BMJ open · 2025
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.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Porro Chiara, Butti Niccolò, Sacchi Daniela, Rigamonti Roberta, Miccoli Annalisa, Montirosso Rosario, Strazzer Sandra
Аннотация
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 socio-communicative 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 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.
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 peer-reviewed journals and international conferences.
TRIAL REGISTRATION NUMBER: NCT06666777.
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 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.
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 peer-reviewed journals and international conferences.
TRIAL REGISTRATION NUMBER: NCT06666777.