Prevention Workshop to Address Bullying Behaviors in Schools

NCT06835205 | Active Not Recruiting DMC

• 1 other identifier: PREPS-22-0015
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

This study, titled APACHES, is a cluster randomized controlled trial aimed at evaluating the effectiveness of a school-based prevention program, "Tous Épanouis à l'École" (TEAL), conducted by healthcare students as part of their mandatory public health service curriculum. The TEAL program consists of five interactive sessions focused on developing psychosocial skills (e.g., communication, empathy, collaboration) among elementary school students (grades CE2-CM1-CM2) in the Grenoble Academy. The primary objective is to assess whether the program reduces the prevalence of bullying behaviors (victims and/or aggressors) compared to standard preventive actions on unrelated themes. The study involves 36 classrooms across 18 schools, with data collected at three time points: before, one month after, and four months after the intervention. Secondary objectives include evaluating social proximity, altruistic behaviors, and qualitative perceptions from students, teachers, and facilitators.

Conditions

Bullying of Child; Child Behavior Disorders; Social Behavior; Mental Health; Interpersonal Relations; School Health Services; Prevention and Control

Keywords

Bullying Prevention; Psychosocial Skills; Elementary Education; Health Education; Student Well-Being; Cluster Randomized Trial; TEAL Program; School Climate; Public Health Intervention

Outcome Measures

Primary Outcomes (1)

• Prevalence of Bullying Behaviors (Victims and/or Aggressors)

  The proportion of students identified as victims, aggressors, or victim-aggressors based on the Revised Bully/Victim Questionnaire (rBVQ). Measured at three time points: before the intervention (T1), one month after the intervention (T2), and four months after the intervention (T3).

  Change from baseline (T1) to one month after the intervention (T2).

Secondary Outcomes (6)

• Change in Social Proximity Score

  Change from baseline (T1) to one month after the intervention (T2).

• Change in Psychosocial Skills

  Change from baseline (T1) to one month after the intervention (T2).

• Change in Altruistic Behaviors

  Change from baseline (T1) to one month after the intervention (T2).

• Perception of the Intervention by Healthcare Students (Focus Groups)

  Collected one month after the intervention (T2)

• Perception of the Intervention by Elementary School Teachers (Interviews)

  Collected one month after the intervention (T2)

Study Arms (2)

Intervention Group (TEAL Program)

EXPERIMENTAL

Students in this group will receive the "Tous Épanouis à l'École" (TEAL) program, a five-session intervention aimed at developing psychosocial skills, including empathy, communication, and social proximity. Sessions will be conducted by trained healthcare students as part of their Service Sanitaire curriculum. The program focuses on reducing bullying behaviors and improving classroom climate.

Behavioral: Tous Épanouis à l'École (TEAL Program)

Control Group (Standard Health Education)

ACTIVE COMPARATOR

Students in this group will participate in five health education sessions on topics unrelated to bullying (e.g., nutrition, sleep hygiene). These sessions will also be delivered by healthcare students following the standard Service Sanitaire training curriculum.

Behavioral: Standard Health Education Sessions

Interventions

Tous Épanouis à l'École (TEAL Program) BEHAVIORAL

The TEAL Program is a structured, five-session behavioral intervention targeting psychosocial skill development in children. Delivered by healthcare students in elementary school classrooms, the program includes interactive activities designed to improve communication, empathy, social proximity, and prosocial behaviors. The intervention aims to reduce bullying behaviors (victims and aggressors) and enhance classroom climate. Each session is guided by a detailed manual and includes active participation from students and their teachers.

Intervention Group (TEAL Program)

Standard Health Education Sessions BEHAVIORAL

This intervention consists of five sessions on general health topics unrelated to bullying, such as nutrition, sleep hygiene, and physical activity. The sessions are facilitated by healthcare students as part of their Service Sanitaire training. These sessions provide a comparable structure and duration to the TEAL program but do not address bullying prevention.

Control Group (Standard Health Education)

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Students enrolled in grades CE2, CM1, or CM2 in participating schools.
• Parents or legal guardians have provided signed informed consent for their child to participate in the study.
• The child is available to attend all scheduled intervention sessions.

You may not qualify if:

• Students whose parents or legal guardians have not provided signed informed consent.
• Students with medical or behavioral conditions that might prevent full participation in the sessions (e.g., requiring additional support not available during the study).
• Students not attending the school on a regular basis.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Université Lumière Lyon 2: collaborator
• University Grenoble Alps: collaborator
• Maison des Sciences de l'Homme et de la société: collaborator
• Grenoble Academy: collaborator

Study Sites (1)

Académie de Grenoble

Grenoble, 38032, France

Location

MeSH Terms

Conditions

Child Behavior Disorders; Social Behavior; Psychological Well-Being; Health Education

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Behavior; Personal Satisfaction; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Bastien Boussat, MD, PhD

  University Grenoble Alpes, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Although the study is open-label for participants, care providers, and investigators, the statistician conducting the data analysis will remain blinded to group allocation. This ensures unbiased interpretation of the results.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a cluster randomized controlled trial where classrooms are randomized into two groups: the intervention group receives the TEAL program, and the control group participates in unrelated health education sessions.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 19, 2025
• Study Start: October 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD and supporting information will be available starting 6 months after publication of the primary results. Data and documents will remain accessible for 5 years post-publication.
• Access Criteria: Researchers with a scientifically sound proposal may request access to the IPD and supporting documents. Requests must include a detailed research plan and intended use of the data, subject to approval by the study's steering committee. Approved users will sign a data access agreement and will access the data through a secure data-sharing platform. Contact: bboussat@chu-grenoble.fr.

Locations

FR (1)