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临床试验/NCT05257642
NCT05257642已完成不适用

Testing the Usability of the REThink Game and the Efficacy of Its Main Game-based ER Strategies on the Stress Reactivity of Children and Adolescents

Babes-Bolyai University1 个研究点 分布在 1 个国家目标入组 146 人开始时间: 2022年3月10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
146
试验地点
1
主要终点
Level of distress

研究概览

简要总结

This activity will aim to test the comparative efficacy of the main game-based emotion-regulation abilities training of the REThink online game: cognitive change, biofeedback and problem-solving in reducing stress reactivity of the children and adolescents

详细描述

Children included in this study (aged 8-16 years, G*Power estimated N=98) will be allocated to one of the three experimental conditions (cognitive change, biofeedback and problem-solving game based training based on the REThink online game levels), or no intervention Control condition. All children will be exposed afterwards to psychosocial stress in the form of peer rejection "ball toss" task. It will be measure both game-based skills outcomes, and EMA stress reactivity outcomes.

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 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 provided written parental consent

排除标准

  • Intellectual disability or physical limitations precluded the use of the computer program

结局指标

主要结局

Level of distress

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

Measured with Profile of Emotional Distress

Levels of rational and irrational beliefs

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

The Child and Adolescent Scale of Irrationality (CASI, Bernard \& Cronan, 1999) 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 in rational and irrational beliefs

时间窗: Post-intervention (one week afterthe intervention)

The Child and Adolescent Scale of Irrationality (CASI, Bernard \& Cronan, 1999) 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 mindfulness

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

The Mindfulness Awarness Attention Scale - Child version (MAAS-C, Lawlor, Reichl \& Zumbo, 2014) is a 15-items questionnaire rated on a 6 points Likert scale from "almost never" to "almost every time" where higher scores means higher mindfulness.

Changes in levels of mindfulness

时间窗: Post-intervention (one week afterthe intervention)

The Mindfulness Awarness Attention Scale - Child version (MAAS-C, Lawlor, Reichl \& Zumbo, 2014) is a 15-items questionnaire rated on a 6 points Likert scale from "almost never" to "almost every time" where higher scores means higher mindfulness.

Levels of well-being

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

WHO-5 Well-being Index

Changes in levels of well-being

时间窗: Post-intervention (one week afterthe intervention)

WHO-5 Well-being Index

Levels of emotion-regulation

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

The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001). 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 levels of emotion-regulation

时间窗: Post-intervention (one week afterthe intervention)

The Emotion Regulation Index for Children and Adolescents (ERICA; Biesecker \& Easterbrooks, 2001). 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 level of distress

时间窗: Post-intervention (one week afterthe intervention)

Measured with Profile of Emotional Distress

Children Emotional Abilities

时间窗: 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.

Changes in children Emotional Abilities

时间窗: Post-intervention (one week afterthe 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

未报告次要终点

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

Babes-Bolyai University

研究点 (1)

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