Clinical trial NCT05316948: Mental Health and Sexuality in Adolescents and Young Adults
Official title: Mental Health and Sexuality in Adolescents and Young Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psychiatric Disorder
Adolescent Behavior
Mental Health Issue
Keywords: psychotropic treatment
sexuality
teenagers and young adults
Lead sponsor: Fondation Santé des Étudiants de France
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 770
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All young people hospitalized in the 13 structures of the FSEF aged 15 or over.

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 ).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Comparison
timeFrame: self-questionnaire after the team training (T2 = 1 year)
Secondary outcomes:
measure: Description
timeFrame: self-questionnaire (T0 = within three months of the opening of the center)
measure: Comparison
timeFrame: self-questionnaire (T0 = within three months of the opening of the center)
measure: Comparison
timeFrame: self-questionnaire after the team training (T2 = 1 year)
Other outcomes:
Locations:
city: Vence
country: France
facility: Clinique FSEF Vence
state: Alpes Maritimes
city: Grenoble
country: France
facility: Clinique FSEF Grenoble La Tronche
state: Auvergne-Rhône-Alpes
city: Rennes
country: France
facility: Clinique FSEF Rennes-Beaulieu
state: Bretagne
city: Bouffémont
country: France
facility: Clinique FSEF Bouffémont
state: Ile De France
city: Neufmoutiers-en-Brie
country: France
facility: Clinique FSEF Neufmoutiers-en-Brie
state: Ile De France
city: Paris
country: France
facility: Clinique FSEF Paris 13
state: Ile De France
city: Paris
country: France
facility: Clinique FSEF Paris 16
state: Ile De France
city: Sceaux
country: France
facility: Clinique FSEF Sceaux
state: Ile De France
city: Aire-sur-l'Adour
country: France
facility: Clinique FSEF Aire sur l'Adour
state: Landes
city: Vitry-le-François
country: France
facility: Clinique FSEF Vitry-le-François
state: Marne
city: Villeneuve d'Ascq
country: France
facility: Clinique FSEF Villeneuve d'Ascq
state: Nord
city: Sablé-sur-Sarthe
country: France
facility: Clinique FSEF Sablé-sur-Sarthe
state: Pays De La Loire
Study officials:
References: