protocolSection identificationModule nctId: NCT06335030, orgStudyIdInfo id: 2.1_AUT-SP2_001_Tancredi, briefTitle: Sensory and Behavioral Aspects With Particular Attention to Food Selectivity in Children With Autism, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-03-29, primaryCompletionDateStruct date: 2024-01-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: IRCCS Fondazione Stella Maris, class: OTHER, collaborators name: Ospedale Borgo Trento - Verona, collaborators name: Università degli Studi di Trento, descriptionModule briefSummary: Brief Summary: Eating problems and in particular food selectivity is a condition that worsens a long-life disorder such as Autism Spectrum Disorder (ASD), both on an individual level, both on family and social ones .Children (2-6 years) diagnosed with ASD according to Diagnostic and Statistical Manual of Mental Disorders 5 Edition (DSM5) criteria were enrolled in an observational, cross-sectional and multicentric study conducted by three different Italian clinical centers. Regarding this sample, principal aims of the study are to describe characteristics of food selectivity, to evaluate its correlation with ASD symptoms, with cognitive and adaptive functioning of ASD preschoolers, to describe its impact on parental stress., conditionsModule conditions: Autism Spectrum Disorder, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Child Oral and Motor Proficiency Scale (ChOMPS), primaryOutcomes measure: Brief Autism Mealtime Behavior Inventory (BAMBI), primaryOutcomes measure: Sensory Profile 2 (SP2), primaryOutcomes measure: Child Behavior Checklist (CBCL), primaryOutcomes measure: Parenting Stress Index (PSI), primaryOutcomes measure: Observation of child meal-time, primaryOutcomes measure: Food Diary, primaryOutcomes measure: Gastrointestinal severity symptom index (GSSI), primaryOutcomes measure: Mac Arthur, secondaryOutcomes measure: Autism Quotient (AQ), secondaryOutcomes measure: Autism Diagnostic Observation Schedule-2 (ADOS-2), secondaryOutcomes measure: Vineland-II scales (VABS II), eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: IRCCS Stella Maris, status: RECRUITING, city: Pisa, state: PI, zip: 56128, country: Italy, contacts name: Raffaella Tancredi, role: CONTACT, phone: +39050886292, email: raffaella.tancredi@fsm.unipi.it, contacts name: Roberta Nencioli, role: CONTACT, phone: +39050886347, email: roberta.nencioli@fsm.unipi.it, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Università degli Studi di Trento-Laboratorio di Osservazione, Diagnosi e Formazione, status: TERMINATED, city: Rovereto, zip: 38068, country: Italy, geoPoint lat: 45.8904, lon: 11.04053, locations facility: Azienda Ospedaliera Borgo Trento, status: TERMINATED, city: Verona, zip: 37126, country: Italy, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False