← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between baseline and visit 4 (1-year post-enrollment)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between baseline and visit 4 (1-year post-enrollment)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Child Allostatic Load Index

Secondary outcome measures

Pediatric Symptom Checklist (PSC)

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor

306 Previous Clinical Trials

260,648 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total enrolment number for this medical trial?

"Affirmative. Per the information on clinicaltrials.gov, this medical trial is recruiting participants as of October 7th 2022. It was initially posted to the website back in May 24th 2022 and needs 340 individuals from 1 site."

Answered by AI

Is the registration process still ongoing for this clinical trial?

"According to clinicaltrials.gov, the trial is actively recruiting participants since it was initially posted on May 24th 2022 and updated most recently on October 7th 2022."

Answered by AI

To what demographic is this research endeavor best suited?

"The current trial is seeking 340 children (ages 3-11) who have had adverse childhood experiences. Aspiring participants must have attended a well check up at one of the participating pediatric clinics."

Answered by AI

Is this clinical trial open to octogenarians?

"As reflected in the eligibility requirements, those wishing to enroll must be between 3 and 11 years old."

Answered by AI

Who else is applying?

What state do they live in?

California

What site did they apply to?

Loma Linda University

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have suffered from depression and anxiety since experiencing childhood abuse. These conditions were exacerbated after my husband was shot to death in 2015 and I find that as I age, I am becoming less emotionally resilient and more rigid.

PatientReceived 1 prior treatment

Recent research and studies

clinicaltrials.govStudy

Building Resilient Families

Ariane Marie-Mitchell 2022. "Building Resilient Families". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05388864.

All > Prevention