Building Resilient Families

NCT05388864 | Recruiting

• 1 other identifier: 5180358
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Adverse Childhood Experiences

Keywords

adverse childhood experiences; pediatrics; prevention; preventive health services; quality improvement; childhood abuse and neglect

Outcome Measures

Primary Outcomes (1)

• Child Allostatic Load Index

  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.

  Change between baseline and visit 4 (1-year post-enrollment)

Secondary Outcomes (1)

• Pediatric Symptom Checklist (PSC)

  Change between baseline and visit 4 (1-year post-enrollment)

Study Arms (3)

Three-Tier Model

EXPERIMENTAL

130 children with ACEs who received well-child care by a trained provider will be enrolled in this group.

Behavioral: Three-Tier Model

Comparison Group

NO INTERVENTION

80 children without ACEs who received usual well-child care will be enrolled in this group.

Control Group

NO INTERVENTION

130 children with ACEs who received usual well-child care will be enrolled in this group.

Interventions

Three-Tier Model BEHAVIORAL

Families in the intervention will be counseled by a pediatric provider about ACEs, resilience, stress management, and healthy relationships. Families will also be referred to community health workers and parenting educators.

Three-Tier Model

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

RECRUITING

Study Officials

• Ariane Marie-Mitchell, MD, PhD, MPH

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariane Marie-Mitchell, MD, PhD, MPH

CONTACT

909-651-5672; amariemitchell@llu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The pediatric patients, their caregivers and teachers are blinded to arm type.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pediatric providers are randomized to training on the intervention or usual well-child care. Three groups of patients are recruited to evaluate the efficacy of the intervention: 1) Usual well-child care for children with no ACEs; 2) Usual well-child care for children with ACEs; and 3) Well-child care by providers trained in the intervention.

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: May 24, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)