跳至主要内容
临床试验/NCT00614068
NCT00614068已完成不适用

Creating a Collaborative Field Research Organization

Icahn School of Medicine at Mount Sinai8 个研究点 分布在 1 个国家目标入组 40 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
40
试验地点
8
主要终点
University of California Los Angeles- Post-Traumatic Stress Disorder (UCLA-PTSD) Reaction Index

研究概览

简要总结

This study will compare the effectiveness of trauma-focused cognitive behavioral therapy versus standard care in treating children with post-traumatic stress disorder.

详细描述

Each year approximately 5 million children in the United States are exposed to some form of traumatic event, and nearly 40% of these children will go on to develop post-traumatic stress disorder (PTSD). There are a number of traumatic events that have been shown to cause PTSD in children, including natural disaster, physical or sexual abuse, loss of a loved one, and witnessing an act of violence. Children with PTSD may experience persistent generalized fear and anxiety, recurrent nightmares, mood swings, withdrawal, and depression. If left untreated, PTSD can cause serious distress for those affected, resulting in emotional, academic, and social problems. Trauma-focused cognitive behavioral therapy (TF-CBT), a form of psychotherapy that focuses on trauma, may be the most effective means of improving PTSD screening and treatment in community-based mental health services. Although TF-CBT has shown success in treating children with PTSD in the research setting, its use in community clinics remains limited. This study will compare the effectiveness of TF-CBT versus treatment as usual (TAU) in treating children with PTSD in community clinics. The study will also develop a community collaboration between a community mental health agency and an academic institution, both in New York City, to address childhood trauma and PTSD and to enhance research in community clinics.

Participation in this study will last about 3 months. Potential parent and child participants will first undergo initial assessments, which will include interviews and questionnaires concerning symptoms of PTSD. Eligible participants will then be assigned randomly to receive TF-CBT or TAU. Participants in both groups will attend 12 sessions over 3 months. TF-CBT sessions will include trauma-focused treatment and will teach participants behavioral management and coping skills to overcome their PTSD. TAU sessions will include routine community clinic care and will not involve a trauma-focused treatment component. Upon completion of treatment, participants will complete repeat interviews and questionnaires.

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
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Seeking services at Jewish Board of Family and Children's Services outpatient clinics
  • Meets DSM-IV criteria for PTSD
  • Stable on medication for 1 month before study entry
  • English-speaking

排除标准

  • Active suicidality or anyone whose life circumstances might be considered peri-traumatic (e.g., active current abuse)
  • Uncontrolled psychosis
  • Severe mental retardation or severe brain damage
  • Severe language comprehension barriers

结局指标

主要结局

University of California Los Angeles- Post-Traumatic Stress Disorder (UCLA-PTSD) Reaction Index

时间窗: Measured at baseline and Month 3

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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