Evaluation of the Future of Adolescents and Young Adults Received in an Early Care System

Psychological Distress Clinical Trial

— ReFSEF  

Official title:

Evaluation of the Future of Adolescents and Young Adults Received in an Early Care System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05163678
• Other study ID #: FSEF
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: June 2023

Study information

• Verified date: November 2021
• Source: Fondation Santé des Étudiants de France
• Contact: Nathalie Godart, PU-PH
• Phone: 0145894339
• Email: nathalie.godart[@]fsef.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective clinical epidemiology study based on the naturalistic follow-up of a cohort of 1 500 young people aged 11 to 25 presenting consecutively over the course of one year at the Relais d'Ile de France.

Young people will be assessed on entry into the system (T0), at the end of the follow-up (T1) and 6 months after the end of the follow-up (T6).

Description:

Psychic suffering is very common among young people; a public health issue in France is to improve its early identification and treatment. To this end, the Fondation Santé des Etudiants de France (FSEF) has developed ambulatory systems in France called "Relais Collégiens-Lycéens-Etudiants" offering adolescents and young adults a reception, evaluation and support or a quick referral.

The FSEF Relay system allows a wide range of subjects to benefit from rapid support for a situation of mental suffering, which specialized care structures cannot do. In fact, first of all, if the school teams and the entourage are not made aware of the need to be attentive to psychological suffering, it is not detected, then when it is, most of these young people are not. not addressed out of reluctance from those around them or from the young person himself who refuse to go to psychiatric care experienced as stigmatizing; then, when young people are referred to care structures, consultation times are unsuitable (saturated structures) while these young people need a rapid response. The impact of early detection systems in adolescence has been little studied, this research proposes to initiate such an approach on a large panel of young people from a systematic evaluation, by evaluating the future in the short and medium term.

This research proposes to assess the impact of these devices. T his is a prospective clinical epidemiology study based on the naturalistic follow-up of a cohort of 1,500 young people aged 11 to 25 presenting consecutively over the course of one year at the 5 Relais d'Ile de France. Young people will be assessed on entry into the system (T0), at the end of the follow-up (T1) and 6 months after the end of the follow-up (T6). The data collected will be:

• The state of health (including mental health, somatic health and drug consumption), lifestyle and education and social adaptation through clinical assessment and self-questionnaires completed by young people:

• The clinical assessment includes the following elements: the severity of the psychological suffering (CGI, Global Clinical Impression), the psychosocial impact (SOFAS, Social and Occupational Functioning Assessment Scale) and the diagnosis of mental disorder according to the ICD 10 (International Classification) 10th Revision) when relevant.

• The self-questionnaires assess psychological suffering (K10, Kessler scale 10 items), social functioning (WSAS, Work Social Adjustment Scale) as well as satisfaction with the care provided (CSQ-8, Client Satisfaction Questionnaire 8 items, and Likert scale, at T1 and T6).

• The EDGAR grid (Interview, Approach, Group, Support, Meeting) to quantify the care offered at the Relais and their cost.

• The orientation that may be offered following this support

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 25 Years

Eligibility

Inclusion Criteria:

• All adolescents, young adults in the age group 11-25 years,

• Presenting ill-being or psychological suffering, living in the health area concerned,

• Arriving alone or accompagniead at the "Realis" during the sudy period

• Agreeing to participate.

Exclusion Criteria:

• Young people outside the 11-25 age group,

• Parents and children who do not speak French or who cannot read or write.

• Young people in crisis situations requiring immediate hospitalization without consultation at the Relais.

• Refusal to participate

Related Conditions & MeSH terms

• Psychological Distress

Intervention

Other:
• monitoring naturalistic of cohort
Assessment at the start of care in the "Relais" (T0), at the end (T1) and 6 months later (T6).

Locations

Country	Name	City	State
France	Relais - Centre Adour	Aire-sur-l'Adour
France	Relais 77	Neufmoutiers en Brie
France	Relais 93 - Sceaux	Sceaux

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Santé des Étudiants de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detailed description of the socio-demographic characteristics of the population hosted in the Relais	Socio-demographic description of the population (Sex, age,nationality, civil and family situation, education)	To the inclusion of young people
Primary	Detailed description of the socio-demographic characteristics of the population hosted in the Relais	By whom it is addressed, the reasons for addressing it, the level of mental suffering, the severity of the situation (diagnostic).	To the inclusion of young people
Primary	Detailed description of the socio-demographic characteristics of the population hosted in the Relais	The psycho-social impact of the difficulties will also be assessed, also including data on the school career and the types and intensity of care generated, the duration of the follow-up, the diagnosis made and the orientation proposed, if applicable.	To the inclusion of young people
Secondary	The futur of young people taken care of in the "Relais"	Assessment of the fate at the end of the care and at 6 months, of adolescents and young adults received at least once as part of a consultation in a Relay. The criteria will relate to the assessment at the end of treatment and then at 6 months there of, in comparison with the initial state. These comparisons will relate to the level of psychological suffering, the psycho-social impact, and the implementation of the recommended care.	End of care (care between 6 months to 1 year) and 6 months after end of follow-up
Secondary	Satisfaction of subjects and his parents	Evaluate the level of satisfaction by means of a questionnaire of the subject and his parents with regard to the intervention and the orientation within the framework of the Relay schemes at the end of the care and at 6 months.	End of care (care between 6 months to 1 year) and 6 months after end of follow-up