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Speech Therapy and Parenting for Early Socio-communicAtive sKills

Study acronym: SPEAK
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated November 24, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 8 more changesShow less
    • Primary endpoints: 4 to 3
    • Study sites: 8 to 9
    • Primary completion date: Jun 30, 2026 to Jul 31, 2026
    • Study completion date: Jun 30, 2026 to Sep 1, 2026
    • Start date changed from estimate of Jan 15, 2025 to Mar 19, 2025
    • Secondary endpoints: 1 to 4
    • Study description expanded, about 48 words
    • Eligibility criteria shortened, about 2 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06666777
Lead Sponsor IRCCS Eugenio Medea
Collaborators: Associazione La Nostra Famiglia, Como, Italy
Conditions
(from sponsor)
Neurological Impairments, Genetic Syndrome, Neurodevelopmental Disability, Developmental Delays, Language Development Disorders
Related terms Communication Disorders, Genetic Diseases, Inborn, Language Development Disorders
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov