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临床试验/NCT01545505
NCT01545505已完成不适用

Early Diagnosis of Risk of Post-Traumatic Stress Disorder (PTSD) Relapse in Children and Their Families

Centre Hospitalier Universitaire de Nice8 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
8
主要终点
Attentional score

研究概览

简要总结

Relapse of post-traumatic stress disorder (PTSD) remains challenging. In addition, factors predicting PTSD relapse are still unknown. The aim of this study is to examine whether clinical and neuropsychological changes (e.g., attentional bias toward aversive cues) that characterized PTSD can be observed in people with past PTSD (children and their families) and whether these persistent changes are predictive of PTSD relapse.

详细描述

One of the great challenges in Psychotraumatology is the high risk (20-40%) of post-traumatic stress disorder (PTSD) relapse, which markers remain understudied. Identification of these markers is of particular interest for the development of strategies to prevent relapse. Based on clinical and experimental data, it appears that (i) the so-called residual clinical symptoms (such as sleep disturbance, irritability) and (ii) the neuropsychological dysfunctions (cognitive difficulties), persisting after remission, may constitute markers of PTSD relapse. Moreover, all of these potential markers have also been linked with dysfunctions, persisting or reoccurring, in the prefrontal cortex after remission.

The main objective of this study is to identify these clinical and neuropsychological markers of PTSD relapse in children and their families. The secondary objective is to demonstrate the link between prefrontal dysfunctions and relapse.

This longitudinal study will include 4 experimental groups:

  • 30 children with PTSD
  • 30 children with past PTSD (children in remission)
  • 30 parents of children with PTSD
  • 30 parents of children with past PTSD The first visit is planned during the symptomatic phase (T0). The second visit (T1) is planned at the end of the symptomatic phase (or 6 months later T0). The last visit is planned 3-months after T1.

The psychological assessment will include:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • For children
  • Inclusion Criteria:
  • Children (9/18 years)
  • Patients who have lived a traumatic event (physical assault and road accident) and who have a PTSD.
  • French speaker.
  • Participants must sign the informed consent and they must be affiliated to the social insurance.

排除标准

  • Children who have a neurological pathology.
  • Children who have brain damage or brain-injured
  • Subject having participated in a biomedical research in three months preceding the inclusion

研究组 & 干预措施

In remission phase of PTSD

Other

Patients having suffered from PTSD in the past and in remission od PTSD and their parents

干预措施: Neuropsychological assessment (Behavioral)

Activ PTSD

Other

patients suffering from PTSD (Post-traumatic Stress Disorder) and their parents

干预措施: Neuropsychological assessment (Behavioral)

结局指标

主要结局

Attentional score

时间窗: baseline at the first visit (T0), at 6 months, at 9 months

Go-No/Go and visual search tests

次要结局

  • memory (Grober and Buschke)(baseline at the first visit (T0), at 6 months, at 9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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