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临床试验/NCT01825694
NCT01825694已完成不适用

An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2013年4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
117
试验地点
2
主要终点
Urine Toxicology Screen (UTS)

研究概览

简要总结

This study plans to develop an integrated treatment for comorbid post-traumatic stress disorder (PTSD) and substance abuse (SA) in adolescents. The investigators aim to develop a treatment approach that is community-friendly, well-tolerated, and deliverable by substance abuse counselors (SAC) in outpatient settings. The proposed Trauma-Focused Substance Abuse Treatment (TFSAT) aims to reduce PTSD symptoms and substance use and build coping skills. The investigators propose to adapt an evidence-based trauma program, Cognitive-Behavioral Intervention for Trauma in Schools (CBITS), for adolescent substance abusers (ASAbusers); to assess the acceptability and feasibility of the integrated approach; and to pilot test the new program against standard care.

The investigators hypothesize that the intervention group, compared to the control group, will reduce substance use and symptoms for traumatic stress.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Between ages of 13 & 19;
  • meeting DSM IV criteria for substance abuse/dependence and PTSD;
  • previously enrolled at recruitment site for at least 2 weeks;
  • parent/guardian provides permission for minors to participate.

排除标准

  • Not within the specified age range;
  • presence of organic brain damage;
  • inability to understand enrollment forms (e.g. Informed Assent/Consent Form)
  • Inclusion Criteria: Parents/Guardians
  • Age 18 or above;
  • parents/guardians of youth who meets inclusion criteria.
  • Exclusion Criteria: Parents/Guardians
  • presence of organic brain damage.

结局指标

主要结局

Urine Toxicology Screen (UTS)

时间窗: Participants will be followed for an expected average of 12 weeks.

Urine samples will be collected twice per week at the treatment site to ensure validity of self-reports.

Child PTSD Symptom Scale (CPSS)

时间窗: Change from Baseline in Child PTSD Symptom Scale at 8 weeks and change from Baseline in Child PTSD Symptom Scale at 12 weeks.

The CPSS will assess for severity of traumatic stress symptoms.

Timeline Follow-back (TFLB) Assessment of Substance Use

时间窗: Participants will be followed for an expected average of 12 weeks.

The TLFB uses a blank calendar form and a series of questions to cue recall of alcohol and drug (AOD) use. The investigators will use the TLFB interview technique to assess AOD use weekly.

次要结局

  • Child Post-Trauma Attitudes Scale (C-PTAS)(Baseline & 8 weeks & 3 months)
  • Strengths & Difficulties Questionnaire (SDQ)(Baseline & 8 weeks & 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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