Development and Testing of Adolescent Twelve-Step Facilitation

Not Applicable

Completed

• Conditions: Alcohol Dependence; Drug Dependence; Alcohol Abuse; Drug Abuse
• Interventions: Behavioral: Cognitive Behavioral Therapy; Behavioral: Integrated Twelve-Step Facilitation

• Registration Number: NCT01449981
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This study is the first to develop and test in a randomized experimental design the efficacy of an integrated 12-step facilitation intervention tailored for young people. In the first phase of the study, the investigators are developing and revising a preliminary manual for the two sessions individually-delivered Motivational Enhancement Therapy (MET) component and subsequent 8 session group-delivered Cognitive-Behavioral Therapy (CBT) component which will integrate Twelve-step Facilitation (TSF). Forty adolescents each will complete the preliminary integrated TSF protocol. In the second phase of the study, the investigators will compare integrated TSF (iTSF) to standard treatment (MET/CBT) in a randomized experimental design for adolescent substance use disorder with 60 adolescents. As a result, the investigators will examine potential mechanisms that may underlie the efficacy of iTSF in improving alcohol and other drug use outcomes. The investigators will test group differences on potential mechanisms of change (e.g., Alcoholics Anonymous/Narcotics Anonymous attendance and involvement) and whether these variables are associated with substance use outcomes.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-07
• Study First Posted: 2011-10-10
• Primary Completion: 2015-03
• Study Completion: 2016-01
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Young people between the ages of 14 and 21 that meet criteria for alcohol or other drug abuse or dependence.

Exclusion Criteria

Youth

• with an active psychotic disorders
• who are in another substance use disorder (SUD) treatment program or receiving SUD related psychotherapy that could conflict with our treatment
• with a history of severe or complicated withdrawal (e.g., alcohol seizure history)
• who may be using alcohol/drugs prior to study entry at levels likely to result in severe withdrawal complications, in the absence of any history
• taking addiction treatment medications (e.g., Buprenorphine)
• who cannot speak English because the treatment and assessment instruments will be conducted in English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy	Cognitive Behavioral Therapy	-
Integrated Twelve-Step Facilitation	Integrated Twelve-Step Facilitation	-

Primary Outcome Measures

Name	Time	Method
Percent Days Abstinent (PDA)	Up to 9 months	Given the goals of both treatments will be abstinence, the main outcome analyses and effect size estimates will be based upon biochemically verified 90 day point-prevalence of PDA. These will be captured using Form-90 (Miller \& Del Boca, 1994) which will be used to examine substance use (including number of days used and first and last dates of use within the time period), as well as other treatment experiences in the past 90 days.

Secondary Outcome Measures

Name	Time	Method
Treatment Acceptability	Up to 3 months	Participants will also complete weekly treatment feedback measures to inform the treatment manual.

Trial Locations

Locations (1)

Center for Addiction Medicine 60 Staniford Street; 🇺🇸 Boston, Massachusetts, United States