Development and Testing of Adolescent Twelve-Step Facilitation
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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 | Phase |
|---|---|---|
|
Alcohol Abuse Alcohol Dependence Drug Abuse Drug Dependence |
Behavioral: Integrated Twelve-Step Facilitation |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Development and Testing of Adolescent Twelve-Step Facilitation |
- Percent Days Abstinent (PDA) [ Time Frame: Up to 6 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.
- 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: | 40 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Integrated Twelve-Step Facilitation |
Behavioral: Integrated Twelve-Step Facilitation
In the initial stage of this project, the manual adaptation stage, we will refine our preliminary manual for iTSF. Information for refining the manual will come from recruitment and treatment of forty adolescents.
Other Name: iTSF
|
Eligibility| Ages Eligible for Study: | 14 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adolescents between the ages of 14 and 19 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| Contact: Veselina Hristova, B.A. | 617-643-5927 | vhristova@partners.org |
| Contact: Julie Cristello, B.A. | 617-643-4690 | jcristello@partners.org |
| 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. | |
| 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: | January 2, 2013 |
| 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 Substance-Related Disorders Alcohol-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 17, 2013