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Clinical Trials/NCT04400227
NCT04400227
Withdrawn
Not Applicable

Pilot Study of Family Talk to Prevent Youth Substance Use

Boston Medical Center0 sitesJuly 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Use Disorders
Sponsor
Boston Medical Center
Primary Endpoint
Change in youth substance use based on the Timeline Followback Interview
Status
Withdrawn
Last Updated
3 years ago

Overview

Brief Summary

Family Talk, an evidence-based parent-youth dyadic intervention, is a promising approach to improving substance use outcomes for high-risk families, and its structure lends itself to delivery by existing personnel within an Office-Based Addiction Treatment (OBAT) model of care. The investigators propose a single-arm pilot study with 25 parent-youth dyads through which a rapid cycle performance improvement approach will be employed to adapt and optimize the content and delivery of the embedded Family Talk prevention strategy. The investigators will field-test relevant baseline and outcome measures and will use qualitative methodology to identify key modifications to the intervention and generate hypotheses for how the prevention strategy may impact youth and family outcomes and prevent youth substance use. Information from this study will inform a subsequent pilot randomized controlled trial of the intervention to prevent substance use for youth whose parents are in recovery from SUD (substance use disorder).

Registry
clinicaltrials.gov
Start Date
July 2022
End Date
June 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Participating parent is receiving treatment for substance use disorder
  • Participating youth is between the ages of 12-25
  • Participating youth has no diagnosis of substance use disorder
  • Parent and youth are both comfortable communicating in English or Spanish

Exclusion Criteria

  • Acute family crisis, such as recent or current incarceration, divorce, adult return to substance use, or traumatic event
  • Adult or youth with cognitive limitation or intellectual disability

Outcomes

Primary Outcomes

Change in youth substance use based on the Timeline Followback Interview

Time Frame: baseline, 6 months

The Timeline Followback Interview (TLFB) will be used to estimate substance use. It uses a calendar and asks the participant to indicate whether they used substances on each of the days listed for the last 3 months. No score is given for the measure. However, more days of use is associated with adverse health outcomes.

Youth substance use based on the Timeline Followback Interview at 4 months

Time Frame: 4 months

The Timeline Followback Interview (TLFB) will be used to estimate substance use. It uses a calendar and asks the participant to indicate whether they used substances on each of the days listed for the last 3 months. No score is given for the measure. However, more days of use is associated with adverse health outcomes.

Youth substance use based on the Screening to Brief Intervention Tool at 4 months

Time Frame: 4 months

The Screening to Brief Intervention instrument, or S2BI, is a 7-item instrument that asks about tobacco, alcohol, marijuana, prescribed drugs, inhalants, illegal drugs, and herbs/synthetic drugs. Responses for each substance can be 'never', 'once or twice', 'monthly', of 'weekly or more'. The result range from "no reported use," "lower risk," or "higher risk." For the lower and higher risk categories the intervention provides guidance for developing an action plan for each response category.

Change in Youth substance use based on the Screening to Brief Intervention Tool

Time Frame: baseline, 6 months

The Screening to Brief Intervention instrument, or S2BI, is a 7-item instrument that asks about tobacco, alcohol, marijuana, prescribed drugs, inhalants, illegal drugs, and herbs/synthetic drugs. Responses for each substance can be 'never', 'once or twice', 'monthly', of 'weekly or more'. The result range from "no reported use," "lower risk," or "higher risk." For the lower and higher risk categories the intervention provides guidance for developing an action plan for each response category.

Youth substance use based on the Timeline Followback Interview at 2 months

Time Frame: 2 months

The Timeline Followback Interview (TLFB) will be used to estimate substance use. It uses a calendar and asks the participant to indicate whether they used substances on each of the days listed for the last 3 months. No score is given for the measure. However, more days of use is associated with adverse health outcomes.

Youth substance use based on the Screening to Brief Intervention Tool at 2 months

Time Frame: 2 months

The Screening to Brief Intervention instrument, or S2BI, is a 7-item instrument that asks about tobacco, alcohol, marijuana, prescribed drugs, inhalants, illegal drugs, and herbs/synthetic drugs. Responses for each substance can be 'never', 'once or twice', 'monthly', of 'weekly or more'. The result range from "no reported use," "lower risk," or "higher risk." For the lower and higher risk categories the intervention provides guidance for developing an action plan for each response category.

Secondary Outcomes

  • Coping based on the Brief COPE(baseline, 2, 4, 6 months)
  • Family Functioning based on the Inventory of Parent and Peer Attachment(baseline, 2, 4, 6 months)
  • Family Functioning based on the Family Problem Solving Communication Index(baseline, 2, 4, 6 months)
  • Depression(baseline, 2, 4, 6 months)
  • Perceived Stress(baseline, 2, 4, 6 months)
  • Problem Solving(baseline, 2, 4, 6 months)
  • Coping based on the Coping Self-Efficacy Scale(baseline, 2, 4, 6 months)
  • Social support(baseline, 2, 4, 6 months)
  • Stressful Life Events(baseline, 2, 4, 6 months)

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