Bullying of ChildAPACHESNCT06835205
Prevention Workshop to Address Bullying Behaviors in Schools
A study testing Tous Épanouis à l'École (TEAL Program) and Standard Health Education Sessions in people with Bullying of Child and Child Behavior Disorders, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Bullying of Child, Child Behavior Disorders, Social Behavior
- What is being tested?
- Tous Épanouis à l'École (TEAL Program) and Standard Health Education Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention Workshop to Address Bullying Behaviors in Schools: A Cluster Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Bullying of Child, Child Behavior Disorders, Social Behavior, Mental Health, Interpersonal Relations, School Health Services
- Being tested
- Tous Épanouis à l'École (TEAL Program), Standard Health Education Sessions
- Keywords
- Bullying Prevention, Psychosocial Skills, Elementary Education, Health Education, Student Well-Being, Cluster Randomized Trial, TEAL Program, School Climate, Public Health Intervention
- Medical subject headings
- Child Behavior Disorders, Social Behavior, Psychological Well-Being, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tous Épanouis à l'École (TEAL Program)Behavioural
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.
Standard Health Education SessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Health Education Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline (T1) to one month after the intervention (T2).
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Collected one month after the intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Oct 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullying of ChildStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Université Lumière Lyon 2, University Grenoble Alps, Maison des Sciences de l'Homme et de la société, Grenoble Academy
- Responsible party
- Sponsor
- Investigators
- Bastien Boussat, MD, PhD, Principal investigator, University Grenoble Alpes, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835205
- Sponsor's protocol ID
- PREPS-22-0015
- Acronym
- APACHES
- Status last verified
- Feb 2025
- First submitted
- 13 Jan 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention Workshop to Address Bullying Behaviors in Schools: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06835205
- Acronym / sponsor ID
- APACHES / PREPS-22-0015
- Conditions
- Bullying of Child, Child Behavior Disorders, Social Behavior, Mental Health, Interpersonal Relations, School Health Services
- Keywords
- Bullying Prevention, Psychosocial Skills, Elementary Education, Health Education, Student Well-Being, Cluster Randomized Trial, TEAL Program, School Climate
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Université Lumière Lyon 2, University Grenoble Alps, Maison des Sciences de l'Homme et de la société, Grenoble Academy
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (TEAL Program) | Experimental | Behavioral: Tous Épanouis à l'École (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. |
| Control Group (Standard Health Education) | Active comparator | Behavioral: Standard Health Education SessionsStudents 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. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tous Épanouis à l'École (TEAL Program)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. | Behavioural | Intervention Group (TEAL Program) |
| Standard Health Education SessionsThis 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. | Behavioural | Control Group (Standard Health Education) |
Primary outcome
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).
6 secondary outcomes
Change in Social Proximity Score
Time frame: Change from baseline (T1) to one month after the intervention (T2).
Change in Psychosocial Skills
Time frame: Change from baseline (T1) to one month after the intervention (T2).
Change in Altruistic Behaviors
Time frame: Change from baseline (T1) to one month after the intervention (T2).
Perception of the Intervention by Healthcare Students (Focus Groups)
Time frame: Collected one month after the intervention (T2)
Perception of the Intervention by Elementary School Teachers (Interviews)
Time frame: Collected one month after the intervention (T2)
Perception of the Intervention by Students (Interviews)
Time frame: Collected one month after the intervention (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bastien Boussat, MD, PhD principal investigator
University Grenoble Alpes, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tous Épanouis à l'École (TEAL Program) and Standard Health Education Sessions in people with Bullying of Child and Child Behavior Disorders, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Bullying Behaviors (Victims and/or Aggressors) (time frame: Change from baseline (T1) to one month after the intervention (T2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.