Methodology of " CoCo 20 ": a Longitudinal Follow-up Study of the Paediatric Population and Their Families During and After the Coronavirus Pandemic and the Confinement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- diagnosis of possible psychological and psychiatric difficulties at baseline
研究概览
简要总结
In the context of a viral outbreak and of widespread quarantine measures, a significant increase in psychological disorders, such as stress or fear behaviours, had previously been observed. This distress has been described on adults, but no data have been collected yet for paediatric populations.
After a traumatic event, children and adolescents may present several clinical consequences, the most common being Post-Traumatic Stress Disorder (PTSD). Moreover, PTSD in children and adolescents is often associated with comorbid disorders, such Attention Deficit Hyperactivity Disorder, depression, attachment and anxiety disorders, sleep disturbances and behavior problems.
The aim of this study is to present the methodology of "CoCo 20" : is to assess the impact of the pandemic of coronavirus disease 2019 (Covid-19) and of seclusion measures on mental health and on the development of psychological disorders in children in the short to medium term
详细描述
In the context of a viral outbreak and of widespread quarantine measures, a significant increase in psychological disorders, such as stress or fear behaviours, had previously been observed. This distress has been described on adults, but no data have been collected yet for paediatric populations.
After a traumatic event, children and adolescents may present several clinical consequences, the most common being Post-Traumatic Stress Disorder (PTSD). Moreover, PTSD in children and adolescents is often associated with comorbid disorders, such Attention Deficit Hyperactivity Disorder, depression, attachment and anxiety disorders, sleep disturbances and behavior problems.
The aim of this study is to present the methodology of "CoCo 20" : is to assess the impact of the pandemic of coronavirus disease (Covid-19) and of seclusion measures on mental health and on the development of psychological disorders in children in the short to medium term.
The major inclusion criteria are children and adolescents under 18 years of age who have been affected by the Covid 19 pandemic. Three groups were defined: children in group one had a previous history of traumatic events, those in group two had a record of previous psychiatric or psychological disorder with a follow-up treatment and Group three included children without traumatic history nor psychiatric or psychological follow-up treatment. Participants will be assessed at baseline (V0), 1 week after (V1), one month after baseline (V2), one week after the end of the containment (V3) and one month after the end of the containment (V4).
Main analyses comprise analyses of variance and regression analyses of predictors of clinical evolution over time
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
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children affected by the Coronavirus disease 2019 (Covid-19) pandemic;
- •Age between 0 and under 18 at the time of inclusion;
- •Affiliated with a social security scheme;
- •Having a good command of the French language (French);
- •Children whose parents have accepted participation in the study (collection of informed consents).
排除标准
- •Children and/or young adults with a psychotic disorder or autism spectrum disorder;
- •Children and/or young adults with an average intellectual disability (< to 50);
- •Person deprived of liberty by judicial or administrative decision1;
- •Person subject to a period of exclusion for another search.
结局指标
主要结局
diagnosis of possible psychological and psychiatric difficulties at baseline
时间窗: at baseline Day 0
measure of psychological and psychiatric difficulties in connection with the pandemic and confinement. This will allow a rapid implementation of a course of care adapted and specific to the difficulties presented by each child, by Quantitative and qualitative assessments :
次要结局
- follow up of psychological and psychiatric difficulties at V2(at one month after baseline)
- follow up of psychological and psychiatric difficulties at V3(at one week after the end of the containment)
- follow up of psychological and psychiatric difficulties at V4(at one month after the end of the containment)
- impact of traumatic history prior to confinement(at one week after baseline and at one month after the end of the containment)
- impact of other previous psychiatric disorders(at one month after baseline and at one month after the end of the containment)
- parental reaction(at one week after baseline and at one week after the end of the containment)