Development and Testing of Adolescent Twelve-Step Facilitation

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
John F. Kelly, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01449981
First received: October 4, 2011
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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 Intervention
Alcohol Abuse
Alcohol Dependence
Drug Abuse
Drug Dependence
Behavioral: Integrated Twelve-Step Facilitation
Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Development and Testing of Adolescent Twelve-Step Facilitation

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Percent Days Abstinent (PDA) [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    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:
  • Treatment Acceptability [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    Participants will also complete weekly treatment feedback measures to inform the treatment manual.


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449981

Contacts
Contact: Veselina Hristova, B.A. 617-643-5927 vhristova@partners.org
Contact: Julie Cristello, B.A. 617-643-4690 jcristello@partners.org

Locations
United States, Massachusetts
Center for Addiction Medicine 60 Staniford Street Recruiting
Boston, Massachusetts, United States, 02114
Contact: Veselina Hristova, B.A.    617-643-5927    vhristova@partners.org   
Contact: Julie Cristello, B.A.    617-643-4690    jcristello@partners.org   
Principal Investigator: John F. Kelly, Ph.D.         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: John F. Kelly, Ph.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: John F. Kelly, Associate Director MGH Center for Addiction Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01449981     History of Changes
Other Study ID Numbers: NIAAA R01AA019664
Study First Received: October 4, 2011
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on October 23, 2014