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临床试验/NCT06274424
NCT06274424已完成不适用

Association Between Hair Cortisol and Symptoms in Children With Psychopathology During CBT

Helsinki University Central Hospital0 个研究点目标入组 100 人开始时间: 2016年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
主要终点
Hair Cortisol Concentration

研究概览

简要总结

This study aims to examine the relationship between hair cortisol concentration and behavior and sleep disturbance symptoms in children with psychiatric disorders. It also investigates potential changes in hair cortisol and symptomatology after group-based cognitive behavior therapy. Furthermore, the study explores the effects of any alterations in hair cortisol concentration levels on potential behavior and sleep disturbance symptom change over the course of the study.

研究设计

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

入排标准

年龄范围
6 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • symptoms of anxiety or depression
  • deficiencies in emotional and behavioral skills impairing functioning
  • sufficient social and cognitive skills to participate in group work.

排除标准

  • excessive physical aggression
  • excessive physical restlessness
  • severity of psychiatric symptoms requiring individual psychotherapy (e.g., acute suicidality).

结局指标

主要结局

Hair Cortisol Concentration

时间窗: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up

Level of hair cortisol concentration measured from hair samples

Parent-rated sleep disturbance symptoms

时间窗: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up

Sleep Disturbance Scale for Children (SDSC). A cutoff score of 39 and above has been suggested to identify children with sleep disturbance.

Parent- and teacher rated internalizing and externalizing symptoms

时间窗: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up

The Achenbach System of Empirically Based Assessment (ASEBA). Scores below 60 reflect the normal range, scores from 60 to 63 the borderline range, and scores above 63 the clinical range

Child-rated internalizing symptoms

时间窗: Before and after the group cognitive behavioral intervention (duration from pre-GCBT to post-GCBT circa 4.7 months), and at a 7-month follow-up

The Spence Children´s Anxiety Scale. A total score of 60 or higher is indicative of elevated anxiety.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarianna Barron-Linnankoski

Principal Investigator

Helsinki University Central Hospital

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