[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566546":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":79,"collaborators":81,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":24,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":24,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Istituto per la Ricerca e l'Innovazione Biomedica","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Food selectivity Group (2)","EXPERIMENTAL","15 children in the comparator group who will undergo the treatment perform the procedure individually using the traditional method.",[13],"Other: Traditional food selectivity protocol",{"label":15,"type":10,"description":16,"interventionNames":17},"Food selectivity group (1)","15 children in the experimental group who will undergo the treatment perform the procedure individually with exposure to foods through Oculus",[18],"Other: Individual food selectivity protocol",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Individual food selectivity protocol","Children in the experimental group wear Oculus headsets and interact with virtual foods for 20 minutes. In the \"Pairing in the Kitchen\" phase, Oculus is removed. Two identical plates with 6 foods are placed in front of the child. The operator, seated next to the child, interacts with the food without eating it, maintaining a positive expression, and discussing non-food topics. No prompts to eat are given, and the child can leave at any time. Progress to the next phase if the child sits calmly for 30 seconds across 3 sessions.\n\nShaping Phase: Two identical plates are prepared. The operator comments on the food and keeps a small container of the child's favorite food visible but out of reach. Any food-related behavior is reinforced with praise and the favorite food. Target behaviors are adjusted if no response occurs for 15 seconds or if negative emotions are observed. Differential reinforcement is used.",[15],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Traditional food selectivity protocol","Step 1:Pairing in the Kitchen Propose enjoyable activities in the kitchen. Move to Step 2 when the child plays in the kitchen for 5 minutes over 3 consecutive sessions.\n\nStep 2:Transition to Kitchen Two plates with 6 identical foods are placed in the kitchen. The operator engages the child in a welcome game, waiting 30 seconds for spontaneous interaction. If no response, the operator prompts the child to go to the kitchen. If the child doesn't follow within 30 seconds, the session is postponed. The operator sits next to the child and interacts with the food, without encouraging the child to eat. Progress when the child stays seated for 30 seconds without problem behavior for 3 sessions.\n\nStep 3:Shaping Two plates are prepared, and the operator comments on the food. A visible container with the child's favorite food is used for reinforcement. Target behaviors are reinforced with praise and the favorite food. Adjust behaviors if there's no response for 15 seconds or negative emotions occur",[9],[30],{"name":31,"affiliation":5,"role":32},"Flavia Marino","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":24,"email":37},"CONTACT","+393395798263","flavia.marino@irib.cnr.it",{"name":39,"role":35,"phone":24,"phoneExt":40,"email":41},"Giovanni Pioggia","+393203390892","giovanni.pioggia@irib.cnr.it",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":46,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Messina","Italy","98164","IT",{"type":50,"coordinates":51},"Point",[52,53],15.55256,38.19394,{"lat":53,"lon":52},[56,57,59,60,61,63,65,67,69,71,73,75,77],{"name":31,"role":35,"phone":36,"phoneExt":24,"email":37},{"name":58,"role":35,"phone":24,"phoneExt":24,"email":24},"M.Valeria Maiorana",{"name":39,"role":35,"phone":24,"phoneExt":24,"email":24},{"name":31,"role":35,"phone":24,"phoneExt":24,"email":24},{"name":62,"role":35,"phone":24,"phoneExt":24,"email":24},"Germana Doria",{"name":64,"role":35,"phone":24,"phoneExt":24,"email":24},"Chiara Failla",{"name":66,"role":35,"phone":24,"phoneExt":24,"email":24},"Noemi Vetrano",{"name":68,"role":35,"phone":24,"phoneExt":24,"email":24},"Ileana Scarcella",{"name":70,"role":35,"phone":24,"phoneExt":24,"email":24},"Roberta Minutoli",{"name":72,"role":35,"phone":24,"phoneExt":24,"email":24},"Paola Chilà",{"name":74,"role":35,"phone":24,"phoneExt":24,"email":24},"Anna Meduri",{"name":76,"role":35,"phone":24,"phoneExt":24,"email":24},"Chiara Marraffa",{"name":78,"role":35,"phone":24,"phoneExt":24,"email":24},"Gaia Roccaforte",{"type":32,"investigatorFullName":31,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Principal Investigator",[82],{"name":83,"class":84},"Fondazione di Comunità Messina onlus","UNKNOWN","100566546","exploring-virtual-reality-as-an-intervention-for-food-selectivity-a-clinical-trial-100566546",false,"NCT06656585","Exploring Virtual Reality As an Intervention for Food Selectivity: a Clinical Trial","Evaluation of the Effect of a Food Selectivity Intervention Through Virtual Reality in Children with Autism Spectrum Disorders","Inclusion Criteria:\n\n* Food selectivity upon parental referral\n* Child with diagnosis of autism\n\nExclusion Criteria:\n\n* presence of other medical disorders","ALL","4 Years","10 Years",{"count":96,"type":97},30,"ESTIMATED","INTERVENTIONAL",[100],"NA","Food selectivity is a common challenge among children with Autism Spectrum Disorder (ASD), with significant impacts on their nutrition and well-being. The main purpose of this study is to promote children's active participation in mealtime routines and encourage experimentation with new foods through an approach that emphasizes joy and serenity during mealtimes. The study will involve children with ASD between the ages of 4 and 10 years, of both sexes. Food selectivity will be assessed through interviews with parents and the use of specially created cards.\n\nThe protocol will include 45-minute sessions, twice a week, for a total of 48 sessions. The children will wear an Oculus headset and be exposed to the foods through this virtual reality tool, enhancing their engagement and willingness to try new foods in a fun and immersive way.",[103,104],"Autism","Autism Spectrum Disorder",[106,107,108,109],"autism","children","food selectivity","virtual reality","2024-10-23",{"date":112,"type":113},"2024-10-24","ACTUAL",{"date":115,"type":113},"2024-09-01",{"date":117,"type":97},"2025-07-17",{"name":5,"class":6},1]