Development and Testing of Adolescent Twelve-Step Facilitation
1 other identifier
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 4, 2011
CompletedFirst Posted
Study publicly available on registry
October 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedSeptember 13, 2016
September 1, 2016
3.4 years
October 4, 2011
September 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Days Abstinent (PDA)
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.
Up to 9 months
Secondary Outcomes (1)
Treatment Acceptability
Up to 3 months
Study Arms (2)
Integrated Twelve-Step Facilitation
EXPERIMENTALCognitive Behavioral Therapy
EXPERIMENTALInterventions
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.
The CBT condition will include review of progress, coping skills, group exercises, real life practice, and emotions/mood management.
Eligibility Criteria
You may qualify if:
- Young people between the ages of 14 and 21 that meet criteria for alcohol or other drug abuse or dependence.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Addiction Medicine 60 Staniford Street
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John F. Kelly, Ph.D.
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Director MGH Center for Addiction Medicine
Study Record Dates
First Submitted
October 4, 2011
First Posted
October 10, 2011
Study Start
October 1, 2011
Primary Completion
March 1, 2015
Study Completion
January 1, 2016
Last Updated
September 13, 2016
Record last verified: 2016-09