About this trial
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.
Eligibility criteria
Qualifiers
Either reside in, or attend SFP meetings, within one of the 36 New Jersey communities with disproportionate levels of ACEs and substance use disorder (SUD) issues that are assigned to either the treatment or control conditions via the study's cluster randomized controlled trial design
One or more adult caregivers
One or more adolescents, ages 7 to 17
Caregiver provision of signed and dated informed consent form
Disqualifiers
Caregiver has previously completed SFP with one or more children, ages 7 to 17
Intellectual disabilities (i.e., cognitive impairments that would prohibit the completion of the SFP curriculum or data collection instruments)
Language difficulties (caregivers and children must read and understand spoken English)
Trial design
Treatments tested in this trial
- Strengthening Families Program + Family Advocate
- Strengthening Families Program
Treatment groups
Sponsors and collaborators
RTI International
Lead sponsor
New Jersey Prevention Network
Collaborator
RWJBarnabas Health Institute for Prevention and Recovery
Collaborator