[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567329":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":43,"responsibleParty":166,"collaborators":168,"id":172,"slug":173,"hasResults":174,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":27,"eligibilityCriteria":178,"healthyVolunteers":174,"sex":179,"minAge":180,"maxAge":181,"enrollmentInfo":182,"targetDuration":32,"studyType":185,"phases":186,"briefSummary":188,"conditions":189,"keywords":195,"overallStatus":46,"whyStopped":32,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},{"fullName":5,"class":6},"IRCCS Eugenio Medea","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental arm involving parents","EXPERIMENTAL","Subjects assigned to this arm will receive the intervention focused on intersubjective prelinguistic and socio-communicative skills. A parent is required to participate in all sessions.",[13],"Behavioral: Intervention focused on intersubjective prelinguistic and socio-communicative skills",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard speech therapy","ACTIVE_COMPARATOR","Participants in this group will receive standard speech therapy. Parental involvement will only occur if strictly necessary.",[19],"Behavioral: Standard speech therapy intervention",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Intervention focused on intersubjective prelinguistic and socio-communicative skills","The intervention consists of 8 45-minute, weekly sessions over two months. These sessions may take place in various settings, such as free play, snack time, or structured activities. The speech therapist will use these settings to help parents observe intersubjective and social-communicative behaviors, providing guidance and strategies to support them.\n\nThe following topics will be addressed: Early dyadic interaction; First signals of comprehension; Communicative intentionality; Gestures; Attention; Verbal and motor routine; Lexical and syntactic comprehension; Socio-conversational skills.\n\nThese topics are not structured into rigid levels for each session. Instead, several topics may be addressed within the same session and revisited across multiple sessions. This flexibility allows the speech therapist to adapt the intervention based on observations, interactions with the child, and discussions with the parent. Parents in the IG arm will receive a bespoke designed booklet containing",[9],[27],"SPEAK",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Standard speech therapy intervention","The standard speech therapy intervention, as typically conducted in rehabilitation centers, consists of 8 weekly sessions, each lasting 45 minutes, over a two-month period (same as the experimental intervention). During these sessions, the therapist may provide various stimulations aimed at enhancing the child's vocalization, verbal comprehension, and speech production. While the therapist may offer guidance to parents on how to continue these stimulations in daily routines, they will not be directly involved in the sessions unless strictly necessary.",[15],null,[34,39],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Sandra Strazzer, M.D.","CONTACT","+39031877854","sandra.strazzer@lanostrafamiglia.it",{"name":40,"role":36,"phone":41,"phoneExt":32,"email":42},"Niccolò Butti, Ph.D.","+39031877464","niccolo.butti@lanostrafamiglia.it",[44,62,75,89,104,116,130,143,156],{"facility":45,"status":46,"city":47,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Associazione \"La Nostra Famiglia\" - Centro di Riabilitazione Ambulatoriale","RECRUITING","Como","22100","Italy","IT",{"type":52,"coordinates":53},"Point",[54,55],9.0832,45.80819,{"lat":55,"lon":54},[58],{"name":59,"role":36,"phone":60,"phoneExt":32,"email":61},"Site responsible","+39031525755","amb.como@lanostrafamiglia.it",{"facility":63,"status":46,"city":64,"state":47,"zip":65,"country":49,"countryCode":50,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Associazione \"La Nostra Famiglia\" - Centro di Riabilitazione Ambulatoriale e Diurno (CDC)","Ponte Lambro","22037",{"type":52,"coordinates":67},[68,69],9.22455,45.82539,{"lat":69,"lon":68},[72],{"name":59,"role":36,"phone":73,"phoneExt":32,"email":74},"+39031625252","pontelambro.cdr@lanostrafamiglia.it",{"facility":76,"status":46,"city":77,"state":78,"zip":79,"country":49,"countryCode":50,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Associazione \"La Nostra Famiglia\" - Centro di Riabilitazione Ambulatoriale, Diurno (CDC) e Residenziale","Bosisio Parini","Lecco","23842",{"type":52,"coordinates":81},[82,83],9.29,45.80075,{"lat":83,"lon":82},[86],{"name":35,"role":36,"phone":87,"phoneExt":32,"email":88},"+39031877111","urp.bosisio@lanostrafamiglia.it",{"facility":90,"status":46,"city":77,"state":78,"zip":79,"country":49,"countryCode":50,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Associazione La Nostra Famiglia - IRCCS E. Medea",{"type":52,"coordinates":92},[82,83],{"lat":83,"lon":82},[95,98,100,102],{"name":96,"role":36,"phone":87,"phoneExt":32,"email":97},"Scientific Secretary","medea@lanostrafamiglia.it",{"name":35,"role":99,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"name":40,"role":101,"phone":32,"phoneExt":32,"email":32},"SUB_INVESTIGATOR",{"name":103,"role":101,"phone":32,"phoneExt":32,"email":32},"Chiara Porro, Psy.D.",{"facility":105,"status":46,"city":78,"state":78,"zip":106,"country":49,"countryCode":50,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Associazione \"La Nostra Famiglia\" - Centro di Riabilitazione Ambulatoriale, Diurno (CDC) e Domiciliare","23900",{"type":52,"coordinates":108},[109,110],9.39704,45.85589,{"lat":110,"lon":109},[113],{"name":59,"role":36,"phone":114,"phoneExt":32,"email":115},"+390341495564","lecco@lanostrafamiglia.it",{"facility":117,"status":46,"city":118,"state":119,"zip":120,"country":49,"countryCode":50,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Associazione \"La Nostra Famiglia\"- Centro di Riabilitazione Ambulatoriale","Sesto San Giovanni","Milano","20099",{"type":52,"coordinates":122},[123,124],9.22585,45.53329,{"lat":124,"lon":123},[127],{"name":59,"role":36,"phone":128,"phoneExt":32,"email":129},"+39022428594","sestosg@lanostrafamiglia.it",{"facility":117,"status":46,"city":131,"state":132,"zip":133,"country":49,"countryCode":50,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Carate Brianza","Monza E Brianza","20841",{"type":52,"coordinates":135},[136,137],9.23723,45.67574,{"lat":137,"lon":136},[140],{"name":59,"role":36,"phone":141,"phoneExt":32,"email":142},"+390362904035","carate.brianza@lanostrafamiglia.it",{"facility":117,"status":46,"city":144,"state":145,"zip":146,"country":49,"countryCode":50,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Cislago","Varese","21040",{"type":52,"coordinates":148},[149,150],8.97272,45.65928,{"lat":150,"lon":149},[153],{"name":59,"role":36,"phone":154,"phoneExt":32,"email":155},"+390332866080","vedano.olona@lanostrafamiglia.it",{"facility":157,"status":46,"city":158,"state":145,"zip":146,"country":49,"countryCode":50,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Associazione \"La Nostra Famiglia\"- Centro di Riabilitazione Ambulatoriale, Diurno (CDC)","Vedano Olona",{"type":52,"coordinates":160},[161,162],8.88771,45.7757,{"lat":162,"lon":161},[165],{"name":59,"role":36,"phone":32,"phoneExt":32,"email":32},{"type":167,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[169],{"name":170,"class":171},"Associazione La Nostra Famiglia, Como, Italy","UNKNOWN","100567329","speech-therapy-and-parenting-for-early-socio-communicative-skills-100567329",false,"NCT06666777","Speech Therapy and Parenting for Early Socio-communicAtive sKills","Speech Therapy and Parenting for Early Socio-communicative Skills in Children With Neurodevelopmental Disabilities","Inclusion criteria:\n\nFor children:\n\n* Age between 6 months (corrected age in cases of prematurity) and 5 years.\n* Documented developmental delay and\u002For socio-communicative difficulties, based on clinical signs or standardized developmental scales (e.g., Griffiths Scales).\n* Mental age of at least 6 months.\n* Diagnosis of neurodevelopmental disability, including cerebral palsy, genetic syndromes, rare diseases with non-progressive neurological impairments, or congenital disorders of undetermined nature.\n\nFor parents:\n\n* Adult age (≥ 18 yo)\n* Good knowledge and fluency in Italian.\n* No manifest psychiatric conditions.\n* No documented intellectual disability.\n\nExclusion criteria:\n\nFor children:\n\n* Age greater than 5 years at the time of recruitment.\n* Mental age below 6 months.\n* Absence of developmental delay (developmental quotient \\> 85) and socio-communicative difficulties.\n* Diagnosis of neurodevelopmental disability resulting from neurodegenerative diseases or brain tumor outcomes.\n* Severe sensory impairments (profound deafness and\u002For blindness).\n\nFor Parents:\n\n* Inability to speak Italian.\n* Documented psychiatric conditions or intellectual disability.","ALL","6 Months","59 Months",{"count":183,"type":184},60,"ESTIMATED","INTERVENTIONAL",[187],"NA","Every year, millions of children are diagnosed with neurodevelopmental disabilities. This term covers a wide range of conditions, from genetic syndromes to brain injuries such as cerebral palsy. Children with neurodevelopmental disabilities often struggle in multiple areas, including language development. While standard speech therapy mainly focuses on understanding and producing words, these children may also have difficulties with the social and communicative skills needed for language. The parent-child relationship is especially important for helping kids develop in their early years.\n\nThis clinical trial aims to find out if an intervention focused on early social and communication skills, and involving parents, can help children with neurodevelopmental disabilities. The study includes children aged 6 months to 5 years. It seeks to answer two key questions:\n\n* Does this intervention improve social and communication skills better than standard speech therapy?\n* Does this intervention affect how parents interact with their child?\n\nTo find the answers, the study will compare two groups: one group will get the parent-involved intervention that focuses on early communication skills, while the other group will get standard speech therapy.\n\nIn the first intervention, therapists will guide parents in observing and supporting their child's social and communication behaviors during various activities like playtime and snack time. In contrast, the standard speech therapy will focus on traditional goals, such as improving the child's ability to vocalize, understand, and use words, without involving parents.\n\nBoth interventions will follow the same schedule-eight weekly sessions, each lasting 45 minutes, over two months.\n\nBefore and after the interventions, the children and parents will:\n\n* Have an assessment of the child's language, social, and communication development.\n* Participate in a 10-minute video recording of parent-child playtime, which will be used to study parenting behavior.",[190,191,192,193,194],"Neurological Impairments","Genetic Syndrome","Neurodevelopmental Disability","Developmental Delays","Language Development Disorders",[196,197,198,199,200,201,202],"Socio-communicative skills","early intervention","Speech therapy","Parenting","Parental support","Intersubjectivity","Neurodevelopmental disabilities","2025-11-18",{"date":205,"type":206},"2025-11-24","ACTUAL",{"date":208,"type":206},"2025-03-19",{"date":210,"type":184},"2026-09-01",{"name":5,"class":6},9]