Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
Sponsor: All India Institute of Medical Sciences, Bhubaneswar
Summary
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.
Key Details
Gender
All
Age Range
2 Years - 15 Years
Study Type
INTERVENTIONAL
Enrollment
188
Start Date
2027-01-15
Completion Date
2027-12-15
Last Updated
2026-10-05
Healthy Volunteers
No
Conditions
Interventions
Behavioral: PRIME-ASD (Parent-led Intervention Module for Early Autism Spectrum Disorder)
Twelve weekly individual coaching sessions of about \[60\] minutes with a caregiver-child dyad, delivered by a \[clinical psychologist / trained research therapist\] in person at AIIMS Bhubaneswar or by synchronous video. Each session includes brief didactic coaching, live or video demonstration, coached caregiver-child practice with feedback and collaborative home-goal setting. Caregivers practise play-based routines at home for about \[20-30\] minutes daily across six domains (social relationship and reciprocity; emotional responsiveness; speech, language and communication; behaviour patterns; sensory aspects; cognitive component) and receive a weekly telephone follow-up of about \[15-20\] minutes. Materials include an Odia-language manual, parent handouts, daily activity checklists and demonstration videos.
Behavioral: PRIME-ASD; Other: Treatment as usual
Children continue treatment as usual alone, without restriction.