- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06835205
Prevention Workshop to Address Bullying Behaviors in Schools (APACHES)
Prevention Workshop to Address Bullying Behaviors in Schools: A Cluster Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Grenoble, France, 38032
- Académie de Grenoble
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group (TEAL Program)
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.
|
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.
|
|
Active Comparator: Control Group (Standard Health Education)
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of Bullying Behaviors (Victims and/or Aggressors)
Time Frame: Change from baseline (T1) to one month after the intervention (T2).
|
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).
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Change from baseline (T1) to one month after the intervention (T2).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Social Proximity Score
Time Frame: Change from baseline (T1) to one month after the intervention (T2).
|
Assessment of the social proximity among students using a validated scale.
The change in scores will be measured at T1, T2, and T3 to evaluate the intervention's impact on fostering closer social relationships.
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Change from baseline (T1) to one month after the intervention (T2).
|
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Change in Psychosocial Skills
Time Frame: Change from baseline (T1) to one month after the intervention (T2).
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Improvement in psychosocial skills such as empathy, communication, and emotional regulation, measured via a validated psychosocial skill scale.
Changes are assessed at T1, T2, and T3.
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Change from baseline (T1) to one month after the intervention (T2).
|
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Change in Altruistic Behaviors
Time Frame: Change from baseline (T1) to one month after the intervention (T2).
|
Improvement in students' altruistic behaviors, assessed using the French version of the Child Altruism Scale (20 items).
Measurements occur at T1, T2, and T3.
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Change from baseline (T1) to one month after the intervention (T2).
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Perception of the Intervention by Healthcare Students (Focus Groups)
Time Frame: Collected one month after the intervention (T2)
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Exploration of the perceptions and experiences of healthcare students who facilitated the TEAL program, gathered through focus groups.
Topics include perceived impact, challenges, and learning outcomes from the intervention.
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Collected one month after the intervention (T2)
|
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Perception of the Intervention by Elementary School Teachers (Interviews)
Time Frame: Collected one month after the intervention (T2)
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Feedback from teachers in the TEAL group on the program's impact on classroom dynamics, bullying behaviors, and overall implementation.
Data are collected through semi-structured interviews.
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Collected one month after the intervention (T2)
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Perception of the Intervention by Students (Interviews)
Time Frame: Collected one month after the intervention (T2)
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Qualitative feedback from children in the TEAL group on their experiences with the program, including perceived benefits, engagement, and understanding of key themes.
Data are collected via semi-structured interviews.
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Collected one month after the intervention (T2)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bastien Boussat, MD, PhD, University Grenoble Alpes, Faculty of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PREPS-22-0015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual participant data (IPD) that underlie the results reported in the publication (after de-identification) will be shared with researchers upon reasonable request. Data will include:
Demographic variables Outcome measures (e.g., bullying behaviors, psychosocial skills, and social proximity scores) Qualitative data (e.g., thematic analysis results from focus groups and interviews) Data will be available beginning 6 months after publication and ending 5 years after publication. Requests for data sharing must include a detailed proposal that is approved by the study's steering committee. Access will be granted through a secure data-sharing platform. Contact information for data requests: bboussat@chu-grenoble.fr.
IPD Sharing Time Frame
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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