Development and Testing of Adolescent Twelve-Step Facilitation

Alcohol Dependence Clinical Trial

Official title:

Development and Testing of Adolescent Twelve-Step Facilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449981
• Other study ID #: NIAAA R01AA019664
• Status: Completed
• Phase: N/A
• First received: October 4, 2011
• Last updated: September 12, 2016
• Start date: October 2011
• Est. completion date: January 2016

Study information

• Verified date: September 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 21 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Dependence
• Alcoholism
• Drug Abuse
• Drug Dependence
• Substance-Related Disorders

Intervention

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.
• Cognitive Behavioral Therapy
The CBT condition will include review of progress, coping skills, group exercises, real life practice, and emotions/mood management.

Locations

Country	Name	City	State
United States	Center for Addiction Medicine 60 Staniford Street	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Treatment Acceptability	Participants will also complete weekly treatment feedback measures to inform the treatment manual.	Up to 3 months	No