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Substance Use Prevention for Youth With Parents in Recovery

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Brown University

Status

Enrolling

Conditions

Substance Use Disorders

Treatments

Other: Control-like parameter estimation
Other: Modified Family Talk

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05397691
2022003505
1R34DA052836-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for youth:

  • 12-18 years without diagnosed SUD
  • Comfortable speaking English or Spanish

Inclusion Criteria for parent:

  • 18 years or older
  • Receiving treatment for SUD
  • Receiving substance use care in the CODAC system
  • Comfortable speaking English or Spanish

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Intervention refinement arm
Experimental group
Description:
20 parent-youth \[12-18 years old\] dyads will be randomized to this arm and receive the Modified Family Talk intervention.
Treatment:
Other: Modified Family Talk
Parameter estimation arm
Experimental group
Description:
20 parent-youth dyads randomized to this control-like arm will receive current best practice care in the patient-centered medical home
Treatment:
Other: Control-like parameter estimation

Trial contacts and locations

1

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Central trial contact

Jocelyn Antonio, MPH; Caroline J Kistin, MD MSc

Data sourced from clinicaltrials.gov

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