Development and Testing of Adolescent Twelve-Step Facilitation
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|ClinicalTrials.gov Identifier: NCT01449981|
Recruitment Status : Completed
First Posted : October 10, 2011
Last Update Posted : September 13, 2016
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|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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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
- 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.
- Treatment Acceptability [ Time Frame: Up to 3 months ]Participants will also complete weekly treatment feedback measures to inform the treatment manual.
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|Ages Eligible for Study:||14 Years to 21 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
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
|United States, Massachusetts|
|Center for Addiction Medicine 60 Staniford Street|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||John F. Kelly, Ph.D.||Massachusetts General Hospital|
|Responsible Party:||John F. Kelly, Associate Director MGH Center for Addiction Medicine, Massachusetts General Hospital|
|Other Study ID Numbers:||
|First Posted:||October 10, 2011 Key Record Dates|
|Last Update Posted:||September 13, 2016|
|Last Verified:||September 2016|
Substance Use Disorder
Motivational Enhancement Therapy
Cognitive Behavioral Therapy