NCT06666777 Speech Therapy and Parenting for Early Socio-communicAtive sKills

Eligibility & Interventions

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This trial targets 60 participants in total. It began in 2025-03-19 with a primary completion date of 2026-07-31.

Brief Summary

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 improve social and communication skills better than standard speech therapy? * Does this intervention affect how parents interact with their child? To 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. In 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. Both interventions will follow the same schedule-eight weekly sessions, each lasting 45 minutes, over two months. Before and after the interventions, the children and parents will: * Have an assessment of the child's language, social, and communication development. * Participate in a 10-minute video recording of parent-child playtime, which will be used to study parenting behavior.

Eligibility Criteria

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 (≥ 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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