Clinical Trial

Substance Use Prevention for Youth With Parents in Recovery

Active, Not Recruiting
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Summary
Risk for substance use disorder (SUD) begins early in the life course. Although preventing and decreasing illicit and nonmedical drug use among youth is an urgent public health priority, there are currently few evidence-based prevention strategies feasible for delivery in the primary care setting. The investigators propose a three-year plan to collect critical pilot data to pilot test and optimize a dyadic intervention that aims to increase family resilience, strengthen coping skills, help families plan for the future, and prevent youth SUD. The 'prototype' for the intervention approach is Family Talk, an evidence-based parent-youth dyadic intervention that can be delivered within the existing infrastructure of the patient-centered medical home. The investigators have made preliminary adaptations to the model in preparation for testing. To prepare for a subsequent efficacy study, a two-arm pilot randomized controlled trial of the intervention with 40 parent-youth dyads to optimize the intervention model will be conducted. The feasibility of the intervention will be evaluated. In addition, empiric estimates of study parameters to inform the planning of a fully powered randomized controlled trial and plausible intervention targets using semi-structured qualitative interviews will be obtained.
Protocol Amendment History 3 changes
critical Enrollment closed, study ongoing 2026-08-07
notable Primary completion pushed: 2026-03-31 -> 2026-07-31 2026-08-07
minor Completion pushed: 2026-03-31 -> 2026-12-31 2026-08-07
Trial Details
NCT Number NCT05397691
Lead Sponsor Brown University
Collaborators: National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
Conditions Substance Use Disorders
Enrollment 80 participants
Start Date 2024-08-29
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-06