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临床试验/NCT01085370
NCT01085370已完成不适用

Psychological Interventions in Children After Road Traffic Accidents or Burns: a Randomized Controlled Study

University Children's Hospital, Zurich2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2010年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
试验地点
2
主要终点
Clinician administered PTSD Scale for Children/Adolescents (CAPS-CA) and Child Posttraumatic Stress Disorder Semistructured Interview and Observational Scale (PTSDSSI)

研究概览

简要总结

Within a randomized controlled design the effects of a brief early psychological intervention (child, parents) after road traffic accidents or burns shall be examined in a sample of 120 children and adolescents (aged 2 to 16 years). During the first seven days after the accident a screening for the risk of developing a posttraumatic stress disorder is conducted to divide the participants into a "high risk" and a "low risk" group. Participants with a low risk are excluded from the intervention study but reassessed six months after their accident to validate the screening instrument. After a baseline assessment within 14 days after the accident participants of the high risk group are randomly assigned to an intervention group (n = 60) or a control group (n = 60). The latter receive standard medical care. Children of the intervention group are provided with a brief age appropriate two-session intervention that includes a detailed reconstruction of the accident, psychoeducation and discussion of helpful coping strategies. Both the control and the intervention group are reassessed by blind raters at 3 and 6 months after the accident. Assessment of outcome includes measures of posttraumatic stress symptoms, depression, anxiety, behavior, and health-related quality of life.

研究设计

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

入排标准

年龄范围
2 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 2-16 years
  • Glasgow Coma Scale (GCS) > 8
  • German speaking
  • Burn accident or road traffic accident

排除标准

  • Glasgow Coma Scale (GCS) < 9
  • more than 2 weeks in the Pediatric Intensive Care Unit
  • no command of German
  • previous mental retardation

结局指标

主要结局

Clinician administered PTSD Scale for Children/Adolescents (CAPS-CA) and Child Posttraumatic Stress Disorder Semistructured Interview and Observational Scale (PTSDSSI)

时间窗: Baseline, 3 months, 6 months post intervention

次要结局

  • KIDSCREEN-Questionnaire / TAPQOL-Questionnaire (health-related quality of life)(Baseline, 3 months, 6 months post intervention)
  • Child behavior Child Behavior Checklist (CBCL)(Baseline, 3 months, 6 months post intervention)
  • Child Depression Inventory (CDI)(Baseline, 3 months, 6 months post intervention)

研究者

发起方
University Children's Hospital, Zurich
申办方类型
Other
责任方
Sponsor

研究点 (2)

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