Intervention in a Small-scale Study of Game Based Cognitive Change Skills
2022年9月6日 更新者：Oana David、Babes-Bolyai University
Testing the Modular Intervention in a Small-scale Study of Game Based Cognitive Change ER Skills Coaching With or Without EMI
This activity will have the objectives of preliminary testing user satisfaction, the feasibility of the platform and its preliminary efficacy
研究概览
详细说明
Preliminary efficacy will be tested in an emotion-regulation framework.
Children included in this study will be allocated to play Level 4 of the REThink game on cognitive change or to no intervention Control condition.
Children and adolescents in the intervention group will be distributed afterwards in two groups: with or without ecological momentary intervention (EMI) using the PsyPills app for following-up with the cognitive change ER personalized strategy reminder during a real exam situation.
Outcomes considered will be stress reactivity (both subjective and physiological) using EMA before, during and after the test (Colombo et al., 2020), and cognitive change, namely irrational and rational beliefs, and reflective functioning improvements.
研究类型
介入性
注册 (实际的)
78
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Cluj
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Cluj-Napoca、Cluj、罗马尼亚
- Babeș-Bolyai University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
10年 至 16年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- children and adolescents between 10 and 16 years old
- provided written parental consent
- able to access mobile/internet applications on their device
Exclusion Criteria:
- Intellectual disability or physical limitations precluded the use of the computer program
- Had a major mental health disorder
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：控制
控制组
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实验性的：Rethink game plus PsyPills
Rethink game followed by PsyPills
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REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention to reduce emotional symptoms of children and adolescents.
PsyPills is a mobile app designed to provide personalized psychological pills
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实验性的：Rethink Game
Rethink game only
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REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention to reduce emotional symptoms of children and adolescents.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Levels of rational and irrational beliefs
大体时间：Baseline
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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")
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Baseline
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Changes in levels of rational and irrational beliefs
大体时间：Post-intervention (one week after the intervention)
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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")
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Post-intervention (one week after the intervention)
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Levels of emotion-regulation
大体时间：Baseline
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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,
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Baseline
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Changes in levels of emotion-regulation
大体时间：Post-intervention (one week after the intervention)
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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,
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Post-intervention (one week after the intervention)
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Level of distress
大体时间：Post-intervention (one week after the intervention)
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Measured with Profile of Emotional Distress
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Post-intervention (one week after the intervention)
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Emotion regulation abilities
大体时间：Baseline
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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.
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Baseline
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Changes in emotion regulation abilities
大体时间：Post-intervention (one week after the intervention)
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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.
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Post-intervention (one week after the intervention)
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Reflective functioning
大体时间：Baseline
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The Reflective Functioning Questionnaire (RFQ ) is a 8-items questionnaire rated on a 7 points Likert scale from "Strongly disagree" to "Strongly agree" where higher scores represents a higher level of reflective functioning.
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Baseline
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Changes in reflective functioning
大体时间：Post-intervention (one week after the intervention)
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The Reflective Functioning Questionnaire (RFQ ) is a 8-items questionnaire rated on a 7 points Likert scale from "Strongly disagree" to "Strongly agree" where higher scores represents a higher level of reflective functioning.
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Post-intervention (one week after the intervention)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年6月10日
初级完成 (实际的)
2022年9月5日
研究完成 (实际的)
2022年9月7日
研究注册日期
首次提交
2022年6月15日
首先提交符合 QC 标准的
2022年6月16日
首次发布 (实际的)
2022年6月21日
研究记录更新
最后更新发布 (实际的)
2022年9月7日
上次提交的符合 QC 标准的更新
2022年9月6日
最后验证
2022年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Rethink game的临床试验
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Université Blaise Pascal, Clermont-Ferrand撤销