Building Resilient Families

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-Component Intervention to Strengthen Families With Adverse Childhood Experiences (ACEs)

Conditions
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Adverse Childhood Experiences

Intervention / Treatment
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* Behavioral: Three-Tier Model


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Three-Tier Model<br>130 children with ACEs who received well-child care by a trained provider will be enrolled in this group. | Behavioral: Three-Tier Model<br>* 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.<br>|
| No Intervention: Comparison Group<br>80 children without ACEs who received usual well-child care will be enrolled in this group. | |
| No Intervention: Control Group<br>130 children with ACEs who received usual well-child care will be enrolled in this group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adverse childhood experiences, pediatrics, prevention, preventive health services, quality improvement, childhood abuse and neglect