[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654877":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":24,"studyPopulation":25,"armGroups":21,"interventions":21,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":50,"collaborators":52,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":21,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":21,"studyType":68,"phases":21,"briefSummary":69,"conditions":70,"keywords":21,"overallStatus":35,"whyStopped":21,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"IRCCS Fondazione Stella Maris","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"EDI-YC (Emotional Dysregulation Inventory-Young Child)","EDI-YC is a questionnaire developed to assess emotional dysregulation (ED) in children aged 2 to 5 years, both with and without neuropsychological disabilities. Parents are asked to rate their children's emotional behaviors by assigning a score reflecting the frequency and intensity of emotional dysregulation manifestations (0 = not at all; 4 = very serious).","Baseline",[14,17],{"measure":15,"description":16,"timeFrame":12},"BRIEF-P (Behavior Rating Inventory of Executive Function-Preschool Version)","BRIEF-P is a parent questionnaire that assesses various aspects of Executive Functions in preschool-aged children, including Inhibition, Emotional Control, Shifting\u002FFlexibility, Planning and Organization, and Working Memory. Parents evaluate, using a 3-point rating scale (1 = never; 3 = always), the frequency with which the behaviors described in each item occur.",{"measure":18,"description":19,"timeFrame":20},"Sleep-wake EEG recording","Sleep-wake EEG is an electroencephalographic recording that evaluates brain electrical activity during wakefulness and sleep.","Up to 24 weeks",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":6,"maskingInfo":21},"CASE_ONLY","This observational study aims to collect data (both prospective and retrospective from 2025) regarding a sample of children aged between 3 and 6 years who were referred in a naturalistic setting to the Department of Developmental Psychiatry and Psychopharmacology at the IRCCS Stella Maris Foundation and to the Child Neuropsychiatry Unit of the IRCCS Giannina Gaslini (multicenter study) for diagnostic assessment, and who received a diagnosis of an internalizing and\u002For externalizing disorder following the clinical assessment. Through a back-translation procedure, our research group translated and adapted into Italian the \"Emotion Dysregulation Inventory Young Child (EDI-YC)\" questionnaire for the assessment of emotional-behavioral dysregulation in preschool children. Children will be enrolled according to the eligibility criteria and after informed consent for participation in the study has been signed by both parents\u002Flegal guardians. For the collection of retrospective data only, as provided for by the study, and where explicit consent from the parents\u002Flegal guardians could not be obtained, the data will be collected in accordance with Article 110-bis, paragraph 4, of the Italian Privacy Code. The data about emotional-behavioral dysregulation obtained from the completion of the EDI-YC will be correlated with data obtained from other questionnaires and from the clinical assessment in order to achieve a characterization of clinical phenotypes based on the psychopathological dimensions investigated.\n\nExecutive functions will be investigated in the sample of preschool children through a correlation analysis between BRIEF-P scores and EEG recordings","For the study, patients aged between 3 and 6 years who were referred in a naturalistic setting for diagnostic assessment, and who received a diagnosis of an emotional-behavioral disorder following the routine clinical assessment, will be enrolled.",[27],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"valentina viglione","CONTACT","39050886293","valentina.viglione@fsm.unipi.it",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":37,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"IRCCS Stella Maris","RECRUITING","Pisa","Italy","56128","IT",{"type":41,"coordinates":42},"Point",[43,44],10.4036,43.70853,{"lat":44,"lon":43},[47],{"name":48,"role":29,"phone":49,"phoneExt":21,"email":31},"valentina viglione, MD","050886293",{"type":51,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[53],{"name":54,"class":6},"Gaslini Children's Hospital","100654877","emotional-dysregulation-and-other-psychopathological-dimensions-in-clinical-preschoolers-100654877",false,"NCT07805668","Emotional Dysregulation and Other Psychopathological Dimensions in Clinical Preschoolers","Clinical Characterization of Preschool Children With Internalizing and Externalizing Symptoms: The Role of Empathy, Restricted and Repetitive Behaviors, Emotional-Behavioral Dysregulation, and Executive Functions","Inclusion Criteria:\n\nInclusion criteria:\n\n* Age between 3 and 6 years\n* Presence of an internalizing and\u002For externalizing disorder\n* Parent completion of the questionnaires\n* Parent\u002Fcaregiver signed informed consent for participation in the study\n\nExclusion criteria:\n\n* Age greater than 6 years","ALL","3 Years","6 Years",{"count":66,"type":67},40,"ESTIMATED","OBSERVATIONAL","The purpose of the study is to investigate the emotional-behavioral dysregulation and its possible correlation with the main demographic and psychopathological variables in a sample of preschool children with internalizing and externalizing disorders.",[71],"Behavioral and Emotional Disorder With Onset in Childhood","2026-09-01",{"date":74,"type":75},"2026-09-04","ACTUAL",{"date":77,"type":75},"2025-10-14",{"date":79,"type":67},"2026-11-30",{"name":5,"class":6},1]