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临床试验/NCT06085391
NCT06085391已完成不适用

Testing the Efficacy of the REThink Emotions Platform in a Full-scale SMART Study

Babes-Bolyai University1 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2023年10月7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
185
试验地点
1
主要终点
Fluctuations in emotion-regulation

研究概览

简要总结

This activity will have the objective of testing the validity of the integrated in-game assessment and personalized REThinkEMOTIONS platform in the prevention of emotional disorders in youth.

研究设计

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

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children and adolescents between 8 and 16 years old
  • provided written parental consent
  • able to access mobile/internet applications on their device

排除标准

  • Intellectual disability or physical limitations precluded the use of the computer program
  • Had a major mental health disorder

结局指标

主要结局

Fluctuations in emotion-regulation

时间窗: 6 months Follow-up

The Emotion Regulation Index for Children and Adolescents (ERICA). It is a 13-item on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilities,

Fluctuations in child behavioral difficulties

时间窗: 6 months follow-up

Strengths and Difficulties Questionnaire (SDQ) is a self-report scale that measures emotional and behavioral difficulties in children and adolescents. Its is composed of items and 25 items ranked on a three points Liker scale from "not true" to "almost true". Greater scores at this scale represent higher level of difficulties.

Levels of rational and irrational beliefs

时间窗: baseline, pre-intervention

The Child and Adolescent Scale of Irrationality will be used in order to test irrational/rational beliefs as a mechanism of change. Children and adolescents were asked to express their agreement/disagreement with the 28 statements on a 5-point Likert-type scale, from 1 ("strong disagreement") to 5 ("strong agreement")

Changes of rational and irrational beliefs

时间窗: Post-intervention (one week after the intervention)

The Child and Adolescent Scale of Irrationality will be used in order to test irrational/rational beliefs as a mechanism of change. Children and adolescents were asked to express their agreement/disagreement with the 28 statements on a 5-point Likert-type scale, from 1 ("strong disagreement") to 5 ("strong agreement")

Fluctuations in of rational and irrational beliefs

时间窗: 6 months Follow-up

The Child and Adolescent Scale of Irrationality will be used in order to test irrational/rational beliefs as a mechanism of change. Children and adolescents were asked to express their agreement/disagreement with the 28 statements on a 5-point Likert-type scale, from 1 ("strong disagreement") to 5 ("strong agreement")

Levels of child behavioral difficulties

时间窗: Pre-intervention (one week before the intervention)

Strengths and Difficulties Questionnaire (SDQ) is a self-report scale that measures emotional and behavioral difficulties in children and adolescents. Its is composed of items and 25 items ranked on a three points Liker scale from "not true" to "almost true". Greater scores at this scale represent higher level of difficulties.

Changes in child behavioral difficulties

时间窗: Post-intervention (one week after the intervention)

Strengths and Difficulties Questionnaire (SDQ) is a self-report scale that measures emotional and behavioral difficulties in children and adolescents. Its is composed of items and 25 items ranked on a three points Liker scale from "not true" to "almost true". Greater scores at this scale represent higher level of difficulties.

Levels of emotion-regulation

时间窗: baseline, pre-intervention

The Emotion Regulation Index for Children and Adolescents (ERICA) It is a 13-item on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilities,

Changes in emotion-regulation

时间窗: Post-intervention (one week after the intervention)

The Emotion Regulation Index for Children and Adolescents (ERICA). It is a 13-item on a five-point Likert scale, from 0 "strong disagreement" to 5"strong agreement" where higher scores represent better emotional regulation abilities,

次要结局

  • Level of emotional distress(baseline, pre-intervention)
  • Changes in emotional distress(Post-intervention (one week after the intervention))
  • Fluctuations in emotional distress(6 months follow-up)

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 Ph.D of Clinical Psychology

Babes-Bolyai University

研究点 (1)

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