Speech Therapy and Parenting for Early Socio-communicAtive sKills

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.

NCT Number	NCT06666777
Lead Sponsor	IRCCS Eugenio Medea Collaborators: Associazione La Nostra Famiglia, Como, Italy
Conditions	Neurological Impairments, Genetic Syndrome, Neurodevelopmental Disability, Developmental Delays, Language Development Disorders
Enrollment	60 participants
Start Date	2025-03-19
Primary Completion	2026-07-31 (estimated)
Study Completion	2026-09-01 (estimated)
Updated on ClinicalTrials.gov	2025-11-24