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Speech Therapy and Parenting for Early Socio-communicative Skills in Children With Neurodevelopmental Disabilities

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 4
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Italy
Associazione La Nostra Famiglia - Centro di Riabilitazione Ambulatoriale, Diurno (CDC) e Residenziale
RECRUITING
Bosisio Parini
Associazione La Nostra Famiglia - IRCCS E. Medea
RECRUITING
Bosisio Parini
Associazione La Nostra Famiglia- Centro di Riabilitazione Ambulatoriale
RECRUITING
Carate Brianza
Associazione La Nostra Famiglia- Centro di Riabilitazione Ambulatoriale
RECRUITING
Cislago
Associazione La Nostra Famiglia - Centro di Riabilitazione Ambulatoriale
RECRUITING
Como
Associazione La Nostra Famiglia - Centro di Riabilitazione Ambulatoriale, Diurno (CDC) e Domiciliare
RECRUITING
Lecco
Associazione La Nostra Famiglia - Centro di Riabilitazione Ambulatoriale e Diurno (CDC)
RECRUITING
Ponte Lambro
Associazione La Nostra Famiglia- Centro di Riabilitazione Ambulatoriale
RECRUITING
Sesto San Giovanni
Associazione La Nostra Famiglia- Centro di Riabilitazione Ambulatoriale, Diurno (CDC)
RECRUITING
Vedano Olona
Contact Information
Primary
Sandra Strazzer, M.D.
sandra.strazzer@lanostrafamiglia.it
+39031877854
Backup
Niccolò Butti, Ph.D.
niccolo.butti@lanostrafamiglia.it
+39031877464
Time Frame
Start Date: 2025-03-19
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 60
Treatments
Experimental: Experimental arm involving parents
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.
Active_comparator: Standard speech therapy
Participants in this group will receive standard speech therapy. Parental involvement will only occur if strictly necessary.
Related Therapeutic Areas
Sponsors
Leads: IRCCS Eugenio Medea
Collaborators: Associazione La Nostra Famiglia, Como, Italy

This content was sourced from clinicaltrials.gov