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NCT Number: NCT05388864

Building Resilient Families

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.

Recruiting

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Key information

Age range

3 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University

Loma Linda, California, 92354, United States

Location status: Recruiting

Location contact

Ariane Marie-Mitchell, MD, PhD, MPH

CONTACT

Ariane Marie-Mitchell, MD, PhD, MPH

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Child Allostatic Load Index

    Time frame: 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 outcomes

  1. Pediatric Symptom Checklist (PSC)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ariane Marie-Mitchell, MD, PhD, MPH

CONTACT

[email protected]

909-651-5672

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
May 24, 2022
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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