Actively Recruiting

Phase Not Applicable
Age: 6Months - 59Months
All Genders
NCT06666777

Speech Therapy and Parenting for Early Socio-communicAtive sKills

Led by IRCCS Eugenio Medea · Updated on 2025-11-24

60

Participants Needed

9

Research Sites

75 weeks

Total Duration

On this page

Sponsors

I

IRCCS Eugenio Medea

Lead Sponsor

A

Associazione La Nostra Famiglia, Como, Italy

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Speech Therapy and Parenting for Early Socio-communicAtive sKills

Who Can Participate

Age: 6Months - 59Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child aged between 6 months (corrected for prematurity) and 5 years
  • Documented developmental delay and/or socio-communicative difficulties based on clinical signs or standardized scales
  • Child has a 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
  • Parent is an adult aged 18 years or older
  • Parent has good knowledge and fluency in Italian
  • Parent has no manifest psychiatric conditions
  • Parent has no documented intellectual disability
Not Eligible

You will not qualify if you...

  • Child older than 5 years at recruitment
  • Child with mental age below 6 months
  • Child without developmental delay (developmental quotient above 85) and no socio-communicative difficulties
  • Child diagnosed with neurodegenerative diseases or brain tumor outcomes
  • Child with severe sensory impairments such as profound deafness or blindness
  • Parent unable to speak Italian
  • Parent with documented psychiatric conditions or intellectual disability

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 9 locations

1

Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale

Como, Como, Italy, 22100

Actively Recruiting

2

Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale e Diurno (CDC)

Ponte Lambro, Como, Italy, 22037

Actively Recruiting

3

Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale, Diurno (CDC) e Residenziale

Bosisio Parini, Lecco, Italy, 23842

Actively Recruiting

4

Associazione La Nostra Famiglia - IRCCS E. Medea

Bosisio Parini, Lecco, Italy, 23842

Actively Recruiting

5

Associazione "La Nostra Famiglia" - Centro di Riabilitazione Ambulatoriale, Diurno (CDC) e Domiciliare

Lecco, Lecco, Italy, 23900

Actively Recruiting

6

Associazione "La Nostra Famiglia"- Centro di Riabilitazione Ambulatoriale

Sesto San Giovanni, Milano, Italy, 20099

Actively Recruiting

7

Associazione "La Nostra Famiglia"- Centro di Riabilitazione Ambulatoriale

Carate Brianza, Monza E Brianza, Italy, 20841

Actively Recruiting

8

Associazione "La Nostra Famiglia"- Centro di Riabilitazione Ambulatoriale

Cislago, Varese, Italy, 21040

Actively Recruiting

9

Associazione "La Nostra Famiglia"- Centro di Riabilitazione Ambulatoriale, Diurno (CDC)

Vedano Olona, Varese, Italy, 21040

Actively Recruiting

Loading map...

Research Team

S

Sandra Strazzer, M.D.

CONTACT

N

Niccolò Butti, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here