Recruiting

Observational Study

Sponsor:

Loma Linda University

Code:

NCT05388864

Conditions

Adverse Childhood Experiences

Eligibility Criteria

Sex: All

Age: 3 - 11

Healthy Volunteers: Accepted

Interventions

Three-Tier Model

Study Details

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.

Conditions

Adverse Childhood Experiences

Study ID

NCT05388864

Start date

May 24, 2022

Status verified date

Jun, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 11

Healthy Volunteers: Accepted

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

Study Design

Enrollment

340 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Three-Tier Model

130 children with ACEs who received well-child care by a trained provider will be enrolled in this group.

no intervention: Comparison Group

80 children without ACEs who received usual well-child care will be enrolled in this group.

no intervention: Control Group

130 children with ACEs who received usual well-child care will be enrolled in this group.

Interventions

Three-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.

Primary outcome measure

  • Child Allostatic Load Index [ Time Frame: Change between baseline and visit 4 (1-year post-enrollment) ]

Central Contacts and Locations

Central contacts

Ariane Marie-Mitchell, MD, PhD, MPH

909-651-5672amariemitchell@llu.edu

Locations

Loma Linda University

Recruiting

Loma Linda, California, United States, 92354

Principal Investigator:

Ariane Marie-Mitchell, MD, PhD, MPH

More Information

Sponsor

Loma Linda University

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Loma Linda University on 2026-06-09.