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临床试验/NCT05473962
NCT05473962已完成不适用

Mid-Term Follow-up Assessment After Exposure to Natural Disaster

Fondation Lenval1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年10月12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
55
试验地点
1
主要终点
diagnostic criteria for post-traumatic stress disorder

研究概览

简要总结

The present study proposes to carry out an evaluation of the children of adolescents who were seen by the teams of the Cellules d'Urgence Médico-Psychologique (CUMP) following the Alex storm in October 2020. A clinical child psychiatric and psychological evaluation will be carried out, with collection of socio-demographic data

详细描述

Description: Assessment 24 months after exposure to a natural disaster of the clinical condition of children and adolescents cared for by medical-psychological emergency teams (CUMP) by measuring the frequency of clinical disorders and the intensity of symptoms and by comparing their clinical condition to that assessed immediately after exposure.

  • Primary endpoint:

Semi-structured interview based on the Clinician-Administered PTSD scale for DSM-5 Child/Adolescent -CAPS-CA-5. This instrument allows for the assessment and quantification of symptoms related to post-traumatic stress. This instrument is validated in English, and a French translation was carried out by the investigators (translation/back-translation method). The instrument uses the DSM-5 diagnostic criteria for post-traumatic stress disorder (PTSD).

  • Secondary endpoints:
  • The intensity of the symptoms of this PTSD will be assessed by the Young Child PTSD checklist (YCPC) (Scheeringa, 2013; translation of the French version: Thümmler et al., 2017) for young children under the age of 7. For children over 7 years of age, it will be assessed by the Child PTSD checklist, child version (CPC) (Scheeringa, 2014; translation and validation of the French version: Gindt et al., 2020).
  • Patient Health Questionnaire 13 items (PQH13). This simple and quick to use instrument allows a systematic assessment of somatization in children. This questionnaire will be offered to parents of children under 7 years of age as a hetero-assessment and directly to children over 7 years of age as a selfassessment.
  • Parental Stress Index - Short Form (PSI-SF): Short version of the Parental Stress Index. The instrument will be offered to parents of study participants in self-report. It evaluates the magnitude of stress in the parent-child system.

Interventions :

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 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Child and/or young adult aged under 18 at the time of exposure having been assessed by the CUMPS teams during the "ALEX Storm" interventions of October 2020
  • Affiliated to a social security scheme
  • Children whose parents have accepted participation in the study and/or young adults who have accepted participation in the study (collection of non-objection

排除标准

  • Children and/or young adults with a severe somatic and/or psychiatric disorder that makes assessment impossible or may alter emotional regulation behavior.
  • Non-participation in a parallel study that could modify emotional regulation behavior

结局指标

主要结局

diagnostic criteria for post-traumatic stress disorder

时间窗: at inclusion

Semi-structured interview based on the Clinician-Administered PTSD scale for DSM-5 Child/Adolescent -CAPS-CA-5. This instrument allows for the This instrument is validated in English, and a French translation was carried out by the investigators (translation/back-translation method). The instrument uses the DSM-5 diagnostic criteria for post-traumatic stress disorder (PTSD). This tool as 517 items. This scale doesn't work on numerical values (there is no min, max or cut scores), this scale makes it possible to confirm or invalidate the presence of symptoms necessary for establishing diagnoses on Diagnosis and Statistical Manual of Mental Disorders (DSMV) criteria

次要结局

  • intensity of the symptoms(at inclusion)
  • assessment of somatization(at inclusion)
  • Parental Stress(at inclusion)

研究者

发起方
Fondation Lenval
申办方类型
Other
责任方
Sponsor

研究点 (1)

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