Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT07186335
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000294', 'term': 'Adolescent Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2025-09-15', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparaison', 'timeFrame': 'self-questionnaire', 'description': '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.\n\n\\[Time Frame: To the inclusion of young people and in the End of care (care between 6 months to 1 year)\\]'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['teenagers and young adults', 'general practitioner'], 'conditions': ['Mental Health Issue', 'Adolescent Behavior']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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', 'detailedDescription': 'Non-interventional multicenter prospective mixed study\n\nResearch process in 3 phases:\n\n1. multi-method inventory :\n\n 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)\n2. construction and deployment of the intervention to create the integrated system\n3. 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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Young people aged 11-25 who have consulted the FSEF's Relais services, parents of these young people, Relais professionals, general practitioners", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Young adults aged 11-25 suffering from mental health issues\n* Living in the relevant health region\n* Attending Relais d'Ile-de-France centers (75, 77, 92, 93) alone or accompanied by someone\n\nExclusion Criteria:\n\n* Young people outside the 11-25 age group - Parents and children who do not speak French or cannot read or write.\n* Refusal to participate\n* Young people in crisis situations requiring immediate hospitalization without care at Le Relais."}, 'identificationModule': {'nctId': 'NCT07186335', 'acronym': 'MGIntegrADO', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Santé des Étudiants de France'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2023-A00883-42'}}, 'armsInterventionsModule': {'interventions': [{'name': 'self-questionnaire', 'type': 'OTHER', 'description': 'Quantitative survey with self-administered questionnaire offered to all patients'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Santé des Étudiants de France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}