REThink for Mental Health of the Youths in Romania (REThink)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bullying; Bullying of Child; Bullying Victimisation
• Intervention / Treatment: Behavioral: REThink Intervention

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oana David, Professor; Phone Number: +40-264-434141; Email: oanadavid@psychology.ro
• Study Contact Backup: Name: Cristina Tomoiaga, Ph.D; Phone Number: +40-264-434141; Email: cristinalorint@psychology.ro

Study Locations

• Romania
  • Cluj-Napoca, Romania, 400015
    • Babes-Bolyai University
    • Contact: Cristina Tomoiaga; Phone Number: 0751696209; Email: cristinalorint@psychology.ro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• internet and PC access to complete the scales and game

Exclusion Criteria:

• no internet or PC access

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: REThink; To ensure age-appropriate interventions, students below the age of 18 in the experimental group will receive the REThink game, while college-aged participants will engage with the REThink LIFE game.	Behavioral: REThink Intervention; At its core, the REThink game consists of seven levels, each focusing on a specific emotion-regulation skill crucial for emotional health. The game's story is based on the RETMAN character which helps the player fight the power of the "Irrationalizer" who personalizes irrational beliefs. The game is based on cognitive-behavioral psychotherapy - the unified protocol (Barlow et al., 2004) and well-supported Rational Emotive Behavioral Therapy (Ellis, 1995). Each level is composed of three sublevels, increasing in difficulty, and also has an embedded validated assessment system (composed of a sublevel for each level; David, Tomoiaga & Fodor, 2024), and can function as a standalone intervention.
No Intervention: Control; The students randomized in the control group will access the intervention after finalizing the post-test measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bullying	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	baseline assessment, one week before starting the intervention
Mental Health	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.	baseline assessment, one week before starting the intervention
Mental Health Stigma	The Stigma Scale measures mental health stigma. Lower scores represent an improvement. The minimum score is 9, and the maximum is 45.	baseline assessment, one week before starting the intervention
Stress	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	baseline assessment, one week before starting the intervention
Self-compassion	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.	baseline assessment, one week before starting the intervention
Compassion	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.	baseline assessment, one week before starting the intervention
Emotion regulation	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.	baseline assessment, one week before starting the intervention
Trauma Screening	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.	baseline assessment, one week before starting the intervention
Changes in bullying	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	post-test assessment, one week after finishing the intervention
Changes in mental health	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.	post-test assessment, one week after finishing the intervention
Changes in mental health stigma	The Stigma Scale measures mental health stigma. Lower scores represent an improvement. The minimum score is 9, and the maximum is 45.	post-test assessment, one week after finishing the intervention
Changes in stress	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	post-test assessment, one week after finishing the intervention
Changes in self-compassion	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.	post-test assessment, one week after finishing the intervention
Changes in compassion	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.	post-test assessment, one week after finishing the intervention
Changes in emotion regulation	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.	post-test assessment, one week after finishing the intervention

Collaborators and Investigators

• Sponsor: Babes-Bolyai University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Aggression; Bullying
• Other Study ID Numbers: REThinkBullying

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No