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.
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
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
Parallel
Behavioral: PRIME-ASD (Parent-led Intervention Module for Early Autism Spectrum Disorder)
BehavioralTwelve 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
BehavioralChildren continue treatment as usual alone, without restriction.
Change in autism symptom severity (ISAA total score) at 12 weeks
Indian Scale for Assessment of Autism (ISAA) total score, rated by a masked clinician. 40 items scored 1-5; total 40-200; higher scores indicate greater severity (lower is better). Between-arm adjusted mean difference with 95% CI, analysis of covariance adjusted for baseline score.
Maintenance of change in ISAA total score
ISAA total score (40-200; higher scores indicate greater severity), masked clinician rating; adjusted mean difference from a linear mixed-effects model.
Change in ISAA domain scores
Scores on the six ISAA domains (social relationship and reciprocity; emotional responsiveness; speech, language and communication; behaviour patterns; sensory aspects; cognitive component); higher scores indicate greater severity
Change in behavioural symptoms (Aberrant Behavior Checklist-Community)
Caregiver-rated ABC-C total and five subscale scores (irritability; social withdrawal; stereotypic behaviour; hyperactivity/non-compliance; inappropriate speech); 58 items; higher scores indicate more problem behaviour.
Proportion of responders
Percentage of children with an ISAA reduction of at least 0.5 SD of the baseline score and, separately, a VSMS gain of at least 0.3 SD; adjusted odds ratio with 95% CI.
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