- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05316948
Mental Health and Sexuality in Adolescents and Young Adults (SEX-T-ADO)
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 ).
Study Overview
Status
Intervention / 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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Anaïs Foussier, IDE
- Phone Number: +33 2 44 55 20 81
- Email: anais.foussier@fsef.net
Study Contact Backup
- Name: Said SEDFI
- Phone Number: +33 1 45 89 43 39
- Email: said.sedfi@fsef.net
Study Locations
-
-
Alpes Maritimes
-
Vence, Alpes Maritimes, France, 06140
- Recruiting
- Clinique FSEF Vence
-
-
Auvergne-Rhône-Alpes
-
Grenoble, Auvergne-Rhône-Alpes, France, 38700
- Recruiting
- Clinique FSEF Grenoble La Tronche
-
-
Brittany Region
-
Rennes, Brittany Region, France, 35700
- Recruiting
- Clinique FSEF Rennes-Beaulieu
-
-
Landes
-
Aire-sur-l'Adour, Landes, France, 40800
- Recruiting
- Clinique FSEF Aire sur l'Adour
-
-
Marne
-
Vitry-le-François, Marne, France, 51300
- Recruiting
- Clinique FSEF Vitry-le-François
-
-
Nord
-
Villeneuve-d'Ascq, Nord, France, 59650
- Recruiting
- Clinique FSEF Villeneuve d'Ascq
-
-
Pays de la Loire Region
-
Sablé-sur-Sarthe, Pays de la Loire Region, France, 72300
- Recruiting
- Clinique FSEF Sablé-sur-Sarthe
-
-
Île-de-France Region
-
Bouffémont, Île-de-France Region, France, 95570
- Recruiting
- Clinique FSEF Bouffémont
-
Neufmoutiers-en-Brie, Île-de-France Region, France, 77610
- Recruiting
- Clinique FSEF Neufmoutiers-en-Brie
-
Paris, Île-de-France Region, France, 75013
- Recruiting
- Clinique FSEF Paris 13
-
Paris, Île-de-France Region, France, 75016
- Recruiting
- Clinique FSEF Paris 16
-
Sceaux, Île-de-France Region, France, 92330
- Recruiting
- Clinique FSEF Sceaux
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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:
- Refusal to participate
- Patient under 15 years old
- Need for emergency care (medicine or psychiatry).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
self-questionnaire after the team training (T2 = 1 year)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Description
Time Frame: self-questionnaire (T0 = within three months of the opening of the center)
|
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
|
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)
|
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
|
self-questionnaire (T0 = within three months of the opening of the center)
|
|
Comparison
Time Frame: self-questionnaire after the team training (T2 = 1 year)
|
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.
|
self-questionnaire after the team training (T2 = 1 year)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-A03080-41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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