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โ† Trials
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Speech Therapy and Parenting for Early Socio-communicAtive sKills

RecruitingNAAges 6 Months - 59 MonthsAllIRCCS Eugenio Medea
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In plain words

What the trial is, and whether it could suit you

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. This 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: * Does this intervention i

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: For children: * Age between 6 months (corrected age in cases of prematurity) and 5 years. * Documented developmental delay and/or socio-communicative difficulties, based on clinical signs or standardized developmental scales (e.g., Griffiths Scales). * Mental age of at least 6 months. * Diagnosis of neurodevelopmental disability, including cerebral palsy, genetic syndromes, rare diseases with non-progressive neurological impairments, or congenital disorders of undetermined nature. For parents: * Adult age (โ‰ฅ 18 yo) * Good knowledge and fluency in Italian. * No manifest psychiatric conditions. * No documented intellectual disability. Exclusion criteria: For children: * Age greater than 5 years at the time of recruitment. * Mental age below 6 months. * Absence of developmental delay (developmental quotient \> 85) and socio-communicative difficulties. * Diagnosis of neurodevelopmental disability resulting from neurodegenerative diseases or brain tumor outcomes. * Severe sensory impairments (profound deafness and/or blindness). For Parents: * Inability to speak Italian. * Documented psychiatric conditions or intellectual disability.
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What it tests

  • Intervention focused on intersubjective prelinguistic and socio-communicative skills
  • Standard speech therapy intervention
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Where

9 sites
Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale
Como, Italy
Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale e Diurno (CDC)
Ponte Lambro, Italy
Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale, Diurno (CDC) e Residenziale
Bosisio Parini, Italy
Associazione La Nostra Famiglia - IRCCS E. Medea
Bosisio Parini, Italy
Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale, Diurno (CDC) e Domiciliare
Lecco, Italy
Associazione "La Nostra Famiglia"- Centro di Riabilitazione Ambulatoriale
Sesto San Giovanni, Italy
Associazione "La Nostra Famiglia"- Centro di Riabilitazione Ambulatoriale
Carate Brianza, Italy
Associazione "La Nostra Famiglia"- Centro di Riabilitazione Ambulatoriale
Cislago, Italy

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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