Substance Use Prevention for Youth With Parents in Recovery

NCT05397691 | Recruiting

• 2 other identifiers: 20220035051R34DA052836-01A1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders

Keywords

Family Talk; Parent-youth dyad; Family functioning; Coping strategies

Outcome Measures

Primary Outcomes (5)

• Participation metrics

  The number of families approached and screened for the project, number ineligible, number refusing participation, and number ultimately enrolled will be assessed

  12 months

• Reasons for not enrolling

  An investigator created questionnaire will be obtain the reasons why eligible potential participants did not enroll in the study.

  12 months

• Study attrition rates

  The percent of participants will be calculated by dividing the number of participants that complete the study by the total number of participants enrolled.

  12 months

• Number of sessions

  The number of sessions delivered by the intervention providers will be tracked.

  throughout the study up to 12 months

• Person-time of sessions

  The total and average person time for sessions delivered by the intervention providers will be tracked.

  throughout the study up to 12 months

Secondary Outcomes (11)

• Youth substance use in preceding 90 days

  90 days

• Youth substance use screening

  12 months

• Family Communication

  3 months, 6 months, 12 months

• Family Functioning

  3 months, 6 months, 12 months

• Depression

  3 months, 6 months, 12 months

Study Arms (2)

Intervention refinement arm

EXPERIMENTAL

20 parent-youth \[12-18 years old\] dyads will be randomized to this arm and receive the Modified Family Talk intervention.

Other: Modified Family Talk

Parameter estimation arm

EXPERIMENTAL

20 parent-youth dyads randomized to this control-like arm will receive current best practice care in the patient-centered medical home

Other: Control-like parameter estimation

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.

Intervention refinement arm

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.

Parameter estimation arm

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years without diagnosed SUD
• Comfortable speaking English or Spanish
• years or older
• Receiving treatment for SUD
• Receiving substance use care in the CODAC system
• Comfortable speaking English or Spanish

You may not qualify if:

• Presence of acute family crisis, such as recent death, incarceration, separation, divorce, or other stressor
• Parent or youth with cognitive limitation or intellectual disability

Sponsors & Collaborators

• Brown University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

CODAC

Pawtucket, Rhode Island, 02904, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Caroline J Kistin, MD MSc

  Brown University School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline J Kistin, MD MSc

CONTACT

4018632236; caroline_kistin@brown.edu

Jocelyn Antonio, MPH

CONTACT

4018632259; jocelyn_antonio@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 31, 2022
• Study Start: August 29, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)