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

Neurodevelopmental disabilities (NDs) affect early communication, social engagement and parent-child interactions. Children with NDs often struggle with prelinguistic skills, such as maintaining eye contact and using gestures, which are essential for language development. Parenting behaviour plays a key role in fostering these abilities, and early interventions involving parents can enhance socio-communicative and linguistic outcomes. The present multicentred randomised controlled trial evaluates the effectiveness of a parent-involved speech therapy intervention in improving early socio-communicative skills in children with NDs.

Sixty children with NDs aged 6 months to 5 years will be randomly assigned to either the intervention group (IG, n=30), receiving a parent-involved speech therapy intervention focused on socio-communicative skills, or the control group (CG, n=30), receiving care-as-usual speech therapy. Participants will be recruited from eight rehabilitation centres in Lombardy, Italy. Both interventions will last 8 weeks, with weekly 45 min sessions led by trained speech therapists. Primary outcomes include early communication and intersubjective skills and parenting behaviour, assessed at baseline (T0) and post-intervention (T2-2 months from enrolment). Socio-cognitive skills and socio-emotional development will be considered as secondary outcomes. Feasibility and potential confounders (eg, parental stress) will be measured and controlled between groups.

The study has received formal approval by the deputed ethical committee for all eight participant centres (Comitato Etico Lombardia 2 - Protocol n. R1916/24 - L2-109). Results of the main trial and of the exploratory aims will be submitted for publication in peer-reviewed journals and international conferences.

NCT06666777.