StudentsTheBOATeffectNCT06471413
Evaluation of the Effect of the BOAT® Structured Prevention Program on Violence in Middle Schools
An observational study of Students and Middle Schools, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Violence has major consequences for the health and development of children and teenagers, even though it is commonplace, particularly in secondary schools. The team at the Centre Ressources pour les Intervenants auprès d'Auteurs de Violences Sexuelles Languedoc-Roussillon (CRIAVS-LR, CHU Montpellier) has created a… Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Students, Middle Schools, Prevention
- What is being tested?
- The Prevention Toolbox : BOAT®
- How many people
- 5,400 participants
- Where
- 1 siteFrance
- Study dates
- 2 Apr 2025to 1 Sep 2027
- Phase
- Observational
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Population of students attending disadvantaged or very disadvantaged middle schools. 60 middle schools will take part in the study, representing a total of 5,400 pupils (one class of ninth graders selected at random per year and per school).
Who may be able to join
- Middle school students: students enrolled in a middle school included in the study, enrolled in the fourth or ninth grade and randomly selected to participate in the research. The age of a fourth or ninth grader is between 13 and 17.
- Educational team: professionals and teachers working in a middle school participating in the research (included in the study).
Who cannot join
- Schoolchildren: opposition to participation in the search by the child's parents (or one of the 2 parents with parental authority) and/or opposition by the child.
- Educational team: opposition to participation in the search.
- Person unable to speak French
- Person unable to understand the nature, purpose and methodology of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de MONTPELLIER
Montpellier, 34090
LACAMBRE, 0467338577, m-lacambre@chu-montpellier.fr
About this study
Violence has major consequences for the health and development of children and teenagers, even though it is commonplace, particularly in secondary schools. The team at the Centre Ressources pour les Intervenants auprès d'Auteurs de Violences Sexuelles Languedoc-Roussillon (CRIAVS-LR, CHU Montpellier) has created a BOite A ouTils to prevent sexual and gender-based violence: the BOAT, for professionals working with children and teenagers aged between 5 and 18. Structured around 5 themes and 4 age groups, the BOAT is very easy to use. The 134 intervention sheets have been validated and designed to target a risk factor (to be reduced) or a protective factor (to be developed) so that children do not become perpetrators or victims of violence.
Read the detailed description
The study will involve 60 middle school (10 middle school REP/REP+ in six academies) over four consecutive school years between 2023 and 2027, the first year being devoted to preparing the study with the establishment. The research project is coordinated by the Montpellier University Hospital, and regulatory approvals have been sought from the relevant authorities.
- Conditions
- Students, Middle Schools, Prevention, Violence
- Being tested
- The Prevention Toolbox : BOAT®
- Keywords
- prevention, violence, middle schools, sexual violence, abuse, sexism, BOAT
- Medical subject headings
- Sexism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Prevention Toolbox : BOAT®Other
The Prevention Toolbox targets all forms of violence, but in particular sexual and gender-based violence, through 1 out of 5 themes (Relationships and sexuality) and 10 out of 34 sub-themes. The other 4 themes (Psychosocial skills, Respect and difference, From the virtual to the real, and Understanding and respect for the law) cover all the risk and protection factors for all types of violence.
| Study group | Role | What they receive |
|---|---|---|
| Group BOAT + | The middle schools in the experimental group will benefit from the BOAT+ intervention, which involves training the school's educational team in the use of the BOAT®. Training is provided each year of the study to 5 members of the BOAT+ college educational team, in the form of e-learning supplemented by two half-day face-to-face sessions.
Trained professionals will use the BOAT® in real-life ecological conditions, according to their needs and educational projects. Receives: Other: The Prevention Toolbox : BOAT® | |
| Group BOAT - | No intervention will be carried out in the colleges of the control group, except to inform parents and educational teams about the research. The educational teams will not be trained to use the BOAT when the study is set up. These middle schools will benefit from the same annual evaluations (school, students and educational teams) as the BOAT+ middle schools. If the effect of the BOAT® structured prevention program is positive, the educational teams in the control group (BOAT-) will receive training in the use of the BOAT® at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the incidence of violent behavior
The incidence of violent behavior for each study period will be calculated by dividing the number of violent incidents observed in the school, by the number of schoolchildren monitored over the period (in person/year) in the same school.
Measured: between the three years preceding the middle school's inclusion (period without intervention) and the three years following the start of the study (period with or without intervention, depending on the intervention arm)
Secondary outcomes (5)
Students' well-being, substance use, risky sexual behavior and suicidal behavior
This computerized questionnaire will be sent via a link and completed directly and anonymously via the National Education Digital Workspace.
Measured: every year at the end of the school year during three year
Teachers' perceived stress at work will be assessed using the PSS (Perceived Stress Scale) validated in French
It will be sent to teaching teams and completed anonymously via the ENT (Digital Workspace) offered by the French Ministry of Education.
Measured: every year at the end of the school year during three year
School climate will be assessed using an anonymous ICS (Indice of School Climate ) questionnary
It will be sent to educational teams and completed via the ENT (digital Workspace)
Measured: every year at the end of the school year during three year
The frequency of disclosures of violence or abuse during interventions
in order to guide them towards an appropriate course of care.
Measured: every year at the end of the school year during three year
The number of reports (information of concern or alerts)
The number of reports (information of concern or alerts)
Measured: every year at the end of the school year during three year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start2 Apr 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StudentsStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471413
- Sponsor's protocol ID
- RECHMPL22_0347 /UF 8352
- Acronym
- TheBOATeffect
- Status last verified
- Aug 2025
- First submitted
- 18 Jun 2024
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of the BOAT® Structured Prevention Program on Violence in Middle Schools
- ClinicalTrials.gov ID
- NCT06471413
- Acronym / sponsor ID
- TheBOATeffect / RECHMPL22_0347 /UF 8352
- Conditions
- Students, Middle Schools, Prevention, Violence
- Keywords
- prevention, violence, middle schools, sexual violence, abuse, sexism, BOAT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,400 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 24 Jun 2024 (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.
Violence has major consequences for the health and development of children and teenagers, even though it is commonplace, particularly in secondary schools. The team at the Centre Ressources pour les Intervenants auprès d'Auteurs de Violences Sexuelles Languedoc-Roussillon (CRIAVS-LR, CHU Montpellier) has created a BOite A ouTils to prevent sexual and gender-based violence: the BOAT, for professionals working with children and teenagers aged between 5 and 18. Structured around 5 themes and 4 age groups, the BOAT is very easy to use. The 134 intervention sheets have been validated and designed to target a risk factor (to be reduced) or a protective factor (to be developed) so that children do not become perpetrators or victims of violence.
Detailed description
The study will involve 60 middle school (10 middle school REP/REP+ in six academies) over four consecutive school years between 2023 and 2027, the first year being devoted to preparing the study with the establishment. The research project is coordinated by the Montpellier University Hospital, and regulatory approvals have been sought from the relevant authorities.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group BOAT + | – | Other: The Prevention Toolbox : BOAT®The middle schools in the experimental group will benefit from the BOAT+ intervention, which involves training the school's educational team in the use of the BOAT®. Training is provided each year of the study to 5 members of the BOAT+ college educational team, in the form of e-learning supplemented by two half-day face-to-face sessions. Trained professionals will use the BOAT® in real-life ecological conditions, according to their needs and educational projects. |
| Group BOAT - | – | –No intervention will be carried out in the colleges of the control group, except to inform parents and educational teams about the research. The educational teams will not be trained to use the BOAT when the study is set up. These middle schools will benefit from the same annual evaluations (school, students and educational teams) as the BOAT+ middle schools. If the effect of the BOAT® structured prevention program is positive, the educational teams in the control group (BOAT-) will receive training in the use of the BOAT® at the end of the study. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Population of students attending disadvantaged or very disadvantaged middle schools. 60 middle schools will take part in the study, representing a total of 5,400 pupils (one class of ninth graders selected at random per year and per school).
Key inclusion criteria (2 listed)
- Middle school students: students enrolled in a middle school included in the study, enrolled in the fourth or ninth grade and randomly selected to participate in the research. The age of a fourth or ninth grader is between 13 and 17.
Key exclusion criteria (4 listed)
- Schoolchildren: opposition to participation in the search by the child's parents (or one of the 2 parents with parental authority) and/or opposition by the child.
- Educational team: opposition to participation in the search.
- Person unable to speak French
- Person unable to understand the nature, purpose and methodology of the study
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 |
|---|---|---|
| The Prevention Toolbox : BOAT®The Prevention Toolbox targets all forms of violence, but in particular sexual and gender-based violence, through 1 out of 5 themes (Relationships and sexuality) and 10 out of 34 sub-themes. The other 4 themes (Psychosocial skills, Respect and difference, From the virtual to the real, and Understanding and respect for the law) cover all the risk and protection factors for all types of violence. | Other | Group BOAT + |
Primary outcome
changes in the incidence of violent behavior
Time frame: between the three years preceding the middle school's inclusion (period without intervention) and the three years following the start of the study (period with or without intervention, depending on the intervention arm)
The incidence of violent behavior for each study period will be calculated by dividing the number of violent incidents observed in the school, by the number of schoolchildren monitored over the period (in person/year) in the same school.
5 secondary outcomes
Students' well-being, substance use, risky sexual behavior and suicidal behavior
Time frame: every year at the end of the school year during three year
Teachers' perceived stress at work will be assessed using the PSS (Perceived Stress Scale) validated in French
Time frame: every year at the end of the school year during three year
School climate will be assessed using an anonymous ICS (Indice of School Climate ) questionnary
Time frame: every year at the end of the school year during three year
The frequency of disclosures of violence or abuse during interventions
Time frame: every year at the end of the school year during three year
The number of reports (information of concern or alerts)
Time frame: every year at the end of the school year during three year
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 24 Aug 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Students and Middle Schools, run by University Hospital, Montpellier 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Aug 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?
Contact Mathieu LACAMBRE, PH (0467338577, m-lacambre@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in the incidence of violent behavior (time frame: between the three years preceding the middle school's inclusion (period without intervention) and the three years following the start of the study (period with or without intervention, depending on the intervention arm)). 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 24 Aug 2025.