CClinicalTrials.gg
Status unknownNCT05163678ReFSEFUpdated Mar 29, 2022

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

An observational study in Psychological Distress, sponsored by Fondation Santé des Étudiants de France. Status unknown at 3 sites in France. Open to participants aged 11 Years to 25 Years. Per ClinicalTrials.gov, last updated 2022-03-29.

Sponsored by Fondation Santé des Étudiants de France · Observational

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
11 Years to 25 Years
Sex
All
01

Study 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).

Read the detailed 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
02

Conditions studied

  • Psychological Distress

Keywords

  • psychic
  • early treatment
  • Adolescent and young adults
  • cohort follow up
  • epidemiology
03

In context

Lead sponsor

Fondation Santé des Étudiants de France is the lead sponsor of 9 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

This study will focus on 1500 files of young people aged 11 to 25, received in consultation in the Relays over one year (average activity in recent years). Participation will be voluntary.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • patient group

    All adolescents or young adults presenting for a consultation in the FSEF "Relais" systems. They will be assessed upon entry into the device (T0), at the end of the follow-up (T1) and 6 months after the end of the follow-up (T6).

    Other: monitoring naturalistic of cohort

Interventions

  • Othermonitoring naturalistic of cohort

    Assessment at the start of care in the "Relais" (T0), at the end (T1) and 6 months later (T6).

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: To the inclusion of young people

  2. 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).

    Time frame: To the inclusion of young people

  3. 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.

    Time frame: To the inclusion of young people

Secondary outcomes

  1. 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.

    Time frame: End of care (care between 6 months to 1 year) and 6 months after end of follow-up

  2. 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.

    Time frame: End of care (care between 6 months to 1 year) and 6 months after end of follow-up

07

Study locations

2 of 3 sites recruiting
  • Relais - Centre Adour
    Aire-sur-l'Adour, 40800, France
    • Catherine Viginiat · Contact
    Not yet recruiting
  • Relais 77
    Neufmoutiers en Brie, 77000, France
    • Michele Simon · Contact
    Recruiting
  • Relais 93 - Sceaux
    Sceaux, 92330, France
    • Nadege Dumas · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05163678
Lead sponsor
Fondation Santé des Étudiants de France
Responsible party
Sponsor
First posted
Dec 20, 2021
Start date
Jan 1, 2022
Primary completion
Dec 2022 (estimated)
Completion
Jun 2023 (estimated)
Last update
Mar 29, 2022

Study contacts

Nathalie Godart, PU-PH
Contact
nathalie.godart@fsef.net
0145894339
Nathalie Godart, PU-PH
principal investigator · Fondation Santé des Étudiants de France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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