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临床试验/NCT02130479
NCT02130479已完成1 期

Testing a Promising Treatment for Youth Substance Abuse in a Community Setting

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2014年4月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
101
试验地点
2
主要终点
Change in youths' delinquent behavior as measured by Juvenile Justice Archival Records and the Self-Report Delinquency Scale

研究概览

简要总结

This study aims to address a serious public health problem (i.e., substance abusing adolescents) by testing the effectiveness of a promising substance abuse treatment implemented in a community-based treatment setting (CM-FAM, a family-based contingency management intervention) in comparison to usual treatment services.

详细描述

The overriding purpose of the randomized trial is to examine the effectiveness of a promising and efficient outpatient treatment of adolescent substance abuse delivered in a community-based treatment setting. Although several evidence-based treatments of adolescent substance abuse are emerging, none have experienced widespread adoption in community settings. Thus, as noted by the Institute of Medicine (1998) more than a decade ago and reiterated more recently, a considerable science-service gap exists in regards to treatment of substance abuse in adolescents and adults.

For the proposed study, 204 adolescents meeting diagnostic criteria for substance abuse or dependence will be randomized to either the Contingency Management-Family Engagement (CM-FAM) or Treatment as Usual (TAU) conditions. A multimethod, multirespondent approach will be used to track clinical outcomes at 3, 6, 9, 12, and 18 months post recruitment. Clinical level outcomes pertain to youth substance use, criminal behavior, mental health functioning, and key mediators of serious antisocial behavior in adolescents (e.g., self-control, parental supervision, association with deviant peers). In addition, the incremental cost of CM-FAM will be determined for use in cost effectiveness analyses.

Aim 1: Over an 18-month post-recruitment follow-up, determine the relative effectiveness of CM-FAM vs. TAU in reducing adolescent participants' substance use, criminal activity (including incarceration), and mental health symptoms; and evaluate the cost effectiveness of CM-FAM in achieving these outcomes.

Aim 2: Examine possible moderators and mediators of intervention effectiveness. Moderator variables will include youth demographic and clinical (e.g., co-occurring disorders) characteristics. Mediator variables will include measures of self-control, parenting, and association with deviant peers - constructs targeted by CM-FAM.

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
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age of 12-17 years
  • Meeting criteria for substance use or abuse.

排除标准

  • 未提供

研究组 & 干预措施

Contingency Management-Family Engagement

Experimental

The Contingency Management-Family Engagement or CM-FAM model integrates behavioral (e.g., drug testing linked with consequences) and cognitive behavioral (e.g., functional analyses of drug use, self-management and drug refusal skills training) strategies based on the Community Reinforcement Approach with effective family engagement strategies used in Multisystemic Therapy.

干预措施: Contingency Management-Family Engagement (Behavioral)

Treatment as Usual

Active Comparator

Standard community-based substance abuse treatment services.

干预措施: Treatment as Usual (Behavioral)

结局指标

主要结局

Change in youths' delinquent behavior as measured by Juvenile Justice Archival Records and the Self-Report Delinquency Scale

时间窗: Youth baseline, 3, 6, 9, 12, & 18 months post-baseline

Change in youths' mental health functioning as measured by the Brief Problem Checklist

时间窗: Youth baseline, 3, 6, 9, 12, & 18 months post-baseline

Change in youths' substance abuse frequency as measured by Urine Drug Screens and the Global Appraisal of Individual Needs Scale

时间窗: Youth baseline, 3, 6, 9, 12, & 18 months post-baseline

次要结局

  • Change in youths' peer relations as measured by the Peer Delinquency and Drug Activities Scales, the Conventional Activities of Peers Scale, and the Bad Friends Scale from the Pittsburgh Youth Study(Youth baseline, 3, 6, 9, 12, & 18 months post-baseline)
  • Change in family functioning as measured by the Caregiver Supervision Scale, the Discipline Scale, and the Communication Form from the Pittsburgh Youth Study(Youth baseline, 3, 6, 9, 12, & 18 months post-baseline)
  • Change in youths' self-control as measured by the Good Behavioral Self-Control and the Poor Behavioral Regulation Scales(Youth baseline, 3, 6, 9, 12, & 18 months post-baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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