Substance Use Prevention for Youth With Parents in Recovery: A Pilot Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Substance Use Disorders
- Sponsor
- Brown University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Participation metrics
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Presence of acute family crisis, such as recent death, incarceration, separation, divorce, or other stressor
- •Parent or youth with cognitive limitation or intellectual disability
Outcomes
Primary Outcomes
Participation metrics
Time Frame: 12 months
The number of families approached and screened for the project, number ineligible, number refusing participation, and number ultimately enrolled will be assessed
Reasons for not enrolling
Time Frame: 12 months
An investigator created questionnaire will be obtain the reasons why eligible potential participants did not enroll in the study.
Study attrition rates
Time Frame: 12 months
The percent of participants will be calculated by dividing the number of participants that complete the study by the total number of participants enrolled.
Person-time of sessions
Time Frame: throughout the study up to 12 months
The total and average person time for sessions delivered by the intervention providers will be tracked.
Number of sessions
Time Frame: throughout the study up to 12 months
The number of sessions delivered by the intervention providers will be tracked.
Secondary Outcomes
- Depression(3 months, 6 months, 12 months)
- Family Functioning(3 months, 6 months, 12 months)
- Perceived Stress(3 months, 6 months, 12 months)
- Problem solving skills(3 months, 6 months, 12 months)
- Youth perceptions of peer, sibling, parental substance use(3 months, 6 months, 12 months)
- Social support(3 months, 6 months, 12 months)
- Youth substance use in preceding 90 days(90 days)
- Family Communication(3 months, 6 months, 12 months)
- Types of coping strategies(3 months, 6 months, 12 months)
- Youth substance use screening(12 months)
- Self-efficacy coping strategies(3 months, 6 months, 12 months)