Substance Use Prevention for Youth With Parents in Recovery

Part of paid clinical trials in Pawtucket, Rhode Island.

Sponsor
Brown University
Study ID
NCT05397691
Status
Recruiting
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Conditions

  • Substance Use Disorders

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Modified Family Talk — OTHER
    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.
  • Control-like parameter estimation — OTHER
    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.

Study Details

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.

Key Dates

Start date
Aug 29, 2024
Status verified
Dec 2024
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

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

Primary Outcome Measure

Participation metrics [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CODACPawtucketRhode Island02904
Lily Pike, MD

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CODAC· Pawtucket, RI

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