Psychological DistressReFSEFNCT05163678
Evaluation of the Future of Adolescents and Young Adults Received in an Early Care System
An observational study of Psychological Distress, run by Fondation Santé des Étudiants de France at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 11 to 25 years
- Conditions the study is for
- Psychological Distress
- What is being tested?
- monitoring naturalistic of cohort
- How many people
- 1,500 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Jan 2022to Jun 2023
- 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 25 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Not yet recruiting
Relais - Centre Adour
Aire-sur-l'Adour, 40800
Catherine Viginiat
- Recruiting
Relais 77
Neufmoutiers-en-Brie, 77000
Michele Simon
- Recruiting
Relais 93 - Sceaux
Sceaux, 92330
Nadege Dumas
About this study
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
- Conditions
- Psychological Distress
- Being tested
- monitoring naturalistic of cohort
- Keywords
- psychic, early treatment, Adolescent and young adults, cohort follow up, epidemiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monitoring naturalistic of cohortOther
Assessment at the start of care in the "Relais" (T0), at the end (T1) and 6 months later (T6).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: monitoring naturalistic of cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: 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.
Measured: To the inclusion of young people
Secondary outcomes (2)
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.
Measured: End of care (care between 6 months to 1 year) and 6 months after end of follow-up
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.
Measured: End of care (care between 6 months to 1 year) and 6 months after end of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start1 Jan 2022
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Santé des Étudiants de France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Godart, PU-PH, Principal investigator, Fondation Santé des Étudiants de France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163678
- Sponsor's protocol ID
- FSEF
- Acronym
- ReFSEF
- Status last verified
- Nov 2021
- First submitted
- 17 Nov 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- 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 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Future of Adolescents and Young Adults Received in an Early Care System
- ClinicalTrials.gov ID
- NCT05163678
- Acronym / sponsor ID
- ReFSEF / FSEF
- Conditions
- Psychological Distress
- Keywords
- psychic, early treatment, Adolescent and young adults, cohort follow up, epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Fondation Santé des Étudiants de FranceUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 20 Dec 2021 (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.
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).
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient group | – | Other: monitoring naturalistic of cohortAll 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). |
Who may qualify
- Ages
- 11 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| monitoring naturalistic of cohortAssessment at the start of care in the "Relais" (T0), at the end (T1) and 6 months later (T6). | Other | patient group |
Primary outcome
Detailed description of the socio-demographic characteristics of the population hosted in the Relais
Time frame: To the inclusion of young people
Socio-demographic description of the population (Sex, age,nationality, civil and family situation, education)
Detailed description of the socio-demographic characteristics of the population hosted in the Relais
Time frame: To the inclusion of young people
By whom it is addressed, the reasons for addressing it, the level of mental suffering, the severity of the situation (diagnostic).
Detailed description of the socio-demographic characteristics of the population hosted in the Relais
Time frame: To the inclusion of young people
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.
2 secondary outcomes
The futur of young people taken care of in the "Relais"
Time frame: End of care (care between 6 months to 1 year) and 6 months after end of follow-up
Satisfaction of subjects and his parents
Time frame: End of care (care between 6 months to 1 year) and 6 months after end of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 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, PU-PH principal investigator
Fondation Santé des Étudiants de France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Distress, run by Fondation Santé des Étudiants de France at 3 sites 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathalie Godart, PU-PH (0145894339, nathalie.godart@fsef.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detailed description of the socio-demographic characteristics of the population hosted in the Relais (time frame: To the inclusion of young people). The study lists 3 primary outcomes in all. 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 29 Mar 2022.