{ "FullStudy":{ "Rank":218107, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512641", "OrgStudyIdInfo":{ "OrgStudyId":"11-API-01" }, "Organization":{ "OrgFullName":"Centre Hospitalier Universitaire de Nice", "OrgClass":"OTHER" }, "BriefTitle":"Prevalence of Dissociative Disorders in Children", "OfficialTitle":"Prevalence of Dissociative Disorders in Children in a Population Supported in the Medico-social and Health Structures in Provence Alpes Cote d'Azur" }, "StatusModule":{ "StatusVerifiedDate":"January 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 13, 2011", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 31, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 3, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Centre Hospitalier Universitaire de Nice", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Schizophrenia beginning before 18 years is a clinical entity not well known because of its low incidence and difficulties in the clinical diagnosis.\n\nHowever, in the investigators clinical practice, due to the specialization of the investigators service, the investigators are led to hospital to receive important feel active of patients meeting the Diagnostic and Statistical Manual of Mental Disorders IV text revision (DSM IV-TR) precose schizophrenia.\n\nThe work of us team on the theme of the relationship between Pervasive Developmental Disorders and precose Schizophrenia led us to hypothesize that a number of children in care in the medical and educational institutes, hospitals and day shelters therapeutic part-time symptoms of schizophrenia or a line real early diagnosis of schizophrenia undervalued or not diagnosed.\n\nThe main goal is to estimate the prevalence of dissociative disorders in a population of children in care institutions and medical education in child psychiatry in hospitals and others structures." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Dissociative Disorders", "Schizophrenia" ] }, "KeywordList":{ "Keyword":[ "children dissociative disorders schizophrenia" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Diagnostic", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"301", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Children with Dissociative Disorders", "ArmGroupType":"Experimental", "ArmGroupDescription":"Children will take first the primary stage. If one child is positive, he will pass the secondary stage.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: Primary stage", "Other: Secondary stage" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"Primary stage", "InterventionDescription":"Kiddie-Schedule for Affective Disorders and Schizophrenia", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Children with Dissociative Disorders" ] } },{ "InterventionType":"Other", "InterventionName":"Secondary stage", "InterventionDescription":"children who are positive to the kiddie-SADS (primary stage), will take the tests: PANSS, Scale for the Assessment of Negative Symptoms (SANS), ADI-R, scale TLC and WISC IV", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Children with Dissociative Disorders" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Rate of children diagnosed with dissociative disorders", "PrimaryOutcomeDescription":"Rate of children diagnosed with dissociative disorders: children positive for the test Kiddie-Schedule for Affective Disorders and Schizophrenia (Kiddie-SADS).", "PrimaryOutcomeTimeFrame":"between 2 and 4 hours depending children" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Percentage of children positive for test: Autism Diagnostic Interview-Revise (ADI-R).", "SecondaryOutcomeTimeFrame":"1 day on average" },{ "SecondaryOutcomeMeasure":"Scores of three dimensions of schizophrenia in the Positive And Negative Syndrome Scale (PANSS)", "SecondaryOutcomeDescription":"3 dimensions: positive symptoms, negative symptoms and general psychopathology, based on these scores the diagnostic subtype of schizophrenia is established.", "SecondaryOutcomeTimeFrame":"4 hours" },{ "SecondaryOutcomeMeasure":"Score at the Test Lillois de Communication (TLC)", "SecondaryOutcomeTimeFrame":"30 minutes" },{ "SecondaryOutcomeMeasure":"Score on the Wechsler Intelligence Scale for Children-Fourth Edition (WISC IV)subtests and overall intelligence quotient (IQ).", "SecondaryOutcomeTimeFrame":"4 hours" },{ "SecondaryOutcomeMeasure":"Response time to test verbal fluency, scores on the Trail Making Test A (TMT) and TMT B.", "SecondaryOutcomeTimeFrame":"30 minutes" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\n7 to 18 years\nSupported in the partner institutions of the study\nIQ>35 on the certificate of orientation of the Maison Départementale des Personnes Handicapées (MDPH)\nObtaining the agreement of parents and children\n\nExclusion Criteria:\n\nQI<35 on the certificate file Guidance MDPH\nChildren not speaking french", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"7 Years", "MaximumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Florence ASKENAZY, PU-PH", "OverallOfficialAffiliation":"University hospital of Nice", "OverallOfficialRole":"Study Director" },{ "OverallOfficialName":"Emmanuelle DOR, PH", "OverallOfficialAffiliation":"University hospital of Nice", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"François POINSO, PU-PH", "OverallOfficialAffiliation":"AP-HM", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Michèle BATTISTA, PH", "OverallOfficialAffiliation":"Frejus's hospital", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Michel BOUBLIL, PH", "OverallOfficialAffiliation":"Antibes's hospital", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Psychiatrie infanto-juvénile - Centre Hospitalier d'Antibes", "LocationCity":"Antibes", "LocationZip":"06600", "LocationCountry":"France" },{ "LocationFacility":"Psychiatrie infanto-juvénile-Pôle femme-mère -enfant", "LocationCity":"Fréjus", "LocationZip":"83608", "LocationCountry":"France" },{ "LocationFacility":"Service de psychiatrie de l'enfant et de l'adolescent", "LocationCity":"Marseille", "LocationZip":"13009", "LocationCountry":"France" },{ "LocationFacility":"Service de psychiatrie de l'enfant et de l'adolescent", "LocationCity":"Nice", "LocationZip":"06000", "LocationCountry":"France" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000004194", "ConditionMeshTerm":"Disease" },{ "ConditionMeshId":"D000012559", "ConditionMeshTerm":"Schizophrenia" },{ "ConditionMeshId":"D000004213", "ConditionMeshTerm":"Dissociative Disorders" },{ "ConditionMeshId":"D000003291", "ConditionMeshTerm":"Conversion Disorder" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000019967", "ConditionAncestorTerm":"Schizophrenia Spectrum and Other Psychotic Disorders" },{ "ConditionAncestorId":"D000001523", "ConditionAncestorTerm":"Mental Disorders" },{ "ConditionAncestorId":"D000013001", "ConditionAncestorTerm":"Somatoform Disorders" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M13959", "ConditionBrowseLeafName":"Schizophrenia", "ConditionBrowseLeafAsFound":"Schizophrenia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5977", "ConditionBrowseLeafName":"Dissociative Disorders", "ConditionBrowseLeafAsFound":"Dissociative Disorders", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5098", "ConditionBrowseLeafName":"Conversion Disorder", "ConditionBrowseLeafAsFound":"Dissociative Disorders", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8679", "ConditionBrowseLeafName":"Hysteria", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3396", "ConditionBrowseLeafName":"Mental Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13056", "ConditionBrowseLeafName":"Psychotic Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M20422", "ConditionBrowseLeafName":"Schizophrenia Spectrum and Other Psychotic Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14386", "ConditionBrowseLeafName":"Somatoform Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T1576", "ConditionBrowseLeafName":"Conversion Disorder", "ConditionBrowseLeafAsFound":"Dissociative Disorders", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BXM", "ConditionBrowseBranchName":"Behaviors and Mental Disorders" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }