degree possible. These analyses will help determine how the ATTACH\u003csup\u003eTM\u003c/sup\u003e Online may affect different sex and gender-based patient populations.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective 2:\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eATTACH\u003c/strong\u003e\u003csup\u003eTM\u003c/sup\u003e\u003cstrong\u003e\u0026nbsp;Online\u003c/strong\u003e\u003cstrong\u003eImplementation\u003c/strong\u003e\u003cstrong\u003e.\u0026nbsp;\u003c/strong\u003eThe fidelity assessment tool will be quantified by evaluating adherence to program content elements; each element is coded as Yes (attempted= implemented as intended) or No (not attempted = never asked or failed to perform)\u0026nbsp;(Anis et al., 2021). To be considered satisfactory, content fidelity is expected to be 90% or higher for Yes category, or 10\u0026ndash;20% or lower for No category\u0026nbsp;(Anis et al., 2021). After all participants have been recruited, uptake data will be calculated with scores applied to each agency. Data on variables such as health care professionals\u0026rsquo; years of experience, age, gender will be collected and considered for their impacts on fidelity and uptake. Qualitative analysis of NPT interviews will involve the stages of thematic analysis including familiarization, coding, theme development, and data reporting\u0026nbsp;(Terry et al., 2017). Theme and sub-theme development will be deductive, using \u003cem\u003ea priori\u003c/em\u003e codes dictated by interview questions to explain factors that promote or inhibit the intervention from being embedded in agency practice. Two trainees will code the data, supervised by PI\u0026nbsp;Letourneau, who is experienced in qualitative data analysis. Coding will inform when data saturation is reached. Data will be managed with\u0026nbsp;Dedoose\u0026nbsp;(Sociocultural Research Consultants, 2021). Data from parents, service providers, and administrators will be coded separately, and coding trees examined for similarities and differences\u003cem\u003e\u0026nbsp;post-hoc\u003c/em\u003e. Once themes and sub-themes are finalized, findings summarized in draft reports will be shared with key informants as a validation check\u0026nbsp;(Richards, 2005). Data from parents, service providers, and administrators will be coded separately, and coding trees examined for similarities and differences\u003cem\u003e\u0026nbsp;post-hoc\u003c/em\u003e.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: Monitoring\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Monitoring {21a, 21b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBecause this is a social intervention, not a drug or pharmaceutical trial, there is no data monitoring committee or interim analysis\u0026nbsp;(Anis, Letourneau, et al., 2022).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHarms {22}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eObserved incidents such as mental health crises, will be documented and managed as necessary by agency personnel delivering ATTACH\u0026trade; Online (e.g., by providing appropriate comfort measures as well as mental health referrals). It is important to note that ATTACH\u0026trade; facilitators are also employees of health and social service agencies who serve the clients/participants. If the investigators or ATTACH\u0026trade; facilitators interacting with these families observe child abuse, they will report it to the Law Enforcement Authorities, as is required by law.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuditing {23}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAs ATTACH\u003csup\u003eTM\u003c/sup\u003e is a social intervention rather than a drug or pharmaceutical trial, there is no data auditing\u0026nbsp;(Anis, Letourneau, et al., 2022).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics and Dissemination\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResearch Ethics\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eApp\u003c/strong\u003e\u003cstrong\u003eroval and Consent or Assent {24 and 26a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthics\u0026nbsp;approval has been obtained from the Conjoint Health Research Ethics Board (CHREB; Ethics ID: REB20-0903) of the University of Calgary, and all participants will undergo a process seeking their informed consent. The University of Calgary is the lead agency conducting this study and partner agency research sites rely on CHREB\u0026rsquo;s\u0026nbsp;approval as part of their agency ethics protocols. All funding and research guidance flows from the University of Calgary and while partner agencies will typically not have access to the study data, nor have direct involvement in data analysis or data storage, some knowledge users involved in the project may become more involved, requiring their addition to the ethics file as needed with all appropriate safeguards for participant safety, anonymity, and confidentiality maintained.\u0026nbsp;All participants will be asked to provide informed consent. The process of informed consent involves verbal consent secured at each stage of the process, including recruitment, screening, intervention, and data collection. Participants will be provided with an electronic consent form for their signature. This will be retained by the study investigators and participants will receive a signed copy.\u0026nbsp;We have created different consent forms for the and intervention participation and individual interviews to clearly indicate\u0026nbsp;to\u0026nbsp;what participants are consenting (see\u0026nbsp;Appendix 1; Appendix 2).\u003c/p\u003e\n\u003cp\u003eThe voluntary nature of the study will be reinforced verbally throughout the consent process and, indeed, throughout the course of the participants\u0026rsquo; involvement in the study data collection. They may choose not to answer some questions, or to withdraw from the study at any time without affecting their receipt of the ATTACH\u0026trade; Online program, health care or other partner agencies\u0026rsquo; services. If they choose to no longer participate (at any time including once data analysis has begun), we will retain their data for attrition analyses, unless asked explicitly to remove data from the study, in which case we will attain the participants\u0026rsquo; unique numeric identification (see below, Confidentiality) and delete all relevant data. Staff at the participating agencies will avoid any coercion by letting the potentially interested families know that their participation is completely voluntary, and that they can withdraw any time. Access to agency services will not be affected by participation or withdrawal.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eEthics approval has been received for an adaptive honorarium schedule of gift cards that provides increased compensation commensurate with increased parent burden. This schedule emerged from numerous collaborative conversations with parents and agency health and social service administrators and providers. Study participants will be offered $100.00 in Amazon gift cards in increasing value over 10 sessions. Moreover, each NPT interviewee will be given a $30 gift card, in compensation for a 60\u0026ndash;90-minute NPT interview.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eProtocol amendments {25}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThere have been no amendments to the protocol.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent or assent {26b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn ancillary studies, participants\u0026apos; data and biological specimens are not subject to additional consent provisions.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConfidentiality {27}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll data will be held confidentially and stored on a secure network drive. To ensure anonymity, participants will be assigned unique numeric codes in place of names. There will be no use of personal email accounts or emails for communication or for sharing of data. To ensure that participants understand the privacy and confidentiality nature of the study, the staff will ensure that they sign the consent form at the beginning of the study. Additional steps may include reiterating the privacy and confidentiality nature of the study before initiating the video recording.\u003c/p\u003e\n\u003cp\u003eThe partner agencies will collect demographic information about parents, such as their name and age. Apart from the consent form (stored separately), partner agencies will only share de-identified data associated with participants\u0026rsquo; unique numeric codes, with the ATTACH\u003csup\u003eTM\u003c/sup\u003e Online Team. The demographic information will be used to describe our sample in our future publications. The interactions between the parents and children will be video recorded for the purpose of assessing the quality of parent-child interaction and attachment. These assessments are based on age and any video data that is digital will be password protected and encrypted. Participants will only be identified by an ID number, so researchers will not have access to any identifying information. Any identifying information will be removed from the beginning and replaced with an ID number for analysis. Only the research team will have access to questionnaire response data. All information provided by participants will be kept confidential, except when it needs to be reported as required by law (such as when participants express a desire to do harm to themselves or others). Participants will not be identified in any publications or presentations that result from this research. The findings will be presented at health conferences and published in scientific journals as aggregate data. Any information that could identify participants will not be included.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDeclaration of interests {28}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo competing interests are declared by the authors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAccess to data {29}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData used and/or analyzed during this study may be made available by the corresponding author upon request and in compliance with the University of Calgary and ATTACH\u003csup\u003eTM\u003c/sup\u003e Online program research collaboration and data transfer guidelines.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDissemination policy\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;{31a, 31b, 31c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eOur team including researchers and the Community Engagement Committee members, will generate an array of dissemination products, including traditional high-impact peer-reviewed papers and presentations as well as innovative products such as in-services, infographics, and opinion-editorials. Principal knowledge user Reimer will share progress/findings in the network of Women\u0026rsquo;s Shelters in Alberta, promoting widespread ATTACH\u003csup\u003eTM\u003c/sup\u003e Online program uptake. We will continue our ongoing ATTACH\u0026trade; webinar series (see https://attach.teachable.com/ p/webinar-series), sharing progress and emerging findings with a wide audience. Publications will adhere to CIHR\u0026rsquo;s open access policy (http://www.cihr-irsc.gc.ca/e/46068.html) as well as CIHR\u0026rsquo;s sex and gender-based analysis policy (http://www.cihr-irsc.gc.ca/e/ 50833.html). Reporting guidelines will be employed in published papers, e.g., Consolidated Standards of Reporting Trials (CONSORT) (Antes, 2010; Schulz et al., 2010), Template for Intervention Description and Replication (TIDieR) checklist (Hoffmann et al., 2014), GRIPP-2SF (Preston et al., 2023; Staniszewska et al., 2017), and Consolidated Criteria for Reporting Qualitative (COREQ) (Tong et al., 2007) research.\u0026nbsp;\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eHarvard University\u0026rsquo;s Center on the Developing Child suggests that achieving\u003c/p\u003e \u003cp\u003eimproved development and mental health of children exposed to early adversity (e.g. family violence) requires effective early interventions focused on supporting parent-child relationships (Center on the Developing Child, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e2016\u003c/span\u003e; Center on the Developing Child at Harvard University, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e2010\u003c/span\u003e, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e2016\u003c/span\u003e). Interventions that focus on promoting parental RF in the context of parent-child relationships have perhaps the greatest potential to improve development and mental health for these at-risk children (Letourneau et al., \u003cspan citationid=\"CR78\" class=\"CitationRef\"\u003e2015\u003c/span\u003e; Ordway et al., \u003cspan citationid=\"CR100\" class=\"CitationRef\"\u003e2015\u003c/span\u003e). Should the findings reveal effectiveness and mechanisms for ATTACH\u0026trade; that facilitate implementation fidelity and uptake, efforts will be undertaken to spread and scale ATTACH\u0026trade; Online across Alberta, and ultimately Canada and globally, addressing societal health inequities that begin in early childhood from exposure to adversities. We have thoroughly pilot tested all approaches and the current study will evaluate of the effectiveness of ATTACH\u0026trade; Online with a larger sample. Our naturalistic design and deliverables are feasible, based on past and planned engagement and extensive pilot work, and partnership with agencies delivering the program in the context of their services for families affected by adversities. Findings on the mechanisms of ATTACH\u0026trade; implementation will guide activities to promote the normalization and integration of the ATTACH\u0026trade; Online into routine community care for parents and children at-risk of developmental and mental health problems. Successful implementation of ATTACH\u0026trade;, delivered online, has the potential to promote health equity of families affected by toxic stress and could serve as a population health strategy (Organization, \u003cspan citationid=\"CR101\" class=\"CitationRef\"\u003e2022\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eStatus of Trial:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRecruitment in progress; start date of recruitment: Fourth-quarter, 2022\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics Approval and Consent to Participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthics approval has been obtained from the Conjoint Health Research Ethics Board (CHREB; Ethics ID: REB20-0903) of the University of Calgary, and all participants will undergo a process of informed consent. The University of Calgary is the lead agency conducting the study and partner agency research sites rely on CHREB\u0026rsquo;s approval as part of their agency ethics protocols. All funding and research guidance flows from the University of Calgary and partner agencies will not have access to the study data, nor will they be involved in data analysis or data storage. The participants will be asked to provide informed consent. We have created different consent forms for the individual interviews and intervention participation to clearly indicate to parents what they are consenting to participate in (see Appendix 1 and 2).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent to Publish\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of Data and Materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and/or analyzed during this study can be made available by the corresponding author upon request and in accordance with the research collaboration and data transfer guidelines of the University of Calgary and the ATTACH\u003csup\u003eTM\u003c/sup\u003e Online researchers. Materials\u0026nbsp;including all relevant raw data, will be freely available to any scientist wishing to use them for non-commercial purposes, without breaching\u0026nbsp;participant confidentiality.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors MH and NL are co-owners of the for-profit and not-for-profit companies engaged in delivering ATTACH\u0026trade;. All other authors have no competing interests to report.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdherence to national and international regulations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eConceptualization: NL, LA, CC, IDG, KR, KN, JR, MP, EW, SL, SV, MJS, AS, AS, BT, LH, TB, and MH.Literature review: NL, LA, CC, IDG, KR, KN, JR, MP, EW, SL, SV, MJS, AS, AS, BT, LH, TB, and MH. Study Protocol Development: NL, LA, CC, IDG, KR, KN, JR, MP, EW, SL, SV, MJS, AS, AS, BT, LH, TB, and MH.Validation: NL, LA, CC, IDG, KR, KN, JR, MP, EW, SL, SV, MJS, AS, AS, BT, LH, TB, and MH. Writing\u0026mdash;original draft preparation: NL, LA, CC, IDG, KR, KN, JR, MP, EW, SL, SV, MJS, AS, AS, BT, LH, TB, and MH. Writing\u0026mdash;review and editing: NL, LA, CC, IDG, KR, KN, JR, MP, EW, SL, SV, MJS, AS, AS, BT, LH, TB, and MH. Resources: NL, LA, CC, IDG, KR, KN, JR, MP, EW, SL, SV, MJS, AS, AS, BT, LH, TB, and MH. Funding acquisition: NL, LA, CC, IDG, KR, KN, JR, MP, EW, SL, SV, MJS, AS, AS, BT, LH, TB, and MH. All of the co-authors have read and approved the final manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eAbdollahi F, Abhari FR, Zarghami M. (2017). Post-partum depression effect on child health and development. 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J Occup Environ Med. 2020;62(9):686\u0026ndash;91.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-pediatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bped","sideBox":"Learn more about [BMC Pediatrics](http://bmcpediatr.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bped/default.aspx","title":"BMC Pediatrics","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Study protocol, ATTACH™, Online program, Effectiveness-implementation hybrid (EIH) Type II study, Quasi-experimental design, Parenting program, Reflective function, Parent-child interaction, Child development, Normalization process theory","lastPublishedDoi":"10.21203/rs.3.rs-4487245/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4487245/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eExposure to early childhood adversities, such as family violence, parental depression, or low-income, undermine parent-child relationship quality and attachment leading to developmental and mental health problems in children. Addressing impacts of early childhood adversity can promote children’s development, giving them the best start in life. Parental reflective function (RF), or parents' ability to understand their own and children's mental states, can strengthen parent-child relationships and attachment and buffer the negative effects of early adversity. We developed and tested ATTACH™ (Attachment and Child Health), an effective RF intervention program for parents and their preschool-aged children at-risk from early adversity. Pilot studies revealed significantly positive impacts of ATTACH™ from in-person (\u003cem\u003en =\u003c/em\u003e 90 dyads) and online (\u003cem\u003en\u003c/em\u003e = 10 dyads) implementation. The two objectives of this study are to evaluate: (1) effectiveness, and (2) implementation fidelity and uptake of ATTACH™ Online in community agencies serving at-risk families in Alberta, Canada. Our primary hypothesis is ATTACH™ Online improves children’s development. Secondary hypotheses examine whether ATTACH™ Online improves children’s mental health, parent-child relationships, and parental RF.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe will conduct an effectiveness-implementation hybrid (EIH) type 2 study. Effectiveness will be examined with a quasi-experimental design while implementation will be examined via descriptive quantitative and qualitative methods informed by Normalization Process Theory (NPT). Effectiveness outcomes examine children’s development and mental health, parent-child relationships, and RF, measured before, after, and 3 months post-intervention. Implementation outcomes include fidelity and uptake of ATTACH™ Online, assessed via tailored tools and qualitative interviews using NPT, with parents, health care professionals, and administrators from agencies. Power analysis revealed recruitment of 100 families with newborn to 36-month-old children are sufficient to test the primary hypothesis on 80 complete data sets. Data saturation will be employed to determine final sample size for the qualitative component, with an anticipated maximum of 20 interviews per group (parents, heath care professionals, administrators).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study will: (1) determine effectiveness of ATTACH™ Online and 2) understand mechanisms that promote implementation fidelity and uptake of ATTACH™ Online. Findings will be useful for planning spread and scale of an effective program poised to reduce health and social inequities affecting vulnerable families.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eName of registry: https://clinicaltrials.gov/.\u003c/p\u003e\n\u003cp\u003eRegistration number: NCT05994027\u003c/p\u003e","manuscriptTitle":"Study Protocol for Assessing the Effectiveness, Implementation Fidelity and Uptake of Attachment \u0026amp; Child Health (ATTACHTM) Online: Helping Children Vulnerable to Early Adversity","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-08-07 17:49:00","doi":"10.21203/rs.3.rs-4487245/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-08-20T06:52:52+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-08-20T06:50:46+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"116658000142996805332745672639621273858","date":"2024-08-20T06:48:14+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-08-16T08:52:05+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-07-15T06:50:59+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-07-15T06:49:41+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Pediatrics","date":"2024-05-27T23:46:44+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-pediatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bped","sideBox":"Learn more about [BMC Pediatrics](http://bmcpediatr.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bped/default.aspx","title":"BMC Pediatrics","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"4f0ca21f-4aa3-49de-a71a-f8a51e97823d","owner":[],"postedDate":"August 7th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-04-14T16:10:16+00:00","versionOfRecord":{"articleIdentity":"rs-4487245","link":"https://doi.org/10.1186/s12887-024-05232-w","journal":{"identity":"bmc-pediatrics","isVorOnly":false,"title":"BMC Pediatrics"},"publishedOn":"2025-04-09 16:05:38","publishedOnDateReadable":"April 9th, 2025"},"versionCreatedAt":"2024-08-07 17:49:00","video":"","vorDoi":"10.1186/s12887-024-05232-w","vorDoiUrl":"https://doi.org/10.1186/s12887-024-05232-w","workflowStages":[]},"version":"v1","identity":"rs-4487245","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4487245","identity":"rs-4487245","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}