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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05388864
Other study ID # 5180358
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 24, 2022
Est. completion date May 2027

Study information

Verified date October 2023
Source Loma Linda University
Contact Ariane Marie-Mitchell, MD, PhD, MPH
Phone 909-651-5672
Email amariemitchell@llu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 340
Est. completion date May 2027
Est. primary completion date May 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 11 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Loma Linda University Loma Linda California

Sponsors (1)

Lead Sponsor Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Child Allostatic Load Index A composite measurement that combines biometric data, neuroendocrine and immune markers, and executive function to determine whether the intervention lowers physiologic stress for children with ACEs. Each group will be followed over one year and growth curves will be analyzed to compare change in physiologic stress between baseline and final follow-up. Change between baseline and visit 4 (1-year post-enrollment)
Secondary Pediatric Symptom Checklist (PSC) The Pediatric Symptom Checklist is a psychosocial screen designed to indicate psychological impairment.
For participants ages 3-5, a total score of 24 indicates psychological impairment.
For participants ages 6-11, a total score of 28 indicates psychological impairment.
Change between baseline and visit 4 (1-year post-enrollment)
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