Development and Testing of Adolescent Twelve-Step Facilitation

NCT ID: NCT01449981

Last Updated: 2016-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2016-01-31

Brief Summary

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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

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Conditions

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Alcohol Abuse Alcohol Dependence Drug Abuse Drug Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Integrated Twelve-Step Facilitation

Group Type EXPERIMENTAL

Integrated Twelve-Step Facilitation

Intervention Type BEHAVIORAL

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

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy

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

Intervention Type BEHAVIORAL

Other Intervention Names

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iTSF CBT

Eligibility Criteria

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Inclusion Criteria

* Young people between the ages of 14 and 21 that meet criteria for alcohol or other drug abuse or dependence.

Exclusion Criteria

* 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
Minimum Eligible Age

14 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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John F. Kelly

Associate Director MGH Center for Addiction Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John F. Kelly, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Center for Addiction Medicine 60 Staniford Street

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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NIAAA R01AA019664

Identifier Type: -

Identifier Source: org_study_id

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