Actively Recruiting
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
Eligibility Criteria
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
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
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
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
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