[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578616":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":41,"responsibleParty":64,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":18,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":18,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":44,"whyStopped":18,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"IRCCS National Neurological Institute \"C. Mondino\" Foundation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental condition cognitive behavioral play intervention CBPI","EXPERIMENTAL","In the CBPI condition, children are given dolls and miniature props to play with, aiming to promote positive thinking. Each session includes stories on health, emotional well-being, social activities, and school life. The researcher teaches problem-solving by modeling steps like identifying the problem, generating solutions, evaluating them, and choosing the best solution. In each session, the researcher models the process four times and makes positive affirmations.\n\nThe CBPI intervention and the free play control condition are similar, with both groups engaging in pretend play. The researcher uses standardized prompts and spends equal time and attention with each child. The key difference is that in the CBPI intervention, the researcher uses dolls to model positive thinking and problem-solving, while encouraging children's imagination and emotional expression. Techniques from play therapy are used to help children integrate their feelings into the stories",[13],"Behavioral: cognitive behavioral play intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"control condition of free playFP","NO_INTERVENTION","The free play (FP) control condition allows the researcher to assess the effects of pretend play and provide positive attention to children. Children in this condition receive the same dolls and props, and hear the same stories as those in the cognitive-behavioral play intervention. After each story, they are encouraged to create their own story, but are free to play as they wish, often engaging in play unrelated to the story prompt. The researcher follows the child's lead, offering positive attention and non-specific praise but does not guide the play. The main difference between the two conditions is that in the FP condition, the researcher provides attention without directing the play, while in the intervention condition, the researcher actively guides the child's play to model problem-solving and positive thinking.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","cognitive behavioral play intervention","In the CBPI condition, children use dolls and miniature props to engage in play aimed at fostering positive thinking, a key element of quality of life. Each session includes stories on health, emotional well-being, social interactions, and school activities. The researcher demonstrates problem-solving steps, such as identifying and evaluating solutions, repeating this process three times. In each session, the researcher models problem-solving four times and provides at least five positive affirmations. Both the CBPI intervention and the free play control condition are similar, with the researcher using standardized prompts and providing equal time and positive attention. The key difference is that in the CBPI condition, the researcher models positive thinking and problem-solving, while in the free play condition, the researcher follows the child's lead without guiding play.",[9],[26],{"name":27,"affiliation":28,"role":29},"martina paola p zanaboni, psy","IRCCS Mondino Foundation","PRINCIPAL_INVESTIGATOR",[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Valentina De Giorgis, MD PhD","CONTACT","0382380289","+39","valentina.degiorgis@mondino.it",{"name":38,"role":33,"phone":39,"phoneExt":35,"email":40},"martina p zanaboni, psy","3495788291","martinapaola.zanaboni@mondino.it",[42],{"facility":43,"status":44,"city":45,"state":18,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Child Neuropsichiatry","RECRUITING","Pavia","27100","Italy","IT",{"type":50,"coordinates":51},"Point",[52,53],9.15917,45.19205,{"lat":53,"lon":52},[56,60],{"name":57,"role":33,"phone":58,"phoneExt":59,"email":36},"Valentina De Giorgis, MD","0382 380289","0039",{"name":61,"role":33,"phone":62,"phoneExt":59,"email":63},"Cinzia Fattore, MD","0382 380385","cinzia.fattore@mondino.it",{"type":65,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[67],{"name":68,"class":69},"Centro Ricerca \"CBPT\" Roma","UNKNOWN","100578616","effect-of-cognitive-behavioral-play-intervention-and-epilepsy-100578616",false,"NCT06813612","Effect of Cognitive Behavioral Play Intervention and Epilepsy","The Effects of Cognitive Behavioral Play Intervention on the Quality of Life of Children With Childhood-onset Epileptic Syndromes.\"","For the purposes of the study, children aged between 6 and 10 years, of both sexes, will be recruited.\n\n\\- inclusion criteria Children diagnosed with the following types of epilepsy will be included: childhood self-limiting focal epilepsy (SeLFE); childhood absence epilepsy (CAE); self-limiting centrotemporal paroxysmal epilepsy (SeLECTS); self-limiting epilepsy with autonomic seizures (SeLEAS); childhood occipital epilepsy (COVE); photosensitive occipital lobe epilepsy (POLE).\n\nExclusion criteria:\n\n* Children with epilepsy in comorbidity with cognitive disabilities (the relevant cognitive disabilities must be specified with IQ scores)\n* reduced visual or expressive hearing acuity (visually impaired or deaf) will be excluded.","ALL","6 Years","10 Years",{"count":81,"type":82},52,"ESTIMATED","INTERVENTIONAL",[85],"NA","The goal of this clinical trial is to assess the effectiveness of Cognitive Behavioral Play Therapy interventions in patients with epilepsy.\n\nChildren with epilepsy will be randomly assigned to one of two intervention conditions: the experimental group will receive cognitive-behavioral play intervention, while the control group will engage in free play. Assessments will be done at the start (T0) and end (T1) of the intervention, measuring behaviors, coping strategies, positive thinking, problem-solving, and quality of life.",[88,89],"Epilepsy","Epilepsy in Children",[91,92,93],"epilepsy","psychology","cognitive behavioral play therapy","2025-02-03",{"date":96,"type":97},"2025-02-07","ACTUAL",{"date":99,"type":97},"2024-10-07",{"date":101,"type":82},"2026-10",{"name":5,"class":6},1]