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临床试验/NCT01509872
NCT01509872已完成不适用

An RCT Comparing Trauma-Focused Cognitive Behavioral Therapy (a Specific Psychological Intervention) and A Child Friendly Space (a Non-trauma Focused Psychosocial Intervention) in Reducing Psychological Distress Among War-affected Children

Queen's University, Belfast1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index

研究概览

简要总结

The investigators are interested in knowing whether a group-based, trauma-focused intervention (Trauma Focused Cognitive Behavioral Therapy) is superior to a more general, non trauma-focused, psychosocial intervention (Child Friendly Spaces) in reducing post-traumatic stress, depression and anxiety and conduct problems and increasing pro-social behavior among war-affected children in the Democratic Republic of Congo.

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
Double (Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • under 18 years of age,
  • witness to a violent event involving a real or perceived direct threat to life,
  • ability to attend a 3-week intervention

排除标准

  • psychosis,
  • mental retardation,
  • inability to understand Swahili,
  • severe emotional & behavioral problems that made group participation impossible

研究组 & 干预措施

Trauma-Focused Cognitive Behavioral Therapy

Experimental

Trauma-Focused Cognitive Behaviour Therapy (Cohen, Mannarino, Deblinger, 2006; Smith and Saunders, 2005) is a child-friendly, manualised psychological intervention for children who experience nightmares, flashbacks, anxiety, anger, social isolation, poor concentration or self-blame after experiencing or witnessing a violent and terrifying life event (e.g. rape, murder, abduction etc). This intervention was culturally modified for use with war-affected children.

干预措施: Trauma Focused Cognitive Behavioral Therapy (Behavioral)

A Child Friendly Space

Active Comparator

A Child Friendly Space is a psychosocial intervention combining creative (e.g. art), imaginative (e.g. drama), physical (e.g. football), communicative (e.g. group discussions) and manipulative activities (e.g. story telling). It aids children's natural development by providing a safe place for children to learn, express themselves, grow and develop, supported by trained animators and peer educators.

干预措施: Child Friendly Space (Behavioral)

结局指标

主要结局

Change in Post-traumatic Stress Symptoms as Measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index

时间窗: baseline, 3 week post-intervention and 6-month follow up

The UCLA PTSD Reaction Index is a self-report questionnaire that measures exposure to traumatic events and assesses post-tramatic stress symptoms in school-age children and adolescents. The Congolese Swahili version used in the study had 22 items and assesses the frequency of occurrence of PTSD symptoms during the past week (rated from 0 = none of the time to 4 = most of the time). The scale ranged from 0 (no symptoms) to 88 (highest score possible). Although no cut-off score was used, the higher the score of the scale the higher the number of PTSD symptoms experienced.

次要结局

  • Change in Pro-Social Behaviors as Measured by the African Youth Psychosocial Assessment Instrument(baseline, 3-week post-intervention, 6-month follow up)
  • Change in Internalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument(baseline, 3 week post-intervention and 6 month follow up)
  • Change in Externalizing Symptoms as Measured by the African Youth Psychosocial Assessment Instrument(baseline, 3-week post-intervention, 6-month follow up)

研究者

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

Paul O'Callaghan

Principal Investigator

Queen's University, Belfast

研究点 (1)

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