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Three-Tier Support Model for Adverse Childhood Experiences

N/A
Waitlist Available
Led By Ariane Marie-Mitchell, MD, PhD, MPH
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 3-11
Be younger than 18 years old
Must not have
< 3 years or >11 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline and visit 4 (1-year post-enrollment)
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying whether a combination of different types of support can improve outcomes for children with ACEs. Families with children between the ages of 3 and 11 who have recently seen a pediatrician are invited to participate.

Who is the study for?
This trial is for children aged 3-11 who have experienced adverse childhood events (ACEs) and are generally healthy. They must have recently had a well-child visit at a participating clinic. Children with significant congenital medical issues, those outside the age range, siblings already in the study, or those enrolled in a parenting program within the last year cannot participate.
What is being tested?
The 'Building Resilient Families' trial tests a Three-Tier Model intervention to help families with ACEs by using pediatricians, community health workers, and parenting educators trained in resilience-building curriculum. It's a randomized controlled trial comparing this model against usual care to see if it reduces toxic stress and improves health outcomes over time.
What are the potential side effects?
Since this intervention involves educational and support services rather than medication, traditional side effects are not expected. However, there may be emotional or psychological impacts from discussing sensitive topics which will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between the ages of 3 and 11.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am either younger than 3 years old or older than 11 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline and visit 4 (1-year post-enrollment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline and visit 4 (1-year post-enrollment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Child Allostatic Load Index
Secondary study objectives
Pediatric Symptom Checklist (PSC)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Three-Tier ModelExperimental Treatment1 Intervention
130 children with ACEs who received well-child care by a trained provider will be enrolled in this group.
Group II: Comparison GroupActive Control1 Intervention
80 children without ACEs who received usual well-child care will be enrolled in this group.
Group III: Control GroupActive Control1 Intervention
130 children with ACEs who received usual well-child care will be enrolled in this group.

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
316 Previous Clinical Trials
266,335 Total Patients Enrolled
Ariane Marie-Mitchell, MD, PhD, MPHPrincipal InvestigatorLoma Linda University

Media Library

Three-Tier Model Clinical Trial Eligibility Overview. Trial Name: NCT05388864 — N/A
Adverse Childhood Experiences Research Study Groups: Three-Tier Model, Comparison Group, Control Group
Adverse Childhood Experiences Clinical Trial 2023: Three-Tier Model Highlights & Side Effects. Trial Name: NCT05388864 — N/A
Three-Tier Model 2023 Treatment Timeline for Medical Study. Trial Name: NCT05388864 — N/A
Adverse Childhood Experiences Patient Testimony for trial: Trial Name: NCT05388864 — N/A
~116 spots leftby May 2026
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