NCT05316948

Brief Summary

According to the World Health Organization (WHO), "Sexual health is a state of physical, emotional, mental and social well-being in relation to sexuality, not merely the absence of disease, dysfunction or of infirmity. Sexual health requires a positive and respectful approach to sexuality and sexual relationships \[...\]". The main objective is to show that a training intervention intended for psychiatric care teams and targeted on the question of the impact of psychiatric disorders and psychotropic drugs on the sexuality of young people, increases the proportion of young people with whom the question of sexual health is discussed (in connection with psychiatric disorders and, if applicable, with the taking of psychotropic treatment, while they are hospitalized for a psychiatric disorder in the clinics of the FSEF and receive, or not, psychotropic treatment ).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
770

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

March 17, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

February 27, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

2.7 years

First QC Date

March 17, 2022

Last Update Submit

September 4, 2025

Conditions

Psychiatric DisorderAdolescent BehaviorMental Health Issue

Keywords

psychotropic treatmentsexualityteenagers and young adults

Outcome Measures

Primary Outcomes (1)

  • Comparison

    To show that a training intervention intended for the healthcare team makes it possible to increase the proportion of young people with whom the question of sexual health has been approached, in connection with psychiatric disorders and, if necessary, with taking treatment psychotropics; while they are hospitalized for a psychiatric disorder in the clinics of the FSEF and receive, or not, a psychotropic treatment.

    self-questionnaire after the team training (T2 = 1 year)

Secondary Outcomes (3)

  • Description

    self-questionnaire (T0 = within three months of the opening of the center)

  • Comparison

    self-questionnaire (T0 = within three months of the opening of the center)

  • Comparison

    self-questionnaire after the team training (T2 = 1 year)

Interventions

self-questionnaireOTHER

Quantitative survey with self-administered questionnaire offered to all patients attending psychiatry study care during the month of the assessment.

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All young people hospitalized in the 13 structures of the FSEF aged 15 or over.

You may qualify if:

  • Young people hospitalized in psychiatric care-studies in one of the establishments of the FSEF,
  • Age ≥ 15 years (age of sexual majority),
  • Receiving or not a psychotropic treatment,
  • No opposition to participation (or parents for minors) in the study and use of data

You may not qualify if:

  • Refusal to participate
  • Patient under 15 years old
  • Need for emergency care (medicine or psychiatry).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Clinique FSEF Vence

Vence, Alpes Maritimes, 06140, France

RECRUITING

Clinique FSEF Grenoble La Tronche

Grenoble, Auvergne-Rhône-Alpes, 38700, France

RECRUITING

Clinique FSEF Rennes-Beaulieu

Rennes, Brittany Region, 35700, France

RECRUITING

Clinique FSEF Aire sur l'Adour

Aire-sur-l'Adour, Landes, 40800, France

RECRUITING

Clinique FSEF Vitry-le-François

Vitry-le-François, Marne, 51300, France

RECRUITING

Clinique FSEF Villeneuve d'Ascq

Villeneuve-d'Ascq, Nord, 59650, France

RECRUITING

Clinique FSEF Sablé-sur-Sarthe

Sablé-sur-Sarthe, Pays de la Loire Region, 72300, France

RECRUITING

Clinique FSEF Bouffémont

Bouffémont, Île-de-France Region, 95570, France

RECRUITING

Clinique FSEF Neufmoutiers-en-Brie

Neufmoutiers-en-Brie, Île-de-France Region, 77610, France

RECRUITING

Clinique FSEF Paris 13

Paris, Île-de-France Region, 75013, France

RECRUITING

Clinique FSEF Paris 16

Paris, Île-de-France Region, 75016, France

RECRUITING

Clinique FSEF Sceaux

Sceaux, Île-de-France Region, 92330, France

RECRUITING

MeSH Terms

Conditions

Mental DisordersAdolescent BehaviorSexuality

Condition Hierarchy (Ancestors)

BehaviorSexual Behavior

Central Study Contacts

Anaïs Foussier, IDE

CONTACT

+33 2 44 55 20 81anais.foussier@fsef.net

Said SEDFI

CONTACT

+33 1 45 89 43 39said.sedfi@fsef.net

Study Design

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

Study Record Dates

First Submitted

March 17, 2022

First Posted

April 7, 2022

Study Start

February 27, 2023

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(12)