Skip to main content
Clinical Trials/NCT01449981
NCT01449981
Completed
N/A

Development and Testing of Adolescent Twelve-Step Facilitation

Massachusetts General Hospital1 site in 1 country59 target enrollmentOctober 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alcohol Abuse
Sponsor
Massachusetts General Hospital
Enrollment
59
Locations
1
Primary Endpoint
Percent Days Abstinent (PDA)
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
January 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John F. Kelly

Associate Director MGH Center for Addiction Medicine

Massachusetts General Hospital

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

  • 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

Outcomes

Primary Outcomes

Percent Days Abstinent (PDA)

Time Frame: Up to 9 months

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 Outcomes

  • Treatment Acceptability(Up to 3 months)

Study Sites (1)

Loading locations...

Similar Trials