An interventional study of Tous Épanouis à l'École (TEAL Program) and Standard Health Education Sessions in Bullying of Child, Child Behavior Disorders and Social Behavior, sponsored by University Hospital, Grenoble. Active, not recruiting at 1 site in France. Open to participants aged 8 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Prevention
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.
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.
35 studies on the registry are indexed under Child Behavior Disorders; 10 are open to participants now.
This study's planned enrollment of 900 is above the median of 134 across 25 interventional studies indexed under Child Behavior Disorders.
Browse Child Behavior Disorders studies →University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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.
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.
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).
Time frame: Change from baseline (T1) to one month after the intervention (T2).
Change in Social Proximity Score
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.
Time frame: Change from baseline (T1) to one month after the intervention (T2).
Change in Psychosocial Skills
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.
Time frame: Change from baseline (T1) to one month after the intervention (T2).
Change in Altruistic Behaviors
Improvement in students' altruistic behaviors, assessed using the French version of the Child Altruism Scale (20 items). Measurements occur at T1, T2, and T3.
Time frame: Change from baseline (T1) to one month after the intervention (T2).
Perception of the Intervention by Healthcare Students (Focus Groups)
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.
Time frame: Collected one month after the intervention (T2)
Perception of the Intervention by Elementary School Teachers (Interviews)
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.
Time frame: Collected one month after the intervention (T2)
Perception of the Intervention by Students (Interviews)
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.
Time frame: Collected one month after the intervention (T2)
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
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This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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