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临床试验/NCT05424900
NCT05424900已完成不适用

An Integrative Intervention for Preventing Children's Emotional Disorders

Oana David1 个研究点 分布在 1 个国家目标入组 294 人开始时间: 2021年5月3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
294
试验地点
1
主要终点
Child emotion regulation

研究概览

简要总结

The general objective of the study is to test an online platform for the prevention of emotional disorders in children aged 8-12 without any clinical symptoms.

详细描述

The general objective of the study is to test an online platform for the prevention of emotional disorders in children aged 8-12 without any clinical symptoms. The game will be used by children and adolescents for a period of four weeks. Pre-test and post-test measurements will be taken.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • children aged 8 to 12 years
  • parental consent provided
  • al least one answer different than never true on the Childhood Trauma Questionnaire - Short Form (CTQ-SF; Bernstein & Fink, 1998; Bernstein et al., 2003), measuring dichotomically the presence of Emotional Neglect, Physical Neglect, Emotional Abuse, Physical Abuse

排除标准

  • intellectual disability or physical limitations precluding the use of the online platform presence of a mental health disorder in the children or their enrolled parent

结局指标

主要结局

Child emotion regulation

时间窗: baseline; pre-intervention (one week before the intervention)

The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001). The 13 items are measured on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilitie

Changes in children emotional regulation

时间窗: post-test, one week after the intervention

The Cognitive Emotion Regulation Questionnaire - Short (Garnefski \& Kraaij, 2006) is an 18-item self-report scale that measures a total of nine different cognitive coping strategies, each addressed by two items.

child emotional simptoms

时间窗: baseline; pre-intervention (one week before the intervention)

SDQ - Strengths and Difficulties Questionnaire "Goodman R, Meltzer H, Bailey V (1998)

Changes in child emotional simptoms

时间窗: post-test, one week after the intervention

SDQ - Strengths and Difficulties Questionnaire, Goodman R, Meltzer H, Bailey V (1998)

Changes in child emotion regulation

时间窗: post-test, one week after the intervention

The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001). The 13 items are measured on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilities.

Children emotional regulation

时间窗: baseline; pre-intervention (one week before the intervention)

The Cognitive Emotion Regulation Questionnaire - Short (Garnefski \& Kraaij, 2006) is an 18-item self-report scale that measures a total of nine different cognitive coping strategies, each addressed by two items.

次要结局

  • child behavioral difficulties(baseline; pre-intervention (one week before the intervention))
  • Changes child mental health(post-test, one week after the intervention)
  • Children's irrational beliefs(baseline; pre-intervention (one week before the intervention))
  • changes in Children's irrational beliefs(post-test, one week after the intervention)
  • Mental health(baseline; pre-intervention (one week before the intervention))

研究者

发起方
Oana David
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Oana David

Professor Ph.D

Babes-Bolyai University

研究点 (1)

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