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