Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT07170605
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2025-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Building Resilience Program: Examining Self-Regulation, Behavior, and Resilience in Under-Resourced Preschoolers With ACEs
Sponsor:
Cleveland State University
Organization:
Study Overview
Official Title:
Implementing a Resilience Program in a Trauma-Informed Preschool Population
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
\# Brief Summary
The goal of this clinical trial is to learn if a occupational therapy-led trauma-informed care intervention can improve resilience, self-regulation, coping skills, and emotional health in preschoolers ages 2-4 years from under-resourced neighborhoods with a history of adverse childhood experiences (ACEs) and their caregivers. The main questions it aims to answer are:
* Does the Building Resilience Program (BRP) improve stress management, self-regulation, positive affect, engagement, self-efficacy, coping skills and resilience in preschool children?
* Does the Building Resilience Program (BRP) improve resilience, emotional management, and coping strategies in caregivers?
Researchers will compare the Building Resilience Program group to a school readiness skills comparison group to see if the trauma-informed intervention produces greater improvements in resilience and related outcomes.
Participants will:
* Complete pre- and post-intervention assessments measuring resilience, coping skills, emotional health, occupational engagement, and quality of life
* Attend 40-60 minute group sessions, 3x a week for 8 weeks (children will participate in either the BRP intervention or school readiness comparison group)
* Complete individualized Goal Attainment Scaling to track personal progress (children)
* Attend 2-3 in-person caregiver group sessions during the 8-week intervention period plus pre- and post-intervention meetings (caregivers)
* Complete a program evaluation questionnaire at the end of the study (caregivers)
The goal of this clinical trial is to learn if a occupational therapy-led trauma-informed care intervention can improve resilience, self-regulation, coping skills, and emotional health in preschoolers ages 2-4 years from under-resourced neighborhoods with a history of adverse childhood experiences (ACEs) and their caregivers. The main questions it aims to answer are:
* Does the Building Resilience Program (BRP) improve stress management, self-regulation, positive affect, engagement, self-efficacy, coping skills and resilience in preschool children?
* Does the Building Resilience Program (BRP) improve resilience, emotional management, and coping strategies in caregivers?
Researchers will compare the Building Resilience Program group to a school readiness skills comparison group to see if the trauma-informed intervention produces greater improvements in resilience and related outcomes.
Participants will:
* Complete pre- and post-intervention assessments measuring resilience, coping skills, emotional health, occupational engagement, and quality of life
* Attend 40-60 minute group sessions, 3x a week for 8 weeks (children will participate in either the BRP intervention or school readiness comparison group)
* Complete individualized Goal Attainment Scaling to track personal progress (children)
* Attend 2-3 in-person caregiver group sessions during the 8-week intervention period plus pre- and post-intervention meetings (caregivers)
* Complete a program evaluation questionnaire at the end of the study (caregivers)
Detailed Description:
Background and Rationale Children living in under-resourced, poverty-stricken neighborhoods face significantly higher risks for adverse childhood experiences (ACEs) and trauma. In the East Cleveland, Ohio neighborhoods where this study will be conducted, poverty affects 36.5%- 41.6% of residents respectively, compared to the national average of 11.9%. Among neighborhood children, 52.8% to 54.9% live in poverty, with upwards of 80% being Black minorities. More than half of residents qualify for foodbank benefits and less than half have secure, affordable housing.
ACEs related to poverty and low socioeconomic status include experiencing abuse, neglect, witnessing violence or mental illness, food or housing instability, and incarceration of a parent or caregiver. These experiences can severely impact overall quality of life, mental health, and often lead to developmental delays and long-term effects. When parents themselves were impacted by ACEs, it can lead to intergenerational transmission of negative effects.
The American Academy of Pediatrics has specifically identified the critical need to provide interventions that build resilience and address maladaptive responses due to toxic stress resulting from ACEs. Occupational therapists are particularly well-suited to integrate trauma-informed care (TIC) into service delivery through direct intervention and by embedding strategies within occupational engagement, particularly through play as the primary occupation for young children.
Study Design and Innovation This pilot study builds on a prior feasibility study conducted at the YWCA (Young Women's Christian Association) of Cleveland between April-June 2022. The Building Resilience Program (BRP) manual was originally developed for school-age children with chronic pain and was modified to be age and content appropriate for preschoolers ages 2-4 years with trauma history.
The study employs a randomized two-group pre-posttest comparison waitlist design. Given the maximum enrollment of approximately 40 participants at the YWCA Early Learning Center, the study cannot account for all factors that could introduce bias, but the use of a comparison, non-BRP condition will allow comparison between groups over time and account for potential maturation effects. The comparison group will participate in a basic school readiness skills group that excludes resilience training components to avoid contaminating the intervention protocol while providing similar positive adult interactions that could introduce bias.
Intervention Protocols Included both the Building Resilience Program (BRP) primary intervention and the School Readiness Comparison Protocol. In parallel with participants in the BRP condition, caregivers also participate in 2-3 weekly modules in a separate, caregiver group.
Caregiver Component Based on feasibility study findings showing challenges with weekly caregiver participation, the caregiver requirement has been reduced to 2-3 in-person sessions over 8 weeks, combined with incentives and supports to encourage participation. The BRP manual includes weekly parent activities corresponding with child activities.
Caregiver sessions will be conducted by occupational therapists and occupational therapy students, combining materials for in-person sessions as follows:
1. Pre-intervention meeting: BRP and study description, introduction to resilience, highlights from Inside Out movie, Zones of Regulation overview, Q\&A
2. Week 3 session: family resilience, high vs. low resilience, resiliency BINGO activity, Kawa River model, Q\&A
3. Week 6 session: adaptive vs. maladaptive behaviors, coping strategies, mindfulness, sensory processing and "sensory solutions," community resources
4. Post-intervention meeting: child and self-advocacy, joint plant activity, program review
Recruitment Strategies
Recruitment lessons learned from the feasibility study have informed enhanced strategies:
1. Extended recruitment period from October-December 2023
2. Multiple meeting options: 18 total meetings (3 evening, lunch, and weekend options offered both in-person and virtually)
3. Comprehensive incentive structure: meals and refreshments at in-person meetings, travel compensation (bus passes), optional childcare, small gift card incentives for families completing consent forms and pre-test packets regardless of meeting attendance
4. Multiple distribution methods: paper packets sent home for families unable to attend meetings, with research team available via telephone or email for questions Previously, for the feasibility study participants were recruited by YWCA staff using classroom apps and paper packets, with caregiver pretest documents completed only when gift card incentives were offered. No caregivers participated in weekly Zoom sessions when no incentives were provided.
Statistical Analysis Plan Child Participants (Aim 1)
Each measure will be treated as a continuous variable with six measurement points (excluding Goal Attainment Scaling documented weekly and analyzed over all 8 weeks of BRP participation). Three primary analyses will be conducted:
1. Intervention Effect for Group A: Repeated Measures MANOVA (multivariate analysis of variance) comparing multiple dependent/outcome variables before and after BRP intervention
2. Intervention Effect for Group B: Repeated Measures MANOVA comparing multiple dependent/outcome variables before and after BRP intervention
3. Combined Intervention Effect: Repeated Measures MANCOVA assessing differences between Groups A and B across all measures following BRP intervention, controlling for school readiness program effects for Group B Goal Attainment Scaling T-scores will be calculated according to best practice protocols, with charts created to visualize changes over time, providing individualized, client-centered program measurement for intervention.
Caregiver Participants (Aim 2) Pre-posttest comparisons will be made using MANCOVA approach for multiple dependent variables, with baseline Social Support Survey Instrument scores included as a covariate to control for social support effects on caregivers' emotion management abilities and adaptive coping skills demonstration.
Implementation Considerations
Anticipated Challenges and Mitigation Strategies
1. Irregular attendance: Intervention provided twice weekly to increase exposure opportunities
2. Recruitment and form completion: Additional incentives available if needed, with flexible meeting scheduling options
3. Unidentified diagnoses in preschool participants: Goal Attainment Scaling will address different performance skills and individualize program goals and activities
4. Language barriers: Adapted materials may be needed for caregivers not speaking English as first language, with YWCA community partner guidance for resolution strategies
Community Partnership The YWCA Early Learning Center serves as the on-site location, providing services to under-resourced families, almost all of whom have experienced homelessness and trauma. The YWCA does not currently provide occupational therapy services, making this collaboration an innovative approach to expanding trauma-informed care access in the community.
This study addresses major obstacles in engaging caregivers from under-resourced families who experience chronic stress due to underemployment, financial instability, unstable housing, unpredictable work schedules, and lack of financial resources including childcare. These caregivers cannot afford to volunteer time and efforts without appropriate supports and incentives.
Theoretical Framework The study is rooted in occupational therapy theory, resilience theory and science, with activities derived from existing literature. The program recognizes play as the primary occupation for preschoolers, introducing resiliency concepts through occupation-based intervention approaches. The trauma-informed care framework guides all intervention delivery, acknowledging the impact of trauma on development and the need for safe, supportive environments that promote healing and growth.
Expected Outcomes and Clinical Implications This pilot study will provide necessary data to understand effects of TIC-based intervention programs implemented by occupational therapists on social, emotional, mental health, coping abilities and life satisfaction in this vulnerable population. Results will inform parameters surrounding program implementation, including successes and challenges encountered, which are important for future effectiveness studies and translation into widespread clinical and community practice.
The study aligns with current funding agency priorities for mental health, resilience and trauma-informed care in pediatric populations, providing pilot data necessary for larger-scale funding applications that would support program implementation across multiple preschools and neighborhoods.
ACEs related to poverty and low socioeconomic status include experiencing abuse, neglect, witnessing violence or mental illness, food or housing instability, and incarceration of a parent or caregiver. These experiences can severely impact overall quality of life, mental health, and often lead to developmental delays and long-term effects. When parents themselves were impacted by ACEs, it can lead to intergenerational transmission of negative effects.
The American Academy of Pediatrics has specifically identified the critical need to provide interventions that build resilience and address maladaptive responses due to toxic stress resulting from ACEs. Occupational therapists are particularly well-suited to integrate trauma-informed care (TIC) into service delivery through direct intervention and by embedding strategies within occupational engagement, particularly through play as the primary occupation for young children.
Study Design and Innovation This pilot study builds on a prior feasibility study conducted at the YWCA (Young Women's Christian Association) of Cleveland between April-June 2022. The Building Resilience Program (BRP) manual was originally developed for school-age children with chronic pain and was modified to be age and content appropriate for preschoolers ages 2-4 years with trauma history.
The study employs a randomized two-group pre-posttest comparison waitlist design. Given the maximum enrollment of approximately 40 participants at the YWCA Early Learning Center, the study cannot account for all factors that could introduce bias, but the use of a comparison, non-BRP condition will allow comparison between groups over time and account for potential maturation effects. The comparison group will participate in a basic school readiness skills group that excludes resilience training components to avoid contaminating the intervention protocol while providing similar positive adult interactions that could introduce bias.
Intervention Protocols Included both the Building Resilience Program (BRP) primary intervention and the School Readiness Comparison Protocol. In parallel with participants in the BRP condition, caregivers also participate in 2-3 weekly modules in a separate, caregiver group.
Caregiver Component Based on feasibility study findings showing challenges with weekly caregiver participation, the caregiver requirement has been reduced to 2-3 in-person sessions over 8 weeks, combined with incentives and supports to encourage participation. The BRP manual includes weekly parent activities corresponding with child activities.
Caregiver sessions will be conducted by occupational therapists and occupational therapy students, combining materials for in-person sessions as follows:
1. Pre-intervention meeting: BRP and study description, introduction to resilience, highlights from Inside Out movie, Zones of Regulation overview, Q\&A
2. Week 3 session: family resilience, high vs. low resilience, resiliency BINGO activity, Kawa River model, Q\&A
3. Week 6 session: adaptive vs. maladaptive behaviors, coping strategies, mindfulness, sensory processing and "sensory solutions," community resources
4. Post-intervention meeting: child and self-advocacy, joint plant activity, program review
Recruitment Strategies
Recruitment lessons learned from the feasibility study have informed enhanced strategies:
1. Extended recruitment period from October-December 2023
2. Multiple meeting options: 18 total meetings (3 evening, lunch, and weekend options offered both in-person and virtually)
3. Comprehensive incentive structure: meals and refreshments at in-person meetings, travel compensation (bus passes), optional childcare, small gift card incentives for families completing consent forms and pre-test packets regardless of meeting attendance
4. Multiple distribution methods: paper packets sent home for families unable to attend meetings, with research team available via telephone or email for questions Previously, for the feasibility study participants were recruited by YWCA staff using classroom apps and paper packets, with caregiver pretest documents completed only when gift card incentives were offered. No caregivers participated in weekly Zoom sessions when no incentives were provided.
Statistical Analysis Plan Child Participants (Aim 1)
Each measure will be treated as a continuous variable with six measurement points (excluding Goal Attainment Scaling documented weekly and analyzed over all 8 weeks of BRP participation). Three primary analyses will be conducted:
1. Intervention Effect for Group A: Repeated Measures MANOVA (multivariate analysis of variance) comparing multiple dependent/outcome variables before and after BRP intervention
2. Intervention Effect for Group B: Repeated Measures MANOVA comparing multiple dependent/outcome variables before and after BRP intervention
3. Combined Intervention Effect: Repeated Measures MANCOVA assessing differences between Groups A and B across all measures following BRP intervention, controlling for school readiness program effects for Group B Goal Attainment Scaling T-scores will be calculated according to best practice protocols, with charts created to visualize changes over time, providing individualized, client-centered program measurement for intervention.
Caregiver Participants (Aim 2) Pre-posttest comparisons will be made using MANCOVA approach for multiple dependent variables, with baseline Social Support Survey Instrument scores included as a covariate to control for social support effects on caregivers' emotion management abilities and adaptive coping skills demonstration.
Implementation Considerations
Anticipated Challenges and Mitigation Strategies
1. Irregular attendance: Intervention provided twice weekly to increase exposure opportunities
2. Recruitment and form completion: Additional incentives available if needed, with flexible meeting scheduling options
3. Unidentified diagnoses in preschool participants: Goal Attainment Scaling will address different performance skills and individualize program goals and activities
4. Language barriers: Adapted materials may be needed for caregivers not speaking English as first language, with YWCA community partner guidance for resolution strategies
Community Partnership The YWCA Early Learning Center serves as the on-site location, providing services to under-resourced families, almost all of whom have experienced homelessness and trauma. The YWCA does not currently provide occupational therapy services, making this collaboration an innovative approach to expanding trauma-informed care access in the community.
This study addresses major obstacles in engaging caregivers from under-resourced families who experience chronic stress due to underemployment, financial instability, unstable housing, unpredictable work schedules, and lack of financial resources including childcare. These caregivers cannot afford to volunteer time and efforts without appropriate supports and incentives.
Theoretical Framework The study is rooted in occupational therapy theory, resilience theory and science, with activities derived from existing literature. The program recognizes play as the primary occupation for preschoolers, introducing resiliency concepts through occupation-based intervention approaches. The trauma-informed care framework guides all intervention delivery, acknowledging the impact of trauma on development and the need for safe, supportive environments that promote healing and growth.
Expected Outcomes and Clinical Implications This pilot study will provide necessary data to understand effects of TIC-based intervention programs implemented by occupational therapists on social, emotional, mental health, coping abilities and life satisfaction in this vulnerable population. Results will inform parameters surrounding program implementation, including successes and challenges encountered, which are important for future effectiveness studies and translation into widespread clinical and community practice.
The study aligns with current funding agency priorities for mental health, resilience and trauma-informed care in pediatric populations, providing pilot data necessary for larger-scale funding applications that would support program implementation across multiple preschools and neighborhoods.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| AOTFIRG23DeBoth | OTHER_GRANT | American Occupational Therapy Foundation | View |