The Building Resilience Program: Examining Self-Regulation, Behavior, and Resilience in Under-Resourced Preschoolers With ACEs

NCT07170605 | Completed

• 2 other identifiers: IRB-FY2022-23AOTFIRG23DeBoth
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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)

Conditions

Preschool Age Children; Preschool Education; Adverse Childhood Experience; Mental Health; Resilience; Minority Groups

Keywords

preschool; occupational therapy; ACEs; trauma; resilience; intervention; GAS

Outcome Measures

Primary Outcomes (6)

• Resilience and Engagement

  Patient-Reported Outcomes Measurement Information System (PROMIS) Curiosity and Persistence measures (parent proxy report, scores calculated as standardized scores for analysis). Original scoring for all is 1-5 scale (Never, Rarely, Sometimes, Often, Always). Higher scores (always/5) are considered higher and more characteristic of a child with characteristics of being resilient.

  Measured at baseline, week 8 (end of first intervention and wait-list period), and finally at week 16 (end of second intervention period for the waitlist group and follow-up period for the first intervention group)

• Self-Regulation

  Patient-Reported Outcomes Measurement Information System (PROMIS) Flexibility and Frustration Tolerance measures (parent proxy report, scores calculated as standardized scores for analysis). Original scoring for all is 1-5 scale (Never, Rarely, Sometimes, Often, Always). Higher scores (always/5) are considered higher and more characteristic of a child with characteristics of being resilient.

  Measured at baseline, week 8 (end of first intervention and wait-list period), and finally at week 16 (end of second intervention period for the waitlist group and follow-up period for the first intervention group)

• Emotional Health

  Measured using NIH Toolbox parent proxy report measures for (1) Positive Affect; (2) Anger; (3) Fear; (4) Sadness. Positive Affect rated on 1-4 scale: (1) Not at all (1) A little bit (2) Somewhat (3) Quite a bit and (4) Very much. Anger rated on 1-3 scale: (1) Never or not true, (2) Sometimes or somewhat true, (3) Often or very true. Fear and Sadness rated on a 0-2 scale, (0) Never or not true, (1) Sometimes or somewhat true, (2) Often or very true. All were converted to standardized scores for analysis according to the NIH Toolbox directions for scoring.

  Measured at baseline, week 8 (end of first intervention and wait-list period), and finally at week 16 (end of second intervention period for the waitlist group and follow-up period for the first intervention group)

• Quality of Life/Life Satisfaction

  NIH Toolbox measures for General Life Satisfaction parent proxy report measured on a 1-5 scale of (1) Strongly Disagree, (2) Disagree, (3) Neither Agree nor Disagree, (4) Agree, (5) Strongly Agree. All scores converted to standardized scores for analysis according to the NIH Toolbox scoring guide.

  Measured at baseline, week 8 (end of first intervention and wait-list period), and finally at week 16 (end of second intervention period for the waitlist group and follow-up period for the first intervention group).

• Quality of Life (QoL)

  QoL as measured by parent proxy report on the PedsQL including the following domains: Physical, Emotional, Social, School, and a Composite score. Each of these was rated on a scale of 0-4, (0) Never, (1) Almost Never (2) Sometimes (3) Often (4) Almost Always. Scores were translated into standardized scores for analysis according to PedsQL scoring guidelines.

  Measured at baseline, week 8 (end of first intervention and wait-list period), and finally at week 16 (end of second intervention period for the waitlist group and follow-up period for the first intervention group)

• Individualized Goal Attainment Scaling (GAS) goals

  Goals were created for each individual participant related to: behavior, engagement/participation and resilience. Goal Attainment Scaling (GAS) was used to track progress and attainment throughout the project, recorded by members of the research team. Scoring was consistent with typical GAS ratings: a 5-point scale, ranging from -2 to +2, to assess progress toward a specific goal. The 0 level represents the expected outcome with intervention, while -1 and -2 indicate less-than-expected progress or a return to a baseline, and +1 and +2 show progress that exceeds expectations. These ratings were converted to T-scores for analysis (mean 50, SD 10).

  GAS scores recorded at baseline, and then 3x per week for 8 weeks during the intervention condition, and 2x per week during the waitlist control condition, across all GAS categories (behavior, engagement/participation and resilience).

Secondary Outcomes (3)

• Caregiver - Resilience

  Measurements taken and baseline and then post-intervention (either week 8 or 16 depending on group assignment)

• Caregiver Well-Being

  Measurement taken at baseline and again post-caregiver intervention at week 8 or week 16, depending on group assignment for their child (caregivers participated in intervention during same 8-week timeframe as their child).

• Caregiver Perceptions

  Caregivers and educators provided consent at baseline, interviews completed after program completed between weeks 16-20, based on scheduling limitations and availability. Interviews schedule for 60 minutes.

Study Arms (2)

Intervention - children receiving the 8-week Building Resilience Program

ACTIVE COMPARATOR

Out-of-classroom, small group intervention led by occupational therapists, implementation of the manualized BRP

Behavioral: Mental health, positive coping strategies promoting self-regulation and adaptive skills

Standard care or school readiness condition

PLACEBO COMPARATOR

This condition for the waitlist control condition was used to account for positive effects that might have been the result of interactions with an occupational therapist. This was designed specifically NOT to overlap with the constructs of the intervention condition and focused on other, more basic elements of school readiness unrelated to mental health, social emotional learning or trauma.

Other: Standard care/School Readiness Condition

Interventions

Mental health, positive coping strategies promoting self-regulation and adaptive skills BEHAVIORAL

The BRP manual includes eight modules delivered over eight weeks: introduction to resilience, identifying and communicating emotions, emotional regulation, coping strategies for self-regulation (2 parts), breath awareness/meditation, applying positive coping strategies, and review/group session with caregiver. Sessions utilize play as the primary occupation, introducing resiliency concepts through 40-60 minute sessions three times each week to provide repetition and application of concepts with multiple opportunities to review, repeat and apply. Each BRP session will be implemented by two occupational therapists, one occupational therapy student, and one YWCA staff member. Group size has been determined to approach therapeutic limits with 8-10 students, requiring this staffing ratio for optimal intervention delivery.

Also known as: Building Resilience Program

Intervention - children receiving the 8-week Building Resilience Program

Standard care/School Readiness Condition OTHER

The School Readiness protocol supplements existing preschool curriculum while mitigating positive researcher interaction effects. Sessions start with a song and warm-up, including active listening, sharing and turn-taking while targeting different domains each week: perceptual motor, fine motor (tool use), fine motor (coloring), problem solving, teamwork, coordination and motor planning, problem solving (teams), and gross and fine motor (teams). These skills were selected based on feasibility study observations and designed not to overlap with social-emotional skills embedded in the BRP.

Standard care or school readiness condition

Eligibility Criteria

• Age: 24 Months - 66 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Enrolled at the YWCA Early Learning Center partner facility, between the ages of 24 months and 66 months at the time of enrollment

You may not qualify if:

• limited English-speaking fluency (i.e., required a translator), or parent-reported cognitive delays or medical conditions that would prevent independent participation in the program groups

Sponsors & Collaborators

• Cleveland State University: lead

Study Sites (1)

Cleveland State University

Cleveland, Ohio, 44113, United States

Location

Related Publications (6)

• Lynch, B. P., Brokamp, K. M., Scheerer, C. R., Bishop, M., Stauble, L., Hagedorn, B., & Endres, L. (2021). Outcomes of Occupational Therapy in Trauma-Informed Care. Journal of Occupational Therapy, Schools, & Early Intervention, 1-17.

  BACKGROUND

• Pitt, C., Luger, R., Bullen, A., Phillips, D., & Geiger, M. (2013). Parents as partners: Building collaborations to support the development of school readiness skills in under-resourced communities. South African Journal of Education, 33(4), 1-14.

  BACKGROUND

• Logan B, Jegatheesan D, Viecelli A, Pascoe E, Hubbard R. Goal attainment scaling as an outcome measure for randomised controlled trials: a scoping review. BMJ Open. 2022 Jul 22;12(7):e063061. doi: 10.1136/bmjopen-2022-063061.

  PMID: 35868829 BACKGROUND

• Liu M, Luong L, Lachaud J, Edalati H, Reeves A, Hwang SW. Adverse childhood experiences and related outcomes among adults experiencing homelessness: a systematic review and meta-analysis. Lancet Public Health. 2021 Nov;6(11):e836-e847. doi: 10.1016/S2468-2667(21)00189-4. Epub 2021 Sep 30.

  PMID: 34599894 BACKGROUND

• Crouch, E., Jones, J., Strompolis, M., & Merrick, M. (2020). Examining the association between ACEs, childhood poverty and neglect, and physical and mental health: Data from two state samples. Children and Youth Services Review, 116, 105155.

  BACKGROUND

• Creamer, J., Shrider, E. A., Burns, K., & Chen, F. (2022). Poverty in the United States: 2021. US Census Bureau.

  BACKGROUND

Related Links

• Study protocols for the Child and Youth Resilience Measure (CYRM) and Adult Resilience Measure (ARM)

MeSH Terms

Conditions

Psychological Well-Being; Wounds and Injuries

Interventions

Mental Health

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Health; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study uses a randomized two-group pre-posttest comparison waitlist design. Condition 1 is intervention, and condition 2 is "standard care"

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 12, 2025
• Study Start: October 1, 2023
• Primary Completion: May 20, 2024
• Study Completion: September 30, 2024
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)