NCT03493243已完成不适用
AVAL Cohort Study First Step, Observational Study, After One Year
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
- 2
- 主要终点
- PTSD
研究概览
简要总结
- Context: Since March 2012, several terrorist attacks have been perpetrated in France (Toulouse, Montauban, Paris, Nice ...). In March 2017, 53 french teenagers were victims in a terrorist attack in London (Westminster Bridge).
- Main goal = to estimate the psycho-traumatic impact and to describe cares and management of high school students, victims of the terrorist attack in London on 2017, March the 22nd.
- 3 secondary objectives: 1) Clinical (occurrence of Post Traumatic Stress Disorders or other disorders); 2) Epidemiological (risk factors for developing disorders, avoiding care); 3) Preventive and therapeutic.
详细描述
Inclusion criterion: 53 teenagers of Saint-Joseph high school (Concarneau, France) directly exposed to the terrorist attack.
Methodology: self questionnaires and heterogenous questionnaires; descriptive statistics (means +/- standard deviations; search for a significant difference according to traumatic symptomatology)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 20 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •53 teenagers, from Concarneau (France) high school, directly exposed from London terrorist attack (22.03.2017).
排除标准
- •All persons not directly exposed;
- •Relatives of teenagers;
- •3 physically injured teenagers.
结局指标
主要结局
PTSD
时间窗: One year after the terrorist attack (Day 1)
Post Traumatic Stress Disorder (Self-Questionnaire :Posttraumatic stress disorder checklist 5 )
次要结局
- Preventive and therapeutic(One year after the terrorist attack (Day 1))
- Clinical (occurence of Post Traumatic Stress Disorders or other disorders)(One year after the terrorist attack (Day 1))
- Epidemiological (risk factors for developing disorders, avoiding care);(One year after the terrorist attack (Day 1))
研究者
COULON Nathalie
medical doctor (psychiatrist for children and teenagers), principal Investigator
University Hospital, Brest
研究点 (2)
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