Early social-communication therapy with parent coaching for young children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial enrolls children aged 6 months to 5 years who have a diagnosed neurodevelopmental disability and documented developmental delay or socio-communicative difficulties. Participants are assigned to a parent-involved intervention targeting intersubjective prelinguistic and socio-communicative skills or to standard speech therapy, with sessions delivered at regional rehabilitation centers. The intervention combines therapist-led techniques and parent coaching to support early attention, emotional coordination, and joint attention behaviors that underpin later language. Outcomes focus on changes in social-communication, parent–child interaction, and early language measures over the treatment period.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Sandra Strazzer, M.D.
• Email: sandra.strazzer@lanostrafamiglia.it
• Phone: +39031877854

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.