Purpose

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.

Condition

Eligibility

Eligible Ages
Between 3 Years and 11 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Pediatric providers are randomized to training on the intervention or usual well-child care. Three groups of patients are recruited to evaluate the efficacy of the intervention: 1) Usual well-child care for children with no ACEs; 2) Usual well-child care for children with ACEs; and 3) Well-child care by providers trained in the intervention.
Primary Purpose
Prevention
Masking
Single (Participant)
Masking Description
The pediatric patients, their caregivers and teachers are blinded to arm type.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Three-Tier Model
130 children with ACEs who received well-child care by a trained provider will be enrolled in this group.
  • Behavioral: 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.
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.

Recruiting Locations

Loma Linda University
Loma Linda, California 92354
Contact:
Ariane Marie-Mitchell, MD, PhD, MPH

More Details

Status
Recruiting
Sponsor
Loma Linda University

Study Contact

Ariane Marie-Mitchell, MD, PhD, MPH
909-651-5672
amariemitchell@llu.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.