Actively Recruiting

Phase Not Applicable
Age: 3Years - 11Years
All Genders
Healthy Volunteers
NCT05388864

Building Resilient Families

Led by Loma Linda University · Updated on 2025-10-29

340

Participants Needed

1

Research Sites

257 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Building Resilient Families

Who Can Participate

Age: 3Years - 11Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Ages 3-11
  • Seen for a well-child visit at a participating pediatric clinic
Not Eligible

You will not qualify if you...

  • Younger than 3 years or older than 11 years of age
  • Significant congenital medical problems
  • Previous participation in parenting program within the last 12 months
  • Sibling enrollment in current study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Loma Linda University

Loma Linda, California, United States, 92354

Actively Recruiting

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Research Team

A

Ariane Marie-Mitchell, MD, PhD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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