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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
Sponsor:
Information provided by (Responsible Party):
John F. Kelly, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE October 4, 2011
First Posted Date  ICMJE October 10, 2011
Last Update Posted Date September 13, 2016
Study Start Date  ICMJE October 2011
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2011)
Percent Days Abstinent (PDA) [ Time Frame: Up to 6 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2011)
Treatment Acceptability [ Time Frame: Up to 3 months ]
Participants will also complete weekly treatment feedback measures to inform the treatment manual.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Development and Testing of Adolescent Twelve-Step Facilitation
Official Title  ICMJE Development and Testing of Adolescent Twelve-Step Facilitation
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Alcohol Abuse
  • Alcohol Dependence
  • Drug Abuse
  • Drug Dependence
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Integrated Twelve-Step Facilitation
    Intervention: Behavioral: Integrated Twelve-Step Facilitation
  • Experimental: Cognitive Behavioral Therapy
    Intervention: Behavioral: Cognitive Behavioral Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2016)
59
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2011)
30
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01449981
Other Study ID Numbers  ICMJE NIAAA R01AA019664
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party John F. Kelly, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John F. Kelly, Ph.D. Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP