NCT05397691

Substance Use Prevention for Youth With Parents in Recovery

Substance Use Prevention for Youth With Parents in Recovery: A Pilot Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Within the context of a pilot randomized controlled trial, the objectives are to: 1. Optimize the content and delivery of the intervention through an iterative series of quality improvement cycles informed by structured feedback from parents, youth, and intervention providers after each session; 2. Field test study logistics, including participant recruitment, willingness to consent to a randomized trial; loss to follow-up; the acceptability and feasibility of the study measures; and 3. Obtain empiric estimates of study parameters to inform future clinical trial design, including within-group standard deviation of continuous measures; correlations of repeated measures; and proportion of control group subjects who experience each outcome. The products at the end of the pilot study will be an optimized intervention model, developed with parent and youth input and ready for efficacy testing; and a set of putative intervention targets ready to be tested in the subsequent trial. The ultimate goal is to develop an effective approach to youth substance use prevention, delivered within the infrastructure of the patient-centered medical home. If successful, this trajectory of work has the potential to identify a novel, family-centered approach to substance use disorder prevention for a high-risk population of youth whose parents are in recovery.

Conditions

• Substance Use Disorders

Interventions

Type	Name	Description
OTHER	Modified Family Talk	The Modified Family Talk intervention consists of six modules, each lasting approximately 60 minutes. Family Talk is intended to be delivered over a period of 12 weeks, with meetings occurring every 1-2 weeks.
OTHER	Control-like parameter estimation	Parameter estimation is designed to emulate best practices around comprehensive, high quality, patient-centered care for adults and youth. Participants will have access to collaborative adult Office Based Addiction Treatment (OBAT) clinical services, multidisciplinary adolescent primary care clinics with co-located adolescent substance use specialists, high quality social work services, integrated behavioral health, and access to patient navigators for assistance connecting to community resources.

Timeline

• Start date: 2024-08-29
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2022-05-31
• Last updated: 2024-12-11

Locations

1 site across 1 country: United States