Psychiatric DisorderSEX-T-ADONCT05316948
Mental Health and Sexuality in Adolescents and Young Adults
An observational study of Psychiatric Disorder and Adolescent Behavior, run by Fondation Santé des Étudiants de France at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Psychiatric Disorder, Adolescent Behavior, Mental Health Issue
- What is being tested?
- self-questionnaire
- How many people
- 770 participants
- Where
- 12 sitesFrance
- Study dates
- 27 Feb 2023to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All young people hospitalized in the 13 structures of the FSEF aged 15 or over.
Who may be able to join
- 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
Who cannot join
- Refusal to participate
- Patient under 15 years old
- Need for emergency care (medicine or psychiatry).
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites, 12 recruiting
- Recruiting
Clinique FSEF Aire sur l'Adour
Aire-sur-l'Adour, Landes, 40800
- Recruiting
Clinique FSEF Bouffémont
Bouffémont, Île-de-France Region, 95570
- Recruiting
Clinique FSEF Grenoble La Tronche
Grenoble, Auvergne-Rhône-Alpes, 38700
- Recruiting
Clinique FSEF Neufmoutiers-en-Brie
Neufmoutiers-en-Brie, Île-de-France Region, 77610
- Recruiting
Clinique FSEF Paris 13
Paris, Île-de-France Region, 75013
- Recruiting
Clinique FSEF Paris 16
Paris, Île-de-France Region, 75016
- Recruiting
Clinique FSEF Rennes-Beaulieu
Rennes, Brittany Region, 35700
- Recruiting
Clinique FSEF Sablé-sur-Sarthe
Sablé-sur-Sarthe, Pays de la Loire Region, 72300
- Recruiting
Clinique FSEF Sceaux
Sceaux, Île-de-France Region, 92330
- Recruiting
Clinique FSEF Vence
Vence, Alpes Maritimes, 06140
- Recruiting
Clinique FSEF Villeneuve d'Ascq
Villeneuve-d'Ascq, Nord, 59650
- Recruiting
Clinique FSEF Vitry-le-François
Vitry-le-François, Marne, 51300
About this study
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:
- 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.
- 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).
- 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.
- Being tested
- self-questionnaire
- Keywords
- psychotropic treatment, sexuality, teenagers and young adults
- Medical subject headings
- Mental Disorders, Adolescent Behavior, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-questionnaireOther
Quantitative survey with self-administered questionnaire offered to all patients attending psychiatry study care during the month of the assessment.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: self-questionnaire after the team training (T2 = 1 year)
Secondary outcomes (3)
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
Measured: self-questionnaire (T0 = within three months of the opening of the center)
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
Measured: self-questionnaire (T0 = within three months of the opening of the center)
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.
Measured: self-questionnaire after the team training (T2 = 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start27 Feb 2023
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 770 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Santé des Étudiants de France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316948
- Sponsor's protocol ID
- 2021-A03080-41
- Acronym
- SEX-T-ADO
- Status last verified
- Aug 2025
- First submitted
- 17 Mar 2022
- Last updated
- 5 Sep 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health and Sexuality in Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT05316948
- Acronym / sponsor ID
- SEX-T-ADO / 2021-A03080-41
- Keywords
- psychotropic treatment, sexuality, teenagers and young adults
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 770 participants (estimated)
- Lead sponsor
- Fondation Santé des Étudiants de FranceUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 7 Apr 2022 (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.
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 ).
Detailed description
Non-interventional multicenter prospective mixed study (quantitative and qualitative).
Research process in 3 phases:
- 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.
- 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).
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All young people hospitalized in the 13 structures of the FSEF aged 15 or over.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Refusal to participate
- Patient under 15 years old
- Need for emergency care (medicine or psychiatry).
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 |
|---|---|---|
| self-questionnaireQuantitative survey with self-administered questionnaire offered to all patients attending psychiatry study care during the month of the assessment. | Other | – |
Primary outcome
Comparison
Time frame: self-questionnaire after the team training (T2 = 1 year)
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.
3 secondary outcomes
Description
Time frame: self-questionnaire (T0 = within three months of the opening of the center)
Comparison
Time frame: self-questionnaire (T0 = within three months of the opening of the center)
Comparison
Time frame: self-questionnaire after the team training (T2 = 1 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorder and Adolescent Behavior, run by Fondation Santé des Étudiants de France at 12 sites 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anaïs Foussier, IDE (+33 2 44 55 20 81, anais.foussier@fsef.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison (time frame: self-questionnaire after the team training (T2 = 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 5 Sep 2025.