Development and Evaluation of a Parent-led Intervention Module for Early Autism Spectrum Disorder (PRIME-ASD) in Odisha, India: Protocol for a Multiphase Mixed-methods Study Including an Open-label Randomised Controlled Trial

Many families of young children with autism in India wait a long time for a diagnosis and specialist therapy, and receive little structured guidance on how to help their child at home. PRIME-ASD is a 12-week programme in which a trained therapist coaches parents or other main caregivers to use simple, play-based activities within everyday household and cultural routines to support their child's social interaction, communication, emotions, behaviour, sensory responses and thinking skills. This study will test whether PRIME-ASD, added to usual care, reduces autism symptoms more than usual care alone. A total of 188 children aged 2-9 years with autism attending AIIMS Bhubaneswar, Odisha, India, will be randomly assigned in equal numbers to receive PRIME-ASD plus usual care or usual care alone. Autism symptoms will be measured with the Indian Scale for Assessment of Autism (ISAA) by assessors who do not know which group the child is in. The main comparison is at 12 weeks; the study will also look at behaviour, social maturity, whether any benefit lasts to 24 weeks, whether families can take part and find the programme acceptable, and safety. Some caregivers will be interviewed about their experience of delivering the programme at home.