Supporting Parenting at Home-Empowering Rehabilitation through Engagement (SPHERE): study protocol for a randomised control trial.

Abstract

Infants with neurodevelopmental disabilities (NDs) show emotional, cognitive and sociointeractive dysregulation dramatically impacting on caregiving behaviour. Early video-feedback interventions (VFIs) are effective in promoting sensitive parenting, which in turn supports infants' development, even in case of ND. In the light of limited resources of the healthcare systems, technological advances in telemedicine may facilitate the delivery of VFI to a greater number of families of infants with ND. To date, no study has implemented a telemedicine VFI (TVFI) for families of infants diagnosed with ND. The Supporting Parenting at Home-Empowering Rehabilitation through Engagement project is a randomised controlled trial aimed at assessing the effectiveness of an early family-centred TVFI parenting support on dyads with infants diagnosed with ND. It includes two arms (TVFI vs Booklet Psychoeducational Intervention) and three assessment phases: T0, baseline; T1, immediate postintervention; T2, 6-month follow-up. This study is funded by the Italian Ministry of Health and was approved by the Ethics Committee (Pavia). Results will be published in peer-reviewed journals and presented at national and international scientific conferences. The study protocol has been also registered on NIH Clinical Trials (protocol code NCT04656483; Pre-results).