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

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

Interventions

BEHAVIORAL

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

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.

OTHER

Standard care/School Readiness Condition

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.

Sponsors & Collaborators

• Cleveland State University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

24 Months

Max Age

66 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-10-01

Primary Completion

2024-05-20

Completion

2024-09-30

Countries

• United States

Study Locations