Building Resilient Families

Not Applicable

Recruiting

• Conditions: Adverse Childhood Experiences
• Interventions: Behavioral: Three-Tier Model

• Registration Number: NCT05388864
• Lead Sponsor: Loma Linda University

Brief Summary

Prior research suggests that it is possible to improve health outcomes in children with ACEs through multi-component interventions. The challenge for most communities is that health and education systems are fragmented and fail to accommodate families based upon different levels of need. This study utilizes cross-sectoral partnerships to mobilize three vectors (pediatricians, community health workers and parenting educators) to optimize the delivery of vital information and resources to a diverse population of families with ACEs. All vectors are trained in an evidence-informed curriculum to strengthen families and build youth resilience. The study design is a randomized controlled trial of 340 families of children between the ages of 3 to 11 who are generally healthy and have recently seen a pediatrician for a well-child visit.

To evaluate the efficacy of this intervention, pediatric patients are invited to participate in repeat evaluations within 2 weeks, 3 months, 6 months, and 12 months after their well-child visit. The study will evaluate the following: 1) the association between Child-ACE scores and biomarkers of toxic stress at baseline in children age 3-11 years old; 2) whether the intervention reduces toxic stress and child health and psychosocial problems at follow-up for children with ACEs compared to usual well-child care for children with ACEs; and 3) the impact of mediating and moderating variables. These results will demonstrate that for families with ACEs the intervention will decrease toxic stress associated with ACEs, improve health outcomes, and reduce health disparities.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-19
• Study Start: 2022-05-24
• Study First Posted: 2022-05-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2026-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

• Ages 3-11
• Seen for a well-child visit at a participating pediatric clinic

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Exclusion Criteria

• < 3 years or >11 years of age
• Significant congenital medical problems
• Previous participation in parenting program (last 12 months)
• Sibling enrollment in current study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Three-Tier Model	Three-Tier Model	130 children with ACEs who received well-child care by a trained provider will be enrolled in this group.

Primary Outcome Measures

Name	Time	Method
Child Allostatic Load Index	Change between baseline and visit 4 (1-year post-enrollment)	A composite measurement that combines biometric data, neuroendocrine and immune markers, and executive function to determine whether the intervention lowers physiologic stress for children with ACEs. Each group will be followed over one year and growth curves will be analyzed to compare change in physiologic stress between baseline and final follow-up.

Secondary Outcome Measures

Name	Time	Method
Pediatric Symptom Checklist (PSC)	Change between baseline and visit 4 (1-year post-enrollment)	The Pediatric Symptom Checklist is a psychosocial screen designed to indicate psychological impairment.; For participants ages 3-5, a total score of 24 indicates psychological impairment.; For participants ages 6-11, a total score of 28 indicates psychological impairment.

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States