Effect of COVID-19 Related COntainment in ChildreN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 703
- 试验地点
- 1
- 主要终点
- Signs of post traumatic stress disorder
研究概览
简要总结
The current pandemic situation (SRAS COV2) is an unprecedented event and a source of stress potentially aggravated by containment. The Child Revised Impact Event Scale (CRIES-13) was evaluated in children 8 years or older in survivors of traumatic events, flood, stay in intensive care, or war (Bosnia). In this study CRIES-13 will be used to determine the prevalence of precursor signs of post-traumatic stress in children aged 8 to 15 confined between March 17, 2020 and May 2020
详细描述
Parents of children aged 8 to 15 will be approached from different levels / places of selection / recruitment. A clinical researcher of pediatric clinical investigation center will collect the responses.
If one of the holders of parental authority and the child agree to participate, an information notice will be sent to them, then they will be contacted by telephone by a clinical research assistant to answer the questionnaire.
In large families, the CRIES-13 of the holder of parental authority and of the child will be applied for each of them whose age corresponds to the inclusion criteria.
The duration of the study / participant call and effective response to the questionnaire by the holder of parental authority and the child will takes a maximum of 20 minutes.
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
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Binomial of child (aged between 8 and 15) and one of its holders of parental authority agreeing to participate
排除标准
- •children aged under 8 and over 15
- •children whose parents are opposed
- •children refusing to participate
- •holders of minor parental authority
结局指标
主要结局
Signs of post traumatic stress disorder
时间窗: 1 month
Using a simple score (Child Revised Impact of Event Scale (CRIES-13)), determine the prevalence of precursor signs of post-traumatic stress in children aged 8 to 15 confined between March 17, 2020 and May 2020
次要结局
未报告次要终点