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Development and Testing of Adolescent Twelve-Step Facilitation

Primary Purpose

Alcohol Abuse, Alcohol Dependence, Drug Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated Twelve-Step Facilitation
Cognitive Behavioral Therapy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse focused on measuring Adolescents, Alcohol Abuse, Alcohol Dependence, Drug Abuse, Drug Dependence, Substance Use Disorder, Alcoholics Anonymous, Motivational Enhancement Therapy, Cognitive Behavioral Therapy

Eligibility Criteria

14 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Addiction Medicine 60 Staniford Street

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Integrated Twelve-Step Facilitation

Cognitive Behavioral Therapy

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Treatment Acceptability
Participants will also complete weekly treatment feedback measures to inform the treatment manual.

Full Information

First Posted
October 4, 2011
Last Updated
September 12, 2016
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01449981
Brief Title
Development and Testing of Adolescent Twelve-Step Facilitation
Official Title
Development and Testing of Adolescent Twelve-Step Facilitation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Alcohol Dependence, Drug Abuse, Drug Dependence
Keywords
Adolescents, Alcohol Abuse, Alcohol Dependence, Drug Abuse, Drug Dependence, Substance Use Disorder, Alcoholics Anonymous, Motivational Enhancement Therapy, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Integrated Twelve-Step Facilitation
Arm Type
Experimental
Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Integrated Twelve-Step Facilitation
Other Intervention Name(s)
iTSF
Intervention Description
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
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT
Intervention Description
The CBT condition will include review of progress, coping skills, group exercises, real life practice, and emotions/mood management.
Primary Outcome Measure Information:
Title
Percent Days Abstinent (PDA)
Description
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.
Time Frame
Up to 9 months
Secondary Outcome Measure Information:
Title
Treatment Acceptability
Description
Participants will also complete weekly treatment feedback measures to inform the treatment manual.
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John F. Kelly, Ph.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Addiction Medicine 60 Staniford Street
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Development and Testing of Adolescent Twelve-Step Facilitation

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