NCT05163678

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 29, 2022

Status Verified

November 1, 2021

Enrollment Period

11 months

First QC Date

November 17, 2021

Last Update Submit

March 14, 2022

Conditions

Psychological Distress

Keywords

psychicearly treatmentAdolescent and young adultscohort follow upepidemiology

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • The futur of young people taken care of in the "Relais"

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

  • Satisfaction of subjects and his parents

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

Study Arms (1)

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

monitoring naturalistic of cohortOTHER

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

patient group

Eligibility Criteria

Age11 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Relais - Centre Adour

Aire-sur-l'Adour, 40800, France

NOT YET RECRUITING

Relais 77

Neufmoutiers-en-Brie, 77000, France

RECRUITING

Relais 93 - Sceaux

Sceaux, 92330, France

RECRUITING

Study Officials

  • Nathalie Godart, PU-PH

    Fondation Santé des Étudiants de France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Godart, PU-PH

CONTACT

0145894339nathalie.godart@fsef.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2021

First Posted

December 20, 2021

Study Start

January 1, 2022

Primary Completion

December 1, 2022

Study Completion

June 1, 2023

Last Updated

March 29, 2022

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)