Clinical trial NCT06835205: Prevention Workshop to Address Bullying Behaviors in Schools
Official title: Prevention Workshop to Address Bullying Behaviors in Schools: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Université Lumière Lyon 2
name: University Grenoble Alps
name: Maison des Sciences de l'Homme et de la société
name: Grenoble Academy
First posted: 2025-02-19
Enrollment: 900
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: Bullying is a critical public health issue with severe consequences for children's psychological development, academic success, and long-term health outcomes. The APACHES study evaluates the effectiveness of the TEAL program, a psychosocial skills training intervention tailored to reduce bullying behaviors and improve classroom climate. The intervention will be delivered by healthcare students (from medicine, midwifery, pharmacy, and nursing) as part of their Service Sanitaire curriculum.

The study follows a pragmatic design with a cluster randomized controlled methodology. Classrooms in participating schools are randomized into two groups: an intervention group receiving the TEAL program and a control group undergoing alternative health education sessions. The TEAL program is structured around active and participatory learning, including sessions on emotional awareness, communication, empathy, and collective problem-solving. A total of 900 students from 36 classrooms (approximately 450 per group) will participate.

Objectives Primary Objective: To determine whether the TEAL program reduces the prevalence of bullying (victims and/or aggressors) by comparing baseline and follow-up outcomes.

Secondary Objectives: To explore improvements in social proximity, altruistic behaviors, and psychosocial skills; to collect qualitative feedback from students, facilitators, and teachers about the intervention.

Data Collection and Outcomes Quantitative data will be collected using validated questionnaires (e.g., Revised Bully/Victim Questionnaire) administered at three time points: pre-intervention (T1), one month post-intervention (T2), and four months post-intervention (T3). Secondary outcomes, including social proximity and altruism, will also be assessed. Qualitative data will be gathered through interviews and focus groups to evaluate participants' experiences and perceptions.

Significance This study aims to address a pressing public health need by leveraging healthcare students' involvement in primary prevention. If effective, the TEAL program could be scaled nationally across France, contributing to the broader goal of improving psychosocial environments in schools and mitigating the long-term effects of bullying.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Prevalence of Bullying Behaviors (Victims and/or Aggressors)
timeFrame: Change from baseline (T1) to one month after the intervention (T2).
Secondary outcomes:
measure: Change in Social Proximity Score
timeFrame: Change from baseline (T1) to one month after the intervention (T2).
measure: Change in Psychosocial Skills
timeFrame: Change from baseline (T1) to one month after the intervention (T2).
measure: Change in Altruistic Behaviors
timeFrame: Change from baseline (T1) to one month after the intervention (T2).
measure: Perception of the Intervention by Healthcare Students (Focus Groups)
timeFrame: Collected one month after the intervention (T2)
measure: Perception of the Intervention by Elementary School Teachers (Interviews)
timeFrame: Collected one month after the intervention (T2)
measure: Perception of the Intervention by Students (Interviews)
timeFrame: Collected one month after the intervention (T2)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Académie de Grenoble
Study officials:
affiliation: University Grenoble Alpes, Faculty of Medicine
name: Bastien Boussat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: