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临床试验/NCT04949620
NCT04949620已完成不适用

REThinkWELL: An Evidence-based Integrative Platform for the Prevention of Emotional Disorders in Children and Promotion of Children's Emotional Health

Babes-Bolyai University2 个研究点 分布在 1 个国家目标入组 256 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
256
试验地点
2
主要终点
Children's emotional symptoms

研究概览

简要总结

The general objective of the study is to test an online platform for the promotion of emotional health in children

详细描述

The project aims at implementing an integrated online therapeutic platform that will be accessed by youth, parents and clinicians. The main original feature is the integration of state of the art online/mobile and gaming technologies into a unique platform that allows easy access to personalized, accessible and validated prevention.

The platform aims to allow access to attractive, easily accessible and evidence-based prevention for youths. The system will be validated in the second step as an integrative, multi-componential and adaptive platform for the prevention of emotional disorders in youth. The platform includes tools that were separately tested in laboratory conditions and found to be effective: the REThink therapeutic video game and the online REThink Parenting and Rational Parent Coach mobile programs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
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
  • scores above average at any subscale of Childhood Trauma Questionnaire
  • parental consent provided
  • for the parental intervention: no changes in children's main outcomes following the REThink intervention

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

Children's emotional symptoms

时间窗: baseline

The Child Behavior Checklist for ages 6-18 (CBCL; Achenbach \& Rescorla, 2001) is a parent-report of child emotional and behavioral problems. Each item is rated on a 3-point Likert-style scale ranging from 0 (not true) to 2 (very true or often true). The DSM-derived affective and anxiety scales and the anxious/depressed and withdrawn/depressed syndrome scales, respectively, will be used to assess emotional symptoms.

Changes in children's emotional symptoms - immediately

时间窗: immediately post first-stage intervention (4 weeks following baseline)

The Child Behavior Checklist for ages 6-18 (CBCL; Achenbach \& Rescorla, 2001) is a parent-report of child emotional and behavioral problems. Each item is rated on a 3-point Likert-style scale ranging from 0 (not true) to 2 (very true or often true). The DSM-derived affective and anxiety scales and the anxious/depressed and withdrawn/depressed syndrome scales, respectively, will be used to assess emotional symptoms.

次要结局

  • Child irrationality(baseline)
  • Changes in child irrationality(immediately post first-stage intervention (4 weeks following baseline))
  • Child behavioral difficulties(baseline)
  • Child trauma(baseline)
  • Changes in child behavioral difficulties(immediately post first-stage intervention (4 weeks following baseline))
  • Changes in children emotional abilities(immediately post first-stage intervention (4 weeks following baseline))

研究者

发起方
Babes-Bolyai University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oana David

Professor

Babes-Bolyai University

研究点 (2)

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