Mental Health and Sexuality in Adolescents and Young Adults

Mental Health Issue Clinical Trial

— SEX-T-ADO  

Official title:

Mental Health and Sexuality in Adolescents and Young Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05316948
• Other study ID #: 2021-A03080-41
• Status: Not yet recruiting
• Start date: September 2022
• Est. completion date: November 2024

Study information

• Verified date: March 2022
• Source: Fondation Santé des Étudiants de France
• Contact: Anaïs Foussier, IDE
• Phone: 02 44 55 20 81
• Email: anais.foussier[@]fsef.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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 ).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 770
• Est. completion date: November 2024
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Adolescent Behavior
• Mental Disorders
• Mental Health Issue
• Problem Behavior
• Psychiatric Disorder

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Santé des Étudiants de France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	self-questionnaire (T0 = within three months of the opening of the center)
Secondary	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	self-questionnaire (T0 = within three months of the opening of the center)
Secondary	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.	self-questionnaire after the team training (T2 = 1 year)