Building Resilient Families

A Multi-Component Intervention to Strengthen Families With Adverse Childhood Experiences (ACEs)

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.

Study Overview

• Status: Recruiting
• Conditions: Adverse Childhood Experiences
• Intervention / Treatment: Behavioral: Three-Tier Model

• Study Type: Interventional
• Enrollment (Estimated): 340
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ariane Marie-Mitchell, MD, PhD, MPH; Phone Number: 909-651-5672; Email: amariemitchell@llu.edu

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Recruiting
      • Loma Linda University
      • Contact: Ariane Marie-Mitchell, MD, PhD, MPH
      • Principal Investigator: Ariane Marie-Mitchell, MD, PhD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 9 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Three-Tier Model; 130 children with ACEs who received well-child care by a trained provider will be enrolled in this group.	Behavioral: Three-Tier Model; 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.
No Intervention: Comparison Group; 80 children without ACEs who received usual well-child care will be enrolled in this group.
No Intervention: Control Group; 130 children with ACEs who received usual well-child care will be enrolled in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Symptom Checklist (PSC)	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.	Change between baseline and visit 4 (1-year post-enrollment)

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Ariane Marie-Mitchell, MD, PhD, MPH, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2022
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: pediatrics; prevention; quality improvement; adverse childhood experiences; preventive health services; childhood abuse and neglect
• Other Study ID Numbers: 5180358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No