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RecruitingNCT05316948SEX-T-ADOUpdated Sep 5, 2025

Mental Health and Sexuality in Adolescents and Young Adults

An observational study in Psychiatric Disorder, Adolescent Behavior and Mental Health Issue, sponsored by Fondation Santé des Étudiants de France. Recruiting at 12 sites in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2025-09-05.

Sponsored by Fondation Santé des Étudiants de France · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
770
Ages
15 Years and older
Sex
All
01

Study 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 ).

Read the detailed description

Non-interventional multicenter prospective mixed study (quantitative and qualitative).

Research process in 3 phases:

  1. Inventory with a mixed method evaluation (quantitative survey and qualitative survey),

    • Step 1: quantitative survey with self-administered questionnaire offered to all patients attending psychiatric study care during the month of the assessment.
    • Step 2: qualitative survey of young people and caregivers.
  2. Design and implementation of an intervention adapted to the needs of the field (training for caregivers and tools for young people).

    • Step 3: implementation of training programs for professionals based on data from phase 1 and preparation for interventions for young people.
    • Step 4: Interventions (interventions with young people in groups and individually).
  3. Reassessment after the deployment of the intervention - Step 5: Finally, the quantitative survey of stage 1 with a self-questionnaire offered to all patients present in psychiatric care-study will be repeated during one month of the evaluation in order to measure the impact of the action taken.
02

Conditions studied

  • Psychiatric Disorder
  • Adolescent Behavior
  • Mental Health Issue

Keywords

  • psychotropic treatment
  • sexuality
  • teenagers and young adults
03

In context

Mental Disorders

1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.

This study's planned enrollment of 770 is above the median of 220 across 389 observational studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Fondation Santé des Étudiants de France is the lead sponsor of 9 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Refusal to participate
  • Patient under 15 years old
  • Need for emergency care (medicine or psychiatry).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
770 participants (estimated)
Patient registry
No

Interventions

  • Otherself-questionnaire

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

06

What researchers measure

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.

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

Secondary outcomes

  1. Description

    Describe the sexuality of adolescents and young adults hospitalized in a psychiatric establishment within the FSEF with quantitative survey with self-questionnaire exploring sexual adverse effects

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

  2. Comparison

    To compare the sexual life of patients hospitalized at the FSEF for a psychiatric illness - according to whether or not they receive psychotropic treatment with quantitative survey with self-questionnaire exploring sexual adverse effects

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

  3. Comparison

    To compare the perceived impact of psychiatric disorders and psychotropic treatments on patients' sexual satisfaction measured by a Likert scale of sexual satisfaction (rated from 1 to 5 with 1 equal to very satisfied and 5 to very dissatisfied) before and after intervention.

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

07

Study locations

12 of 12 sites recruiting
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2023 (actual). Primary completion is estimated for Nov 2025, 33 months after the start.

Of 149 non-industry observational studies under Mental Disorders, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 77. This study's planned 33 months is below that.

Counting every sponsor, half of 156 studies reached it within 37 months; a quarter within 13 and three quarters within 77.

Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 17, 2022
First posted
Apr 7, 2022
StartActual
Feb 27, 2023
Primary completionEst.
Nov 2025
CompletionEst.
Nov 2025
Last update
Sep 5, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05316948
Lead sponsor
Fondation Santé des Étudiants de France
Responsible party
Sponsor
First posted
Apr 7, 2022
Start date
Feb 27, 2023
Primary completion
Nov 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Sep 5, 2025

Study contacts

Anaïs Foussier, IDE
Contact
anais.foussier@fsef.net
+33 2 44 55 20 81
Said SEDFI
Contact
said.sedfi@fsef.net
+33 1 45 89 43 39

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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