跳至主要内容
临床试验/NCT07794332
NCT07794332招募中不适用

Evaluation of Post-traumatic and Neurodevelopmental Symptoms in Adolescents Placed in Child Welfare

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Prevalence of post-traumatic stress disorder (PTSD) according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria

研究概览

简要总结

This study aims to characterize emotional dysregulation in complex post-traumatic stress disorder (cPTSD) and to determine the extent to which it can promote the distinction with borderline personality disorder (BPD) and post-traumatic stress disorder (PTSD).

As emotional dysregulation is a dynamic process whose phenomenological manifestations are labile, associated with physiological modifications and modulated by cognitive processing, a multiple methodology associating measurements in a real-life ecological context with measurements performed in the hospital will be preferred.

Overall, this study proposes to capture, for the first time, the clinical manifestations associated with cPTSD from the perspective of emotional dysregulation and its underlying processes

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adolescent aged 12 to 17
  • Entrusted to ASE Bas-Rhin.
  • Fluent in French
  • Affiliated with a social health insurance scheme
  • Agreeing to take part in the study
  • Legal representative of the minor or his/her guardian, or his/her representative from the ASE agreeing to take part in the study.

排除标准

  • Adolescent refusing to participate in the study
  • Legal representative of the minor or his/her guardian, or his/her ASE representative refusing to participate in the study
  • Adolescent with severe developmental delay
  • Adolescent participating in another research study
  • Adolescent deprived of liberty by judicial or administrative decision

结局指标

主要结局

Prevalence of post-traumatic stress disorder (PTSD) according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria

时间窗: From inclusion to the end (6 months)

PTSD will be assessed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria, using the Child Post-Traumatic Checklist (CPC-P). The outcome will be the proportion of participants meeting DSM-5 diagnostic criteria for PTSD.

Prevalence of complex post-traumatic stress disorder (CPTSD) according to International Classification of Diseases, 11th Revision (ICD-11) criteria

时间窗: From inclusion to 6 months

Complex post-traumatic stress disorder (CPTSD) will be assessed according to the International Classification of Diseases, 11th Revision (ICD-11) diagnostic criteria, using the Child and Adolescent Trauma Screen (CATS). The outcome will be the proportion of participants meeting ICD-11 diagnostic criteria for CPTSD.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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