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

Abstract

Introduction 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 sociocommunicative skills in children with NDs. Methods and analysis Sixty children with NDs aged 6 months to 5 years will be randomly assigned to either the intervention group (IG, n=30), receiving a parentinvolved speech therapy intervention focused on sociocommunicative 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 8weeks, with weekly 45min 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. Ethics and dissemination 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 peerreviewed journals and international conferences.