EMBRACE YOUR POWER

N/ANot Yet RecruitingNCT07148219

University of Bucharest300 enrolled

Overview

The goal of this randomized controlled trial is to test the effectiveness of an educational tool, based on virtual reality (VR), for preventing and combating bullying and for improving the emotional well-being of pre-adolescent students. Participants will be allocated to one of two conditions: * (1) intervention group: Embrace your power intervention for combating bullying; * (2) waitlist (inactive control): the control group receives intervention after the study ends. The intervention group will be compared to the control group in terms of peer aggression and victimization (bullying behaviors) and emotional symptoms.

This protocol outlines a cluster, parallel-group, exploratory, randomized controlled trial where participants are randomly allocated to one of the two groups: intervention or control. * The main objective is to implement and assess the effectiveness of the program for combating bullying through virtual reality. The program aims to reduce victimization and bullying behaviors (physical, verbal, and relational aggression) by applying the APRI tool as a result of participating in VR scenarios that simulate these situations and to reduce emotional difficulties and behavioral problems, as well as increase prosocial behavior. * The included classes will serve as the randomization units. Students aged between 10 and 14 years, (5th and 6th grades from middle schools) will participate in the study. The intervention will last 7 weeks, and the two groups will be assessed at (1) pre-intervention (baseline), (2) middle of the intervention (week 3 or 4), and (3) post-intervention. The data analysis will focus on improvement in outcomes between and within groups.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

300

Interventions

Embrace Your Power: A VR Journey to Overcome Negative EmotionsBEHAVIORAL

EYP-VR represents a virtual reality (VR) educational tool to combat bullying. Using Meta Quest 3 passthrough technology, the app combines real-world classroom elements with immersive virtual scenarios, enabling safe and interactive experiences that simulate bullying situations but that do not place students in the roles of victims or aggressors but heroes or protectors. The app guides participants through narrative episodes focused on building empathy, practicing assertiveness, and learning conflict resolution techniques. AI-driven characters dynamically respond to students' actions as they engage in puzzles, and sensory feedback (visual, auditory, and haptic) reinforces key socio-emotional learning outcomes. The program will take place in classrooms during instructional hours. Each session will end with a feedback phase so that the school counselor can manage any issues that interest them.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Students 5th and 6th grade * Students whose parents have given their consent and who have also agreed to participate in the program Exclusion Criteria: * Medical problems that have VR-based procedures as contraindicated because they can induce dizziness, seizures, nausea: 1. epilepsy 2. presence of seizures 3. severe motion sickness- vestibular disorders 4. significant vision problems that would interfere with the use of the headset 5. severe migraines triggered by exposure to screens * Neurodevelopmental disorders 1. Autism spectrum disorder- level 3 of severity or sensory processing disorders 2. ADHD, if hyperactivity would prevent the student from staying in the exercise for longer * Points a) and b) do not represent automatic exclusion criteria, because depending on the judgment of the school counselor, the parent and the teacher, it is possible that a participant will be able to complete the program. * Severe mental disorders: psychotic spectrum disorders, post-traumatic stress disorder, present suicidal ideation * If children have an extremely low level of literacy perceived by the teacher and counselor, and this aspect would prevent them from participating in the program. * Parallel participation in other bullying prevention programs.

Outcomes

Primary Outcomes

Bullying behaviors

Bullying behaviors will be measured using the Adolescent Peer Relations Instrument (APRI) -C2. The instrument encompasses bullying victimization, perpetration, and bystander experiences. APRI represents a psychometric tool that measures teens' experiences with bullying and victimization through 36 items rated on a 6-point Likert scale (1= never, 6= every day).

Time frame: Pre-intervention (baseline), middle intervention, post-intervention (week 7)

Secondary Outcomes

Emotional symptoms

Emotional distress will be assessed using the Emotional Symptoms subscale from the Strengths and Difficulties Questionnaire - SDQ (Romanian self-report). The instrument consists of 25 items, and 5 items are representative of emotional symptoms. Items are rated on a 3-point Likert scale where 1= untrue and 3= certainly true.