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Development and Testing of Adolescent Twelve-Step Facilitation

Development and Testing of Adolescent Twelve-Step Facilitation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01449981
Enrollment
59
Registered
2011-10-10
Start date
2011-10-31
Completion date
2016-01-31
Last updated
2016-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALIntegrated 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.

BEHAVIORALCognitive Behavioral Therapy

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

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 21 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percent Days Abstinent (PDA)Up to 9 monthsGiven 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

MeasureTime frameDescription
Treatment AcceptabilityUp to 3 monthsParticipants will also complete weekly treatment feedback measures to inform the treatment manual.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026