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临床试验/NCT06646159
NCT06646159尚未招募不适用

REThink for Mental Health of the Youths in Romania

Babes-Bolyai University2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
试验地点
2
主要终点
Mental Health Stigma

研究概览

简要总结

In order to test the effect of the intervention, a multi-center randomized control trial (RCT) will be conducted to test the efficacy of the REThink interventions on improving bullying (both victimization and aggression) and mental health compared with a care as usual group. A minimum of 1000 students from the participating institutions (schools will be able to join based on a recruitment call), will be recruited and randomly assigned to either the experimental or control group.

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
None

入排标准

年龄范围
10 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • internet and PC access to complete the scales and game

排除标准

  • no internet or PC access

结局指标

主要结局

Mental Health Stigma

时间窗: baseline assessment, one week before starting the intervention

The Stigma Scale measures mental health stigma. Lower scores represent an improvement. The minimum score is 9, and the maximum is 45.

Bullying

时间窗: baseline assessment, one week before starting the intervention

Bullying and Cyberbullying Scale for Adolescents will be used to measure bullying. The scale is composed of 26 items, the minimum score is 26 and the maximum 130. Higher scores represent higher levels of bullying

Mental Health

时间窗: baseline assessment, one week before starting the intervention

Depression, Anxiety, and Stress Scale is used for mental healh. For this scale, lower scores represent lower levels of anxiety, depression and stress, the minimum score is 0 and maximum score is 63.

Stress

时间窗: baseline assessment, one week before starting the intervention

MoodWheel instrumentis used to measure stress. The scale is composed of 32 items representing emotions which are divided into four subscales: positive functional emotions, positive dysfunctional emotions, negative functional and negative dysfunctional emotions. Scores at each subscale represent higher levels of that category of emotion.The minimum score is 0 and the maximum is 160

Self-compassion

时间窗: baseline assessment, one week before starting the intervention

The Self-Compassion Scale Short Form is used to measure self-compassion. The scale has two dimensions, namely Self-Care, where higher scores represent higher levels of self-care, and Self-Disparagement, where lower scores represent an improvement.The minim score is 12 and the maximum is 60.

Compassion

时间窗: baseline assessment, one week before starting the intervention

Compassion Scale for children is a valid and reliable measurement tool that will be able to determine the level of compassion of children between the ages of 10 to 18-year-olds.The minimum score is 9, and maximum is 54.

Emotion regulation

时间窗: baseline assessment, one week before starting the intervention

The in-game assessment for each REThink intervention. This assessment system is the trial version of the game with sections for each level and very good psychometric properties. For this system, higher scores represent higher levels of various emotion-regulation abilities.

Trauma Screening

时间窗: baseline assessment, one week before starting the intervention

Childhood Trauma Screener is used to measure past traumatic experiences .The scale is composed of 5 items each representing a type of trauma or abuse. Higher scores represent higher frequency of abuse and/or trauma. The minimum score is and the maximum score is 5 and the maximum 25.

Changes in bullying

时间窗: post-test assessment, one week after finishing the intervention

Bullying and Cyberbullying Scale for Adolescents will be used to measure bullying. The scale is composed of 26 items, the minimum score is 26 and the maximum 130. Higher scores represent higher levels of bullying

Changes in mental health

时间窗: post-test assessment, one week after finishing the intervention

Depression, Anxiety, and Stress Scale is used for mental healh. For this scale, lower scores represent lower levels of anxiety, depression and stress, the minimum score is 0 and maximum score is 63.

Changes in mental health stigma

时间窗: post-test assessment, one week after finishing the intervention

The Stigma Scale measures mental health stigma. Lower scores represent an improvement. The minimum score is 9, and the maximum is 45.

Changes in stress

时间窗: post-test assessment, one week after finishing the intervention

MoodWheel instrumentis used to measure stress. The scale is composed of 32 items representing emotions which are divided into four subscales: positive functional emotions, positive dysfunctional emotions, negative functional and negative dysfunctional emotions. Scores at each subscale represent higher levels of that category of emotion.The minimum score is 0 and the maximum is 160

Changes in self-compassion

时间窗: post-test assessment, one week after finishing the intervention

The Self-Compassion Scale Short Form is used to measure self-compassion. The scale has two dimensions, namely Self-Care, where higher scores represent higher levels of self-care, and Self-Disparagement, where lower scores represent an improvement.The minim score is 12 and the maximum is 60.

Changes in compassion

时间窗: post-test assessment, one week after finishing the intervention

Compassion Scale for children is a valid and reliable measurement tool that will be able to determine the level of compassion of children between the ages of 10 to 18-year-olds.The minimum score is 9, and maximum is 54.

Changes in emotion regulation

时间窗: post-test assessment, one week after finishing the intervention

The in-game assessment for each REThink intervention. This assessment system is the trial version of the game with sections for each level and very good psychometric properties. For this system, higher scores represent higher levels of various emotion-regulation abilities.

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 (2)

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