Three-Tier Model for Adverse Childhood Experiences

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Loma Linda University, Loma Linda, CA
Adverse Childhood Experiences
Three-Tier Model - Behavioral
Eligibility
< 18
All Sexes
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Study 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.

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Change between baseline and visit 4 (1-year post-enrollment)

Change between baseline and visit 4 (1-year post-enrollment)
Child Allostatic Load Index
Pediatric Symptom Checklist (PSC)

Trial Safety

Trial Design

3 Treatment Groups

Control Group
1 of 3
Comparison Group
1 of 3
Three-Tier Model
1 of 3
Active Control
Experimental Treatment

340 Total Participants · 3 Treatment Groups

Primary Treatment: Three-Tier Model · No Placebo Group · N/A

Three-Tier Model
Behavioral
Experimental Group · 1 Intervention: Three-Tier Model · Intervention Types: Behavioral
Control GroupNoIntervention Group · 1 Intervention: Control Group · Intervention Types:
Comparison GroupNoIntervention Group · 1 Intervention: Comparison Group · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change between baseline and visit 4 (1-year post-enrollment)
Closest Location: Loma Linda University · Loma Linda, CA
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2009First Recorded Clinical Trial
1 TrialsResearching Adverse Childhood Experiences
100 CompletedClinical Trials

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
281 Previous Clinical Trials
256,800 Total Patients Enrolled
Ariane Marie-Mitchell, MD, PhD, MPHPrincipal InvestigatorLoma Linda University

Eligibility Criteria

Age < 18 · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.