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Clinical Trials/NCT06646159
NCT06646159
Not yet recruiting
Not Applicable

REThink for Mental Health of the Youths in Romania

Babes-Bolyai University1 site in 1 country1,000 target enrollmentSeptember 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bullying of Child
Sponsor
Babes-Bolyai University
Enrollment
1000
Locations
1
Primary Endpoint
Mental Health Stigma
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2025
End Date
December 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Babes-Bolyai University
Responsible Party
Principal Investigator
Principal Investigator

Oana David

Professor Ph.D of Clinical Psychology

Babes-Bolyai University

Eligibility Criteria

Inclusion Criteria

  • internet and PC access to complete the scales and game

Exclusion Criteria

  • no internet or PC access

Outcomes

Primary Outcomes

Mental Health Stigma

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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