Development and Testing of Adolescent Twelve-Step Facilitation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Percent Days Abstinent (PDA)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Young people between the ages of 14 and 21 that meet criteria for alcohol or other drug abuse or dependence.
排除标准
- •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
结局指标
主要结局
Percent Days Abstinent (PDA)
时间窗: 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.
次要结局
- Treatment Acceptability(Up to 3 months)
研究者
John F. Kelly
Associate Director MGH Center for Addiction Medicine
Massachusetts General Hospital