NCT05225441

Brief Summary

For the clinical component: Describe the young people hospitalised in residential care at the FSEF, in particular through vulnerability factors and their psychosocial repercussions (school level, repetition, intensity of symptoms, irritability, nervousness, substance use (cannabis, alcohol, tobacco), social relationships, family relationships, well-being, level of health literacy, learning disorders)) and to compare them with young people from the general school population. For the epidemiological aspect: To study the construct validity of the EnCLASS questions aiming to characterize handicap situations in the general school population in both a population in situation of psychic handicap and of somatic handicap.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
598

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2022

Completed
Last Updated

July 26, 2022

Status Verified

December 1, 2021

Enrollment Period

4 months

First QC Date

January 17, 2022

Last Update Submit

July 22, 2022

Conditions

Keywords

clinical epidemiologySubstance use and abusePsychiatric symptomsSocial disabilitiesHealth literacy

Outcome Measures

Primary Outcomes (1)

  • description of the study population

    Describe the young people taken into "soins étude" at the FSEF for a psychiatric pathology or for a somatic pathology, in particular through characteristic vulnerability factors and their psychosocial repercussions (school level, repetition, intensity of symptoms, irritability, nervousness, consumption of toxicants (cannabis, alcohol, tobacco), ease of having friends, quality of family relationships, well-being, level of health literacy, "dys" disorders)) and comparison with young people from the general school population. This description and comparison will be carried out thanks to the answers of the young people to the questionnaire of the national survey (identical questionnaire for the population of the FSEF and the national population).

    inclusion

Secondary Outcomes (2)

  • comparison

    inclusion

  • frequency

    inclusion

Eligibility Criteria

Age11 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All young people hospitalized in care-study in the 13 clinics in the FSEF (i.e. around 1,500) over the period from March to June 2022.

You may qualify if:

  • Student cared for in college and high school studies in the 13 clinics of the FSEF,
  • From 11 years old,
  • Non-opposition of the student to his participation in the study and to the use of his data (and of their parents for minor students).

You may not qualify if:

  • Student opposition to participating in the study (or their parents for underage students).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Godart Nathalie

Paris, 75014, France

Location

MeSH Terms

Conditions

Mental DisordersMedically Unexplained SymptomsWounds and InjuriesSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsChemically-Induced Disorders

Study Officials

  • Nathalie Godart

    Fondation Santé des Etudiants de France

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 17, 2022

First Posted

February 4, 2022

Study Start

March 1, 2022

Primary Completion

June 24, 2022

Study Completion

June 24, 2022

Last Updated

July 26, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations