Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program
NCT06236100 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360
Last updated 2026-05-05
Summary
Primary Objective: Conduct a rigorous evaluation of a prevention-based intervention designed to mitigate the harms of adverse childhood experiences (ACEs) exposure and prevent future ACEs, substance use, and overdose within 36 communities experiencing a disproportionate burden of substance use and ACEs.
The study has three aims: (1) use a cluster randomized controlled trial to test effectiveness of the Strengthening Families Program (SFP) + Family Advocate (FA) intervention on substance use, overdose, and ACEs in 18 communities compared with SFP-only in 18 communities; (2) conduct a robust process evaluation informed by the Consolidated Framework for Implementation Research (CFIR) to explore implementation barriers and facilitators; and (3) conduct a cost evaluation to accurately estimate the costs required to implement SFP and SFP+FA and assess the cost-effectiveness of SFP+FA relative to SFP alone. Findings will provide a roadmap about the best ways to help disproportionately affected communities prevent substance use, overdose, and ACEs.
Conditions
- Substance-Related Disorders
- Adverse Childhood Experiences
Interventions
- BEHAVIORAL
-
Strengthening Families Program + Family Advocate
This intervention will integrate clinically trained, trauma-informed Family Advocates (FA) into the established, evidence-based Strengthening Families Program (SFP). Families will participate in the SFP7-17 curriculum, which consists of 11 sessions over 10-14 weeks. FAs will assist families in accessing community resources for substance use and Adverse Childhood Experiences (ACE) prevention and treatment.
- BEHAVIORAL
-
Strengthening Families Program
This intervention consists of the SFP7-17 Group Class Curriculum. Families will participate in the SFP7-17 curriculum, which consists of 11 sessions over 10-14 weeks.
Sponsors & Collaborators
-
New Jersey Prevention Network
collaborator UNKNOWN -
RWJBarnabas Health Institute for Prevention and Recovery
collaborator UNKNOWN -
RTI International
lead OTHER
Principal Investigators
-
Phillip W. Graham, DrPH · RTI International
-
Dallas J Elgin, PhD · RTI International
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 7 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-11-29
- Primary Completion
- 2026-10-31
- Completion
- 2027-09-29
Countries
- United States
Study Locations
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