Mental Health IssueMGIntegrADONCT07186335
Effectiveness of Promoting the Role of General Practitioners in a Mental Health Care System Integrated With Primary Care in Adolescence, According to the World Health Organization Definition
An observational study of Mental Health Issue and Adolescent Behavior, run by Fondation Santé des Étudiants de France.
Trial summary
MG-integr-ADO aims to create and evaluate in France, a system of integrated mental health care in primary care for adolescents with mental illness. The objective is to show that an intervention promoting the role of the general practitioner in the continuity of mental health care for young people with a team of… Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Mental Health Issue, Adolescent Behavior
- What is being tested?
- self-questionnaire
- How many people
- 1,400 participants
- Where
- No sites listed yet
- Study dates
- 9 Dec 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Young people aged 11-25 who have consulted the FSEF's Relais services, parents of these young people, Relais professionals, general practitioners
Who may be able to join
- Young adults aged 11-25 suffering from mental health issues
- Living in the relevant health region
- Attending Relais d'Ile-de-France centers (75, 77, 92, 93) alone or accompanied by someone
Who cannot join
- Young people outside the 11-25 age group - Parents and children who do not speak French or cannot read or write.
- Refusal to participate
- Young people in crisis situations requiring immediate hospitalization without care at Le Relais.
About this study
MG-integr-ADO aims to create and evaluate in France, a system of integrated mental health care in primary care for adolescents with mental illness.
The objective is to show that an intervention promoting the role of the general practitioner in the continuity of mental health care for young people with a team of "Indicated primary preventive interventions" (Relay) increases the rate of patients for whom the general practitioner has been contacted (presence of at least one contact with the general practitioner of the adolescent whether by telephone, mail or email, traced in the file) between the beginning and the end of care
Read the detailed description
Non-interventional multicenter prospective mixed study
Research process in 3 phases:
- multi-method inventory : a : Systematic review of the international literature on integrated mental health systems in primary care (done), b : Quantitative component evaluating the effective number of contacts of the general practitioner (front) in the Relays, c : Qualitative section on the Relay-general practitioner link (Interviews with Relay Professionals, GPs, patients)
- construction and deployment of the intervention to create the integrated system
- after the intervention, evaluation of its effect (number of general practitioners contacted, evolution at 6 months of adolescents treated: somatic and psychic state, unscheduled care, satisfaction)
- Conditions
- Mental Health Issue, Adolescent Behavior
- Being tested
- self-questionnaire
- Keywords
- teenagers and young adults, general practitioner
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-questionnaireOther
Quantitative survey with self-administered questionnaire offered to all patients
What is being measured
The primary outcome is the main question the study is designed to answer.
comparaison
The percentage of young people for whom the general practitioner was contacted between the start (known as T0) and the end of care (known as T1), as reported by the young person.
[Time Frame: To the inclusion of young people and in the End of care (care between 6 months to 1 year)]
Measured: self-questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start9 Dec 2025 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Santé des Étudiants de France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186335
- Sponsor's protocol ID
- 2023-A00883-42
- Acronym
- MGIntegrADO
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 22 Sep 2025
- 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 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Promoting the Role of General Practitioners in a Mental Health Care System Integrated With Primary Care in Adolescence, According to the World Health Organization Definition
- ClinicalTrials.gov ID
- NCT07186335
- Acronym / sponsor ID
- MGIntegrADO / 2023-A00883-42
- Conditions
- Mental Health Issue, Adolescent Behavior
- Keywords
- teenagers and young adults, general practitioner
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Fondation Santé des Étudiants de FranceUniversity, hospital or other
- Study start
- 9 Dec 2025 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Sep 2025 (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.
MG-integr-ADO aims to create and evaluate in France, a system of integrated mental health care in primary care for adolescents with mental illness.
The objective is to show that an intervention promoting the role of the general practitioner in the continuity of mental health care for young people with a team of "Indicated primary preventive interventions" (Relay) increases the rate of patients for whom the general practitioner has been contacted (presence of at least one contact with the general practitioner of the adolescent whether by telephone, mail or email, traced in the file) between the beginning and the end of care
Detailed description
Non-interventional multicenter prospective mixed study
Research process in 3 phases:
- multi-method inventory : a : Systematic review of the international literature on integrated mental health systems in primary care (done), b : Quantitative component evaluating the effective number of contacts of the general practitioner (front) in the Relays, c : Qualitative section on the Relay-general practitioner link (Interviews with Relay Professionals, GPs, patients)
- construction and deployment of the intervention to create the integrated system
- after the intervention, evaluation of its effect (number of general practitioners contacted, evolution at 6 months of adolescents treated: somatic and psychic state, unscheduled care, satisfaction)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Young people aged 11-25 who have consulted the FSEF's Relais services, parents of these young people, Relais professionals, general practitioners
Key inclusion criteria (3 listed)
- Young adults aged 11-25 suffering from mental health issues
- Living in the relevant health region
- Attending Relais d'Ile-de-France centers (75, 77, 92, 93) alone or accompanied by someone
Key exclusion criteria (3 listed)
- Young people outside the 11-25 age group - Parents and children who do not speak French or cannot read or write.
- Refusal to participate
- Young people in crisis situations requiring immediate hospitalization without care at Le Relais.
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 |
|---|---|---|
| self-questionnaireQuantitative survey with self-administered questionnaire offered to all patients | Other | – |
Primary outcome
comparaison
Time frame: self-questionnaire
The percentage of young people for whom the general practitioner was contacted between the start (known as T0) and the end of care (known as T1), as reported by the young person. [Time Frame: To the inclusion of young people and in the End of care (care between 6 months to 1 year)]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Issue and Adolescent Behavior, run by Fondation Santé des Étudiants de 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 3 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: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
comparaison (time frame: self-questionnaire). 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 22 Sep 2025.