NCT06400758

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 6, 2024

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

April 30, 2024

Last Update Submit

May 27, 2025

Conditions

Keywords

preventionsexual healthstudents

Outcome Measures

Primary Outcomes (1)

  • Rate of knowledge improvement between before and after the intervention

    the accuracy of correct answers between before and after intervention

    1 year

Interventions

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.

Eligibility Criteria

Age15 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • school students in the 2023-2024 school year

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PSLA GDD

Caen, 14000, France

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2024

First Posted

May 6, 2024

Study Start

March 14, 2024

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations