Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 8:24 AM
Study NCT ID:
NCT04280367
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2020-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Learning and Executive Function Disorders in Children and Psychosis Risk at Adult-age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-21', 'studyFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2020-02-20', 'lastUpdatePostDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Semi-structured interview', 'timeFrame': 'At baseline', 'description': 'Assessement with Comprehensive Assessment of At-Risk Mental States (CAARMS) during 6 to 90 minutes at the center of Raymond Poincaré hospital.\n\nThe unique collection during the interview, quotation of each patient will be given from the assessement.\n\nThere will be 4 groups by the results: CAARMS negative subjects, vulnerable subjects, attenuated psychosis subjects and subjects with brief and limited intermittent psychotic syndrome. The further statistic comparison will be done between the 3 last groups classified with results of CAARMS.'}], 'secondaryOutcomes': [{'measure': 'Autistic screening', 'timeFrame': 'At baseline', 'description': 'Autism-spectrum quotient (AQ) auto-questionnaire will be used to evaluate difficulty in social interaction.'}, {'measure': 'Anxiety measuring', 'timeFrame': 'At baseline', 'description': 'An inventory for measuring clinical anxiety: Beck Anxiety Inventory'}, {'measure': 'Social interaction difficulty evaluation', 'timeFrame': 'At baseline', 'description': 'Liebowitz Social Anxiety Scale as questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['learning disorders', 'executive function disorders', 'psychosis', 'children', 'adult-age'], 'conditions': ['Schizophrenia', 'Learning Disorders', 'Executive Function Disorders']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study aims to study transition toward schizophrenia in patients with learning disorders, and to compare the risk between patients with specific learning disorders, and patients with complexed learning disorders (by two types: patients with other neuro-developmental disorders including executive function disorders, and patients with anxiety).', 'detailedDescription': 'As secondary objectives, the study aims to:\n\n* argue the clinical predicted markers (neuropsychological) transition toward psychosis.\n* test the feasibility and the acceptability of a early diagnosis for a potential applicable guidance for different referent centers of learning in French territory.\n* have a better classification of patients with learning disorders in order to target a prospective primary prevention of risk of psychosis via the questionnaires (AQ of Baron-Cohen: Autism-spectrum quotient auto-questionnaire; Inventory of Beck Anxiety Inventory, auto-questionnaire for panic disorder and general anxiety; Liebowitz Social Anxiety Scale).\n* improve identification of the early signs and the early emerging psychological diseases intervention management (schizophrenia).\n* Psychic disability: prevent and reduce non-seeking care and accompaniment situations, and risk of rupture of care.\n* permitting better care of psychosocial rehabilitation with cognitive evaluation.\n\nThis study will be conducted in Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré, APHP, in France.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients between 15 and 30 years, suffering learning disorders complicated with two orders: with other neuro-developmental, or with anxiety (vs specific: comparator group).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients born between 1990 and 2005, have been cared by Dr Schlumberger in 2014 in the center of language and learning disorders at Raymond Poincaré hospital;\n* With severe learning disorders: deficiency in school work, need at least one medical appointment and long-term rehabilitation in the center of language and learning disorders at Raymond Poincaré hospital;\n* Affiliated to a social protection schema;\n* Written informed consent signed.\n\nExclusion Criteria:\n\n* Absence of learning disorder;\n* Intellectual deficiency;\n* Epilepsia;\n* Patients who will performed follow-up at Chartres city;\n* Patients under guardianship or curatorship;\n* Foreign patients under AME schema, a medical help from the state in France.'}, 'identificationModule': {'nctId': 'NCT04280367', 'acronym': 'DYS FUTURS UHR', 'briefTitle': 'Learning and Executive Function Disorders in Children and Psychosis Risk at Adult-age', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Childhood Learning and Executive Function Disorders and Risk of Psychosis in the Adulthood', 'orgStudyIdInfo': {'id': 'APHP191093'}, 'secondaryIdInfos': [{'id': '2019-A02663-54', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Comparator group', 'description': 'Specific learning disorders group', 'interventionNames': ['Diagnostic Test: Standardised semi-structured talk', 'Diagnostic Test: Autistic spectre disorder screening', 'Diagnostic Test: Anxiety measuring']}, {'label': 'neuro-developmental complexed group', 'description': 'Group of neuro-developmental complexe of learning', 'interventionNames': ['Diagnostic Test: Standardised semi-structured talk', 'Diagnostic Test: Autistic spectre disorder screening', 'Diagnostic Test: Anxiety measuring']}, {'label': 'Complexed with anxiety', 'description': 'Disorders in learning with anxiety', 'interventionNames': ['Diagnostic Test: Standardised semi-structured talk', 'Diagnostic Test: Autistic spectre disorder screening', 'Diagnostic Test: Anxiety measuring']}], 'interventions': [{'name': 'Standardised semi-structured talk', 'type': 'DIAGNOSTIC_TEST', 'description': 'Comprehensive assessment of at-risk mental states (CAARMS) will be used.', 'armGroupLabels': ['Comparator group', 'Complexed with anxiety', 'neuro-developmental complexed group']}, {'name': 'Autistic spectre disorder screening', 'type': 'DIAGNOSTIC_TEST', 'description': 'Autism-spectrum quotient (AQ) auto-questionnaire will be used.', 'armGroupLabels': ['Comparator group', 'Complexed with anxiety', 'neuro-developmental complexed group']}, {'name': 'Anxiety measuring', 'type': 'DIAGNOSTIC_TEST', 'description': 'An inventory for measuring clinical anxiety: Beck Anxiety Inventory (BAI); Liebowitz Social Anxiety Scale.', 'armGroupLabels': ['Comparator group', 'Complexed with anxiety', 'neuro-developmental complexed group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'overallOfficials': [{'name': 'Emilie SCHLUMBERGER, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré, APHP'}, {'name': 'Albane Mansoux', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre de référence des troubles du langage et des apprentissages, Hôpital Raymond Poincaré, APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}