Public HealthImpexNCT06400758
Impact/Interest of a Collective Prevention Intervention in Sexual and Emotional Health
An observational study of Public Health, run by Pole Sante Grace de Dieu at 1 site in France.
Trial summary
Main objective To measure the effects of a group prevention intervention on the sexual and affective knowledge of high school students in the Basse-Normandie region. Secondary objective Take stock of what is known about the sexual and emotional health of teenagers. Read more about this study
- Who is it for?
- Ages 15 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Public Health
- What is being tested?
- questionary
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2024to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Intervention in a school setting. This intervention is part of a biology course (Life and Earth Sciences). It is a class project. Theoretically, all high school students are recruited.
Who may be able to join
- school students in the 2023-2024 school year
Who cannot join
- A newsletter was sent to the school's head teachers, the students' parents and the students themselves, informing them of the possible use of the data for research purposes, and the possibility of objecting. The principal teachers provided information on the non-obligation to respond during the distribution of the questionnaires. Students who did not respond to the questionnaire were therefore not included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact/Interest of a Collective Prevention Intervention in Sexual and Emotional Health Among High School Students in Lower Normandy
Main objective To measure the effects of a group prevention intervention on the sexual and affective knowledge of high school students in the Basse-Normandie region.
Secondary objective Take stock of what is known about the sexual and emotional health of teenagers.
Read the detailed description
With the average age at first sexual intercourse in France being 17.6 for girls and 17.2 for boys, according to the 2010 health barometer, sexuality education and prevention seem essential at this age, and upstream.
An Australian qualitative study of young men aged 18 to 24 revealed that the main obstacles to discussing sexual health in general practice included the possibility of embarrassment and the fact that the subject was private. Most said they would only talk to their doctor about a sexual problem if it was very important or urgent: if not, they would prefer to wait for the doctor to initiate the subject.
Sexual health prevention initiatives are therefore essential outside the general practitioner's office, and have been shown to be effective in high schools. This is why the PSLA de la Grâce de Dieu has initiated sexual and emotional health prevention initiatives for students at a high school in Caen.
It therefore seemed interesting to assess these students' knowledge of sexual and emotional health before the PSLA's intervention in the amphitheatre with the students, and then after the intervention, in order to find out whether this large-scale prevention action had an impact on these students' knowledge, in the short and medium term.
- Conditions
- Public Health
- Being tested
- questionary
- Keywords
- prevention, sexual health, students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionaryOther
A questionnaire, based on the main sexual health topics frequently discussed, was given to students by the school management prior to an intervention.
The preventive intervention consisted of comprehensive prevention on the emotional and sexual lives of adolescents. It was carried out by health professionals and was based on questions from the students, who were able to leave their questions anonymously in a box in the school infirmary for several months.
These questions were collected and used to identify several themes for discussion:
emotional life, with notions of affection, love, friendship and the notion of "normality", as well as consent and sexual violence physical and sexual aspects, with reminders of the menstrual cycle, contraception, sexually transmitted infections, pregnancy and abortion.
The same questionnaire was given to students after the intervention, to check whether the prevention intervention had improved their general knowledge.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of knowledge improvement between before and after the intervention
the accuracy of correct answers between before and after intervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start14 Mar 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Public HealthStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pole Sante Grace de Dieu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400758
- Sponsor's protocol ID
- 20240205
- Acronym
- Impex
- Status last verified
- May 2025
- First submitted
- 30 Apr 2024
- Last updated
- 31 May 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 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact/Interest of a Collective Prevention Intervention in Sexual and Emotional Health Among High School Students in Lower Normandy
- ClinicalTrials.gov ID
- NCT06400758
- Acronym / sponsor ID
- Impex / 20240205
- Conditions
- Public Health
- Keywords
- prevention, sexual health, students
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Pole Sante Grace de DieuUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 6 May 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.
Main objective To measure the effects of a group prevention intervention on the sexual and affective knowledge of high school students in the Basse-Normandie region.
Secondary objective Take stock of what is known about the sexual and emotional health of teenagers.
Detailed description
With the average age at first sexual intercourse in France being 17.6 for girls and 17.2 for boys, according to the 2010 health barometer, sexuality education and prevention seem essential at this age, and upstream.
An Australian qualitative study of young men aged 18 to 24 revealed that the main obstacles to discussing sexual health in general practice included the possibility of embarrassment and the fact that the subject was private. Most said they would only talk to their doctor about a sexual problem if it was very important or urgent: if not, they would prefer to wait for the doctor to initiate the subject.
Sexual health prevention initiatives are therefore essential outside the general practitioner's office, and have been shown to be effective in high schools. This is why the PSLA de la Grâce de Dieu has initiated sexual and emotional health prevention initiatives for students at a high school in Caen.
It therefore seemed interesting to assess these students' knowledge of sexual and emotional health before the PSLA's intervention in the amphitheatre with the students, and then after the intervention, in order to find out whether this large-scale prevention action had an impact on these students' knowledge, in the short and medium term.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Intervention in a school setting. This intervention is part of a biology course (Life and Earth Sciences). It is a class project. Theoretically, all high school students are recruited.
Key inclusion criteria (1 listed)
- school students in the 2023-2024 school year
Key exclusion criteria (1 listed)
- A newsletter was sent to the school's head teachers, the students' parents and the students themselves, informing them of the possible use of the data for research purposes, and the possibility of objecting. The principal teachers provided information on the non-obligation to respond during the distribution of the questionnaires. Students who did not respond to the questionnaire were therefore not included.
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 |
|---|---|---|
| questionaryA questionnaire, based on the main sexual health topics frequently discussed, was given to students by the school management prior to an intervention. The preventive intervention consisted of comprehensive prevention on the emotional and sexual lives of adolescents. It was carried out by health professionals and was based on questions from the students, who were able to leave their questions anonymously in a box in the school infirmary for several months. These questions were collected and used to identify several themes for discussion: emotional life, with notions of affection, love, friendship and the notion of "normality", as well as consent and sexual violence physical and sexual aspects, with reminders of the menstrual cycle, contraception, sexually transmitted infections, pregnancy and abortion. The same questionnaire was given to students after the intervention, to check whether the prevention intervention had improved their general knowledge. | Other | – |
Primary outcome
Rate of knowledge improvement between before and after the intervention
Time frame: 1 year
the accuracy of correct answers between before and after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Public Health, run by Pole Sante Grace de Dieu 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of knowledge improvement between before and after the intervention (time frame: 1 year). 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 31 May 2025.