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Development and Testing of Adolescent Twelve-Step Facilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01449981
Recruitment Status : Completed
First Posted : October 10, 2011
Last Update Posted : September 13, 2016
Information provided by (Responsible Party):
John F. Kelly, 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.

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

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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

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

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.

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449981

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United States, Massachusetts
Center for Addiction Medicine 60 Staniford Street
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: John F. Kelly, Ph.D. Massachusetts General Hospital
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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    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Keywords provided by John F. Kelly, Massachusetts General Hospital:
Alcohol Abuse
Alcohol Dependence
Drug Abuse
Drug Dependence
Substance Use Disorder
Alcoholics Anonymous
Motivational Enhancement Therapy
Cognitive Behavioral Therapy
Additional relevant MeSH terms:
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Substance-Related Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders