NCT07858383Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 188 (estimated)
- First submitted
- 29 Sept 2026
- Start date
- 15 Jan 2027
- Primary completion date
- 14 Dec 2027
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Diseases
- Autism
- NCT number
- NCT07858383
What you commit to
- Study type: Interventional
- Planned participants: 188
- From 15 Jan 2027 to the primary completion date, 14 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe or profound intellectual disability \[threshold and instrument\] Uncontrolled epilepsy or another medical condition that precludes participation Uncorrected severe visual or hearing impairment Caregiver with a severe mental illness or other condition that would prevent delivery of the module Current enrolment in another structured parent-training programme Plans to leave the catchment area within 6 months
Who the study is looking for
- Child aged 2-9 years Diagnosis of autism spectrum disorder according to ICD-11 criteria, made by a psychiatrist after clinical evaluation and supported by the INCLEN Diagnostic Tool for ASD \[or ISAA - TO CONFIRM\] A primary caregiver (biological parent, legal guardian or family member responsible for most daily care) aged 18 years or older who is willing and able to attend coaching sessions, take part in telephone follow-up and practise activities at home for 12 weeks Access to a mobile telephone Written informed consent from the caregiver or legally authorised representative
Age in the registry: 2 years to 15 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.