跳至主要内容
临床试验/NCT04363112
NCT04363112终止不适用

Association Between a Biological Pattern of Dysregulation of the HPA Axis and Mental Disorders in Children Exposed to Early Life Stress

University Hospital, Brest2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2022年3月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
2
主要终点
Mini Kid II : Mini International Neuropsychiatric Interview

研究概览

简要总结

The purpose of this study is to demonstrate an association between a biological pattern of dysregulation of the HPA axis and mental disorders in children exposed to early life stress.

详细描述

The purpose of this study is to demonstrate an association between a biological pattern of dysregulation of the HPA axis and mental disorders in children exposed to early life stress.

Cortisol secretion lead to define two groups : pathologic versus normal cortisol secretion.

Mental disorders is evaluate with Mini-Kids II (a mental health questionary) and lead to define two groups : mental disorders versus no mental disorders

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
8 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged 8 to over 10 years
  • To be entrust to ASE of Finistère in stable environment (the same place of residence since 6 months or more)
  • French speaking
  • Oral consent by children
  • Informed and signed consent by tenured of parent authority

排除标准

  • Don't want to participate
  • To have chronic neurologic or endocrinal pathology or don't have access to verbal language.

研究组 & 干预措施

study with just one arm

Other

All of participants are in this arm. Mini Kid II and CBCL score are administered between day 3 and 7. Moreover, salivary test will be remove to evaluate cortisol secretion, 4 time per day during 2 consecutive days.

Psychologic aftercare will be propose if children have psychologic troubles (results of Mini Kid II)

干预措施: Mini Kid II (Behavioral)

结局指标

主要结局

Mini Kid II : Mini International Neuropsychiatric Interview

时间窗: Day 10 to the study

Standardized questionary administered by a physician. There are 30 pages with 17 subjects like depression, maniac trouble, panic trouble, etc.

次要结局

  • BRIEF : Behavrioral Rating Inventory of Executive Function(Day 10 to the study)
  • CBCL score : Child Behaviour Check List(Day 10 to the study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验