Evaluation of the Effect of the BOAT® Structured Prevention Program on Violence in Middle Schools (TheBOATeffect)

August 19, 2025 updated by: University Hospital, Montpellier
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
This computerized questionnaire will be sent via a link and completed directly and anonymously via the National Education Digital Workspace.
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
It will be sent to teaching teams and completed anonymously via the ENT (Digital Workspace) offered by the French Ministry of Education.
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
It will be sent to educational teams and completed via the ENT (digital Workspace)
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
in order to guide them towards an appropriate course of care.
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
The number of reports (information of concern or alerts)
every year at the end of the school year during three year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL22_0347 /UF 8352

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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