Development and Testing of Adolescent Twelve-Step Facilitation

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.

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Key information

Conditions

Alcohol Abuse Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Drug Abuse Drug Dependence Mental Disorders Substance-Related Disorders

Age range

14 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Addiction Medicine 60 Staniford Street

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrated Twelve-Step Facilitation

Behavioral

The iTSF condition will include review of treatment goals and overall review of progress, coping skills, real life practices, emotions/mood management, how to make changes in one's social network and discussions about how 12-step meetings can be helpful in one's recovery efforts. In addition, speakers from 12-step fellowships such as Alcoholics Anonymous (AA) and Narcotics Anonymous (NA) will be invited to share their experiences and discuss myths and facts related to attendance at 12-step meetings as well as answer any questions participants have about these fellowships.

Other names: iTSF

Cognitive behavioral therapy

Behavioral

The CBT condition will include review of progress, coping skills, group exercises, real life practice, and emotions/mood management.

Other names: CBT

Primary outcomes

Percent Days Abstinent (PDA)

Time frame: 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 outcomes

Treatment Acceptability

Time frame: Up to 3 months

Participants will also complete weekly treatment feedback measures to inform the treatment manual.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2016
First posted: Oct 10, 2011
Registry last updated: Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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