Psychiatric DisorderEnCLASS-FSEFNCT05225441
National Investigation in College and High School Among Adolescents on Health and Substances at the FSEF
An observational study of Psychiatric Disorder and Somatic Symptom, run by Fondation Santé des Étudiants de France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 20 years
- Conditions the study is for
- Psychiatric Disorder, Somatic Symptom, Traumatic Injury
- How many people
- 598 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 24 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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).
Who cannot join
- Student opposition to participating in the study (or their parents for underage students).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
Residential care in psychiatry in France, although recommended by the HAS and widely implemented, have been little evaluated In France, the residential care of the FSEF called "soins-études" have long been recognized as contributors to psychosocial rehabilitation. They hospitalize young people with mental and physical disabilities. They allow the continuation of hospital care associated with the resumption of schooling and the implementation of a training project integrated into the individualized care plan. Each year, around 1 500 young people are admitted to full-time hospitalization for "soins-études" in psychiatry or medicine (follow-up care and rehabilitation) within the FSEF. They benefit from comprehensive care, adapted to their needs, including care, maintenance or resumption of schooling and social reintegration in a peer group. A recent review of the literature showed that the provision of "soins-études" in psychiatry allows clinical improvement in nearly two-thirds of between more than 5 years after admissionit, and the resumption of schooling and a training project. The young people admitted at the FSEF generally have been receiving care for more than 3 years for chronic psychiatric disorders. Despite frequent school delays or periods of dropping out of school, a large majority of them had a school activity during the care.
However, it appears from this review that the characteristics of the young people received have never been compared with those of students in a traditional education course. Characterizing this population meets a need, as well as a strong institutional demand (FSEF, funders and national education).
The EnCLASS-FSEF survey will be rolled out with the national EnCLASS methodology in all the annexes of the National Education schools integrated into the 13 FSEF care-study clinics (therefore on the total population in care-studies of the FSEF educated in secondary school) - making it possible to describe and compare the patients treated in care studies with the general school population.
- Conditions
- Psychiatric Disorder, Somatic Symptom, Traumatic Injury
- Keywords
- clinical epidemiology, Substance use and abuse, Psychiatric symptoms, Social disabilities, Health literacy
- Medical subject headings
- Mental Disorders, Medically Unexplained Symptoms, Wounds and Injuries, Substance-Related Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: inclusion
Secondary outcomes (2)
comparison
Compare the levels of psychological symtoms the FSEF population to the general population (response of young people to specific questions on the subject in the national survey questionnaire).
Measured: inclusion
frequency
Frequency of various psychiatric disorders within the FSEF population and description of psychotropic treatments received. Data will be collected both through young people's responses to specific questions aimed at the FSEF population and both from the participants' medical records.
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Mar 2022
- Primary completion24 Jun 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Santé des Étudiants de France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Godart, Study director, Fondation Santé des Etudiants de France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225441
- Sponsor's protocol ID
- 2021-A02640-41
- Acronym
- EnCLASS-FSEF
- Status last verified
- Dec 2021
- First submitted
- 17 Jan 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Investigation in College and High School Among Adolescents on Health and Substances at the FSEF
- ClinicalTrials.gov ID
- NCT05225441
- Acronym / sponsor ID
- EnCLASS-FSEF / 2021-A02640-41
- Conditions
- Psychiatric Disorder, Somatic Symptom, Traumatic Injury
- Keywords
- clinical epidemiology, Substance use and abuse, Psychiatric symptoms, Social disabilities, Health literacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- Fondation Santé des Étudiants de FranceUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Residential care in psychiatry in France, although recommended by the HAS and widely implemented, have been little evaluated In France, the residential care of the FSEF called "soins-études" have long been recognized as contributors to psychosocial rehabilitation. They hospitalize young people with mental and physical disabilities. They allow the continuation of hospital care associated with the resumption of schooling and the implementation of a training project integrated into the individualized care plan. Each year, around 1 500 young people are admitted to full-time hospitalization for "soins-études" in psychiatry or medicine (follow-up care and rehabilitation) within the FSEF. They benefit from comprehensive care, adapted to their needs, including care, maintenance or resumption of schooling and social reintegration in a peer group. A recent review of the literature showed that the provision of "soins-études" in psychiatry allows clinical improvement in nearly two-thirds of between more than 5 years after admissionit, and the resumption of schooling and a training project. The young people admitted at the FSEF generally have been receiving care for more than 3 years for chronic psychiatric disorders. Despite frequent school delays or periods of dropping out of school, a large majority of them had a school activity during the care.
However, it appears from this review that the characteristics of the young people received have never been compared with those of students in a traditional education course. Characterizing this population meets a need, as well as a strong institutional demand (FSEF, funders and national education).
The EnCLASS-FSEF survey will be rolled out with the national EnCLASS methodology in all the annexes of the National Education schools integrated into the 13 FSEF care-study clinics (therefore on the total population in care-studies of the FSEF educated in secondary school) - making it possible to describe and compare the patients treated in care studies with the general school population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Student opposition to participating in the study (or their parents for underage students).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
description of the study population
Time frame: inclusion
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).
2 secondary outcomes
comparison
Time frame: inclusion
frequency
Time frame: inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Godart study director
Fondation Santé des Etudiants de France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorder and Somatic Symptom, run by Fondation Santé des Étudiants de France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
description of the study population (time frame: inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.