Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:00 PM
Study NCT ID:
NCT07429968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synergy in Mental Health Care: Strengthening Collaborations in a Shared Care System for Child and Adolescent Psychiatry (DSPPea34).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Highlighting by the DELPHI method of the main facilitators of involvement in the DSPPea34 pathway, from successive rounds of proposal prioritization', 'timeFrame': '3 months', 'description': 'These facilitators will be identified at different stages: 1) addressing, 2) evaluation, 3) orientation, 4) collaboration between partners, 5) exit from the device and will allow to evolve the specifications of DSPPea in view of its generalization.\n\nEach round includes closed-ended items rated on a 9-point Likert scale (1 = strongly disagree; 9 = strongly agree) assessing both the content and the wording of each proposal. Free-text fields allow participants to provide comments and suggested rewording. Iterative Adaptation Across Rounds: Based on prior-round results, items may be revised, added, or removed. Refinements aim to improve clarity and relevance, while preserving traceability of changes. Consensus Rule (Stopping/Exclusion Criterion for Items): If an item achieves ≥70% agreement (to retain or to remove the proposal) with concordant votes in both Round 1 and Round 2, the proposal is considered'}], 'secondaryOutcomes': [{'measure': 'Clinical Characterization at Baseline', 'timeFrame': 'At program entry (Baseline)', 'description': "Clinical profile including reason for referral, prior or ongoing mental-health follow-up, and functioning assessment coded as ICD-11 diagnostic categories and Children's Global Assessment"}, {'measure': 'Reason for referral to the program', 'timeFrame': 'Baseline', 'description': 'Proportion of patients according to broad categories of referral reasons Unit of Measure: % of participants.'}, {'measure': 'Number of Requests and Referrals (DSPPea34 vs. Outside DSPPea34)', 'timeFrame': 'Baseline', 'description': 'Count of requests and final referral directions (within DSPPea34 or redirected outside DSPPea34).'}, {'measure': 'Number of Psychiatric Clinical Interviews within DSPPea34', 'timeFrame': 'At program entry (intake) to program completion (from 1 month to 12 months)', 'description': 'Total number of psychiatric clinical interviews conducted as part of DSPPea34.'}, {'measure': 'Number of Joint City-Hospital Follow-Ups', 'timeFrame': 'At program entry (intake) to program completion (from 1 month to 12 months)', 'description': 'Count of joint follow-up episodes involving community (city) providers and hospital-based teams.'}, {'measure': 'Number of Follow-Ups Coordinated by Primary Care', 'timeFrame': 'At program entry (intake) to program completion (from 1 month to 12 months)', 'description': 'Count of follow-up episodes coordinated by primary care actors (e.g., GP or pediatrician).'}, {'measure': 'Youth Status at Program Exit', 'timeFrame': 'At program entry (intake) to program completion (from 1 month to 12 months)', 'description': 'Disposition at discharge (e.g., type of ongoing follow-up, referral destination) and youth outcome at exit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children/adolescents', 'Mental disorders', 'City-hospital care pathway'], 'conditions': ['DSPPea34', 'Young People Aged 6-18', 'Acute and Mild Psychological Disorders']}, 'descriptionModule': {'briefSummary': 'DSPPea34 (Shared Care Program for Children and Adolescents) is an experimental health program designed to provide rapid, guided care orientation for youth aged 6-18 when a first-line psychological follow-up is considered by a general practitioner or pediatrician. The program links hospital-based services and community providers by offering prompt contact and assessment by a registered nurse and/or psychiatrist, with structured feedback to the referring physician.\n\nPrimary objective: To identify facilitators that support the engagement of all professionals involved in the care pathway of children and adolescents with psychological difficulties. Facilitators will be mapped across five stages of the pathway: (1) intake, (2) assessment, (3) orientation/referral, (4) inter-partner collaboration, and (5) discharge from the program. Results will be used to refine DSPPea34 specifications to inform broader implementation.\n\nMethods and study population (primary objective): A Delphi survey will be conducted with stakeholders directly interacting with families and youth within DSPPea34 (e.g., general practitioners (GP), pediatricians, program clinicians) as well as with program users.\n\nSecondary objectives and data sources: To describe (i) the sociodemographic and clinical characteristics of youth using DSPPea34 services and (ii) their care trajectories using quantitative methods. Data will be extracted from DSPPea34 records via the SPICO coordination file (the tool used to facilitate exchanges between the GP/pediatrician, DSPPea34, and the psychologist in charge of follow-up) and complemented by soliciting longitudinal outcome information from the referring physician based on DSPPea34 follow-up.\n\nFindings from this mixed-methods evaluation are expected to guide the optimization and potential scale-up of the DSPPea34 model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the population of this study (participants responding to the DELPHI questionnaire) includes professionals directly in contact with families and young people within the framework of DSPPea34 as well as users of DSPPea34.\n\n* the pediatricians or general practitioners who have referred a child or adolescent to the DSPPea34\n* the hospital and private psychiatrist doctors who conducted an initial assessment as part of the DSPPea34\n* the city psychologists who are partners of the program having followed at least one child or adolescent within the framework of the DSPPea34\n* the Coordination Nurse (IDC) of DSPPea34\n* users (legal guardians and young beneficiaries of the care pathway of DSPPea34)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the professionals directly in contact with families or young people within the framework of DSPPea34 as well as users of DSPPea34'}, 'identificationModule': {'nctId': 'NCT07429968', 'acronym': 'SYNERGIE', 'briefTitle': 'Synergy in Mental Health Care: Strengthening Collaborations in a Shared Care System for Child and Adolescent Psychiatry (DSPPea34).', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Synergy in Mental Health Care: Strengthening Collaborations in a Shared Care System for Child and Adolescent Psychiatry (DSPPea34).', 'orgStudyIdInfo': {'id': 'RECHMPL24_0352'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the professionals directly in contact with families and young people within the framework of DSPPea3', 'interventionNames': ['Other: structured online questionnaire']}, {'label': 'users of the DSPPea34', 'interventionNames': ['Other: structured online questionnaire', 'Other: descriptive analysis of patient characteristics and their care pathways, based on electronic medical records']}], 'interventions': [{'name': 'structured online questionnaire', 'type': 'OTHER', 'description': 'A structured, online Delphi survey conducted in up to three iterative rounds to co-develop and refine proposals related to the DSPPea34 specifications. Questionnaires are developed by study facilitators based on the initial DSPPea34 specifications and new proposals arising from the interim evaluation.\n\nContent and Response Format:\n\nEach round includes closed-ended items rated on a 9-point Likert scale (1 = strongly disagree; 9 = strongly agree) assessing both the content and the wording of each proposal.\n\nFree-text fields allow participants to provide comments and suggested rewording.\n\nIterative Adaptation Across Rounds:\n\nBased on prior-round results, items may be revised, added, or removed. Refinements aim to improve clarity and relevance, while preserving traceability of changes.\n\nConsensus Rule (Stopping/Exclusion Criterion for Items):\n\nIf an item achieves ≥70% agreement (to retain or to remove the proposal) with concordant votes in both Round 1 and Round 2, the proposal is considered', 'armGroupLabels': ['the professionals directly in contact with families and young people within the framework of DSPPea3', 'users of the DSPPea34']}, {'name': 'descriptive analysis of patient characteristics and their care pathways, based on electronic medical records', 'type': 'OTHER', 'description': 'Data collected from all users of the DSPPea34 program since its inception (approximately 1,200 cases) will include:\n\n* sociodemographic data (age, gender, living environment (urban, semi-urban, rural)\n* diagnosis at the end of the initial psychiatric assessment of the DSPPea34 program\n* referring physician\n* schooling (grade, mainstream or specialized environment)\n* existence of previous psychiatric or psychological follow-up\n* referrals by DSPPea34 staff and reasons (without collection of individual data for young people not included in DSPPea34 at the end of the staff meeting)\n* referrals at the end of the medical consultation and reasons\n* end-of-process referrals.', 'armGroupLabels': ['users of the DSPPea34']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montpellier', 'state': 'Hérault', 'country': 'France', 'contacts': [{'name': 'Diane PURPER OUAKIL, MD PhD', 'role': 'CONTACT'}], 'facility': "CHU Montpellier - Réseau DSPPea34 de l'Hérault", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Diane PURPER OUAKIL, MD PhD', 'role': 'CONTACT', 'email': 'mpea@chu-montpellier.fr', 'phone': '04 67 33 60 09', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Diane PURPER OUAKIL, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHU de Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': "UMR UA11INSERM-UMIDESP Institut Desbrest d'Épidémiologie et de Santé Publique", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}