NCT06666777: SPEAK

Speech Therapy and Parenting for Early Socio-communicAtive sKills

Recruiting now NA Last updated 24 November 2025

What this trial tests

NA trial testing Intervention focused on intersubjective prelinguistic and socio-communicative skills in Neurological Impairments in 60 participants. Currently enrolling.

Timeline

19 March 2025

Primary endpoint
31 July 2026

1 September 2026

Quick facts

Lead sponsor	IRCCS Eugenio Medea
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	19 March 2025
Primary completion	31 July 2026
Estimated completion	1 September 2026
Sites	9 locations across Italy

Drugs / interventions tested

• Intervention focused on intersubjective prelinguistic and socio-communicative skills
• Standard speech therapy intervention

Conditions studied

• Neurological Impairments — all drugs for Neurological Impairments →
• Genetic Syndrome — all drugs for Genetic Syndrome →
• Neurodevelopmental Disability — all drugs for Neurodevelopmental Disability →
• Developmental Delays — all drugs for Developmental Delays →

Sponsor

IRCCS Eugenio Medea — full company profile →

Who can join

Adults 6 Months to 59 Months, any sex, with Neurological Impairments or Genetic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Speech therapy and parenting for early socio-communicative skills in young children with neurodevelopmental disabilities (SPEAK): study protocol for an Italian multicentre randomised controlled trial.
   Porro C, Butti N, Sacchi D, Rigamonti R, et al · · 2025 · PMID 41193214 · DOI 10.1136/bmjopen-2025-102104