Development and Testing of Adolescent Twelve-Step Facilitation

• ClinicalTrials.gov Identifier: NCT01449981
• Recruitment Status: Completed
• First Posted: October 10, 2011
• Last Update Posted: September 13, 2016
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): John F. Kelly, Massachusetts General Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alcohol Abuse; Alcohol Dependence; Drug Abuse; Drug Dependence	Behavioral: Integrated Twelve-Step Facilitation; Behavioral: Cognitive Behavioral Therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Development and Testing of Adolescent Twelve-Step Facilitation
• Study Start Date: October 2011
• Actual Primary Completion Date: March 2015
• Actual Study Completion Date: January 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Integrated Twelve-Step Facilitation	Behavioral: Integrated Twelve-Step Facilitation; 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 Name: iTSF
Experimental: Cognitive Behavioral Therapy	Behavioral: Cognitive Behavioral Therapy; The CBT condition will include review of progress, coping skills, group exercises, real life practice, and emotions/mood management.; Other Name: CBT

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Treatment Acceptability [ Time Frame: Up to 3 months ]
   Participants will also complete weekly treatment feedback measures to inform the treatment manual.

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

Center for Addiction Medicine 60 Staniford Street

Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

• Principal Investigator: John F. Kelly, Ph.D.; Massachusetts General Hospital

More Information

• Responsible Party: John F. Kelly, Associate Director MGH Center for Addiction Medicine, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01449981
• Other Study ID Numbers: NIAAA R01AA019664
• First Posted: October 10, 2011
• Last Update Posted: September 13, 2016
• Last Verified: September 2016

Keywords provided by John F. Kelly, Massachusetts General Hospital:

Adolescents; Alcohol Abuse; Alcohol Dependence; Drug Abuse; Drug Dependence; Substance Use Disorder; Alcoholics Anonymous; Motivational Enhancement Therapy; Cognitive Behavioral Therapy

Additional relevant MeSH terms:

Alcoholism; Substance-Related Disorders; Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders