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临床试验/NCT05424601
NCT05424601已完成不适用

Testing the Modular Intervention in a Small-scale Study of Game Based Cognitive Change ER Skills Coaching with or Without EMI

Babes-Bolyai University1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2022年6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
165
试验地点
1
主要终点
Levels of rational and irrational beliefs

研究概览

简要总结

This activity will have the objectives of preliminary testing user satisfaction, the feasibility of the platform and its preliminary efficacy

详细描述

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
10 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children and adolescents between 10 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

Levels of rational and irrational beliefs

时间窗: Baseline

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 levels of rational and irrational beliefs

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

Emotion regulation abilities

时间窗: Baseline

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 emotion regulation abilities

时间窗: Post-intervention (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.

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 of Clinical Psychology

Babes-Bolyai University

研究点 (1)

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