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Early social-communication therapy with parent coaching for young children

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

Not applicable Interventional IRCCS Eugenio Medea · NCT06666777

This study tests whether a parent-involved program that teaches early social and communication skills helps children aged 6 months to 5 years with neurodevelopmental disabilities more than standard speech therapy.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment60 (estimated)
Ages6 Months to 59 Months
SexAll
SponsorIRCCS Eugenio Medea Academic / other
Locations9 sites (Como, Como and 8 other locations)
Trial IDNCT06666777 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children aged 6 months to 5 years with a neurodevelopmental disability and documented developmental delay or socio-communicative difficulties, whose caregivers are adults fluent in Italian and without major psychiatric or intellectual disability, are ideal candidates.

Not a fit: Children without developmental delay or socio-communicative difficulties, those with neurodegenerative conditions or mental age below 6 months, or families unable to participate in Italian-language parent coaching are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, the program could help children develop stronger early social and communication skills and improve parent–child interaction, supporting later language development.

How similar studies have performed: Parent-mediated early interventions have shown benefits for social-communication and language in conditions such as autism, but applying these approaches across a broad range of neurodevelopmental disabilities has been less well studied.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Como, Como and 8 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Neurological ImpairmentsGenetic SyndromeNeurodevelopmental DisabilityDevelopmental DelaysLanguage Development DisordersSocio-communicative skillsearly interventionSpeech therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.