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临床试验/NCT01859000
NCT01859000已完成不适用

Family-Based Drug Services for Young Disaster Victims

University of Miami4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
4
主要终点
Substance use

研究概览

简要总结

This protocol seizes this rare scientific opportunity to test an integrative family based model to address youths' coexisting substance abuse and trauma in the wake of Hurricane Katrina. The study would address a number of gaps in the current evidence base related to understanding and treating comorbid teen drug abuse and trauma that may be initiated or exacerbated in the wake of disasters such as Hurricane Katrina. This study would compare two promising interventions for youth with comorbid trauma and substance abuse, family-based treatment and group Cognitive Behavioral Therapy (CBT), potentially yielding new and vital information about effective treatment for substance abusing youth following traumatic events.

详细描述

This study is a 2 (treatments) by 5 (time points), repeated measures intent-to-treat randomized control design with multiple dependent variables. The sample includes a total of 150 ethnically diverse adolescents who are clinically referred for substance abuse treatment throughout St. Charles Parish, a New Orleans area parish that was heavily impacted by Hurricane Katrina. The parish has high rates of teen substance abuse as documented in school surveys (State of Louisiana Office for Addictive Disorders, 2002, 2004). Eligible youth, who meet American Society of Addiction Medicine (ASAM) criteria for outpatient substance abuse treatment and report trauma symptoms related to Hurricane Katrina, will be randomized to a family-based treatment (MDFT) or group CBT. Both treatments will be delivered approximately twice weekly over 4 months. Assessments of youth and family functioning across several domains will be conducted at intake, 2, 4, 6, and 12 month follow-up. Measuring multiple domains at several assessment points within and following treatment (Brown, 2004) will enable investigators to examine trajectories of change as well as mediators and moderators of treatment effects.

The study has four aims:

Aim 1: To explore links between hurricane-related stress and trauma and youths' substance abuse.

Hypothesis 1: Severity of youths' substance use at intake to treatment will be predicted by level of exposure to Hurricane Katrina, stressful life events following Katrina, trauma symptoms, and coping.

Aim 2: To investigate in a community based randomized control trial the effectiveness of a family-based intervention (MDFT) vs. group CBT for teen substance abusers impacted by Hurricane Katrina.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Between ages of 13 and 17
  • Meet ASAM criteria for outpatient substance abuse treatment
  • At least mild trauma symptoms on PTSD-Reaction Index
  • Not receiving any other behavioral treatment
  • Parent/guardian willing to participate in the study/treatment
  • Parent informed consent and youth informed assent to participate in the study

排除标准

  • Mental retardation or pervasive developmental disorders
  • Psychotic disorder as indicated by record review
  • current suicidality as indicated by verbalization of ideation + intent + plan in interview

结局指标

主要结局

Substance use

时间窗: Intake through the 12-month follow-up

The Timeline Follow-Back Method, Personal Experiences Inventory and Urinalyses will be used to measure substance use.

次要结局

  • Delinquency(One year prior to intake through the 12-month follow-up)
  • Trauma Symptoms(Screening through the 12-month follow-up)
  • School Problems(One year prior to intake through the 12-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cynthia Rowe

Research Associate Professor

University of Miami

研究点 (4)

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