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Building Resilient Families

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05388864
Enrollment
340
Registered
2022-05-24
Start date
2022-05-24
Completion date
2028-05-01
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Childhood Experiences

Keywords

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

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.

Interventions

BEHAVIORALThree-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.

Sponsors

Loma Linda University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

The pediatric patients, their caregivers and teachers are blinded to arm type.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
3 Years to 11 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Child Allostatic Load IndexChange 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

MeasureTime frameDescription
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.

Countries

United States

Contacts

CONTACTAriane Marie-Mitchell, MD, PhD, MPH
amariemitchell@llu.edu909-651-5672
PRINCIPAL_INVESTIGATORAriane Marie-Mitchell, MD, PhD, MPH

Loma Linda University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026