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.
Study Overview
Status
Conditions
Detailed Description
Background. Parent-mediated interventions improve parent-child interaction and show smaller but consistent benefits for child social communication. Existing Indian adaptations were developed in other linguistic and service contexts and have not been co-designed with Odia-speaking families or aligned with the District Early Intervention Centres (DEIC) through which Odisha delivers early developmental services.
Development. PRIME-ASD was developed in earlier phases of a multiphase mixed-methods study: a systematic review and meta-analysis of randomised trials of parent-mediated interventions (registered with PROSPERO); in-depth interviews and focus groups with caregivers, providers and administrators; and a modified Delphi process (8-12 experts; consensus ≥80%) with content validation (I-CVI ≥0.78; S-CVI/Ave ≥0.80), face validation with 6-8 parents and field testing with 3-5 parent-child dyads. This record covers only the randomised controlled trial.
Design. Two-arm, parallel-group, open-label, assessor-blinded, superiority randomised controlled trial with 1:1 allocation and an embedded qualitative study, reported according to SPIRIT 2013 and CONSORT. Allocation uses a computer-generated sequence of randomly permuted blocks of variable size [2, 4 and 6], prepared by an independent statistician and concealed in sequentially numbered, opaque, sealed envelopes opened after the baseline assessment.
Intervention. PRIME-ASD comprises 12 weekly individual coaching sessions of about [60] minutes (didactic coaching, demonstration, coached caregiver-child practice with feedback and home-goal setting), weekly telephone follow-up of about [15-20] minutes and daily home practice of about [20-30] minutes across six domains aligned with the ISAA. Sessions are delivered in person at AIIMS Bhubaneswar, with synchronous video sessions when travel is not possible. Fidelity is monitored with attendance logs, home-practice checklists, an interventionist fidelity checklist and supervisor rating of [20%] of audio-recorded sessions.
Comparator. Treatment as usual (TAU): routine outpatient psychiatric review, psychoeducation and counselling, medication where clinically indicated and referral to available therapy services. TAU is not restricted in either arm, and co-interventions are recorded at each assessment.
Sample size. Assuming a standardised mean difference of 0.45 in ISAA score, two-sided α = 0.05 and 80% power, 79 children per arm are required; allowing for 15% attrition by 24 weeks, 94 per arm (188 in total) will be recruited.
Analysis. Intention to treat. The 12-week ISAA total score will be compared with analysis of covariance adjusted for baseline score [and any stratification factors]. Secondary outcomes will be analysed with linear mixed-effects models (arm, time, arm-by-time and baseline score) and logistic regression for response, without adjustment for multiplicity. Missing data will be handled by multiple imputation by chained equations, with complete-case, per-protocol and tipping-point sensitivity analyses. No interim efficacy analysis is planned.
Embedded qualitative study. After the 12-week assessment, approximately [15-20] intervention-arm caregivers, sampled on adherence and ISAA change, and the interventionists will be interviewed; findings will be merged with trial results in joint displays.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sahadeb Panigrahi, MD
- Phone Number: 07978517101
- Email: sahadebpanigrahi18@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PRIME-ASD plus treatment as usual - Experimental
Children and their primary caregivers receive the 12-week PRIME-ASD parent-led intervention in addition to treatment as usual. |
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. |
|
Active Comparator: Behavioral: PRIME-ASD; Other: Treatment as usual
Children continue treatment as usual alone, without restriction. |
Children continue treatment as usual alone, without restriction. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in autism symptom severity (ISAA total score) at 12 weeks
Time Frame: Baseline and 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. |
Baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maintenance of change in ISAA total score
Time Frame: Baseline and 24 weeks
|
ISAA total score (40-200; higher scores indicate greater severity), masked clinician rating; adjusted mean difference from a linear mixed-effects model. |
Baseline and 24 weeks
|
|
Change in ISAA domain scores
Time Frame: Baseline, 12 weeks and 24 weeks
|
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 |
Baseline, 12 weeks and 24 weeks
|
|
Change in behavioural symptoms (Aberrant Behavior Checklist-Community)
Time Frame: Baseline, 12 weeks and 24 weeks
|
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. |
Baseline, 12 weeks and 24 weeks
|
|
Proportion of responders
Time Frame: 12 weeks and 24 weeks
|
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. |
12 weeks and 24 weeks
|
|
Feasibility of the intervention
Time Frame: Enrolment to 24 weeks
|
Recruitment rate, retention, session attendance, home-practice adherence and intervention fidelity, reported as proportions with 95% CI or median (IQR). |
Enrolment to 24 weeks
|
|
Acceptability of the intervention
Time Frame: 12 weeks
|
Caregiver-rated Acceptability of Intervention Measure, Intervention Appropriateness Measure and Feasibility of Intervention Measure (each scored 1-5; higher scores indicate greater acceptability, appropriateness or feasibility). |
12 weeks
|
|
Number of participants with adverse events and serious adverse events
Time Frame: Baseline to 24 weeks
|
Adverse events and serious adverse events by arm, severity and relatedness, from caregiver report and clinician review. |
Baseline to 24 weeks
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Oono IP, Honey EJ, McConachie H. Parent-mediated early intervention for young children with autism spectrum disorders (ASD). Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD009774. doi: 10.1002/14651858.CD009774.pub2.
- Nevill RE, Lecavalier L, Stratis EA. Meta-analysis of parent-mediated interventions for young children with autism spectrum disorder. Autism. 2018 Feb;22(2):84-98. doi: 10.1177/1362361316677838. Epub 2016 Nov 14.
- Green J, Charman T, McConachie H, Aldred C, Slonims V, Howlin P, Le Couteur A, Leadbitter K, Hudry K, Byford S, Barrett B, Temple K, Macdonald W, Pickles A; PACT Consortium. Parent-mediated communication-focused treatment in children with autism (PACT): a randomised controlled trial. Lancet. 2010 Jun 19;375(9732):2152-60. doi: 10.1016/S0140-6736(10)60587-9. Epub 2010 May 20.
- Rahman A, Divan G, Hamdani SU, Vajaratkar V, Taylor C, Leadbitter K, Aldred C, Minhas A, Cardozo P, Emsley R, Patel V, Green J. Effectiveness of the parent-mediated intervention for children with autism spectrum disorder in south Asia in India and Pakistan (PASS): a randomised controlled trial. Lancet Psychiatry. 2016 Feb;3(2):128-36. doi: 10.1016/S2215-0366(15)00388-0. Epub 2015 Dec 17.
- Mukherjee SB, Malhotra MK, Aneja S, Chakraborty S, Deshpande S. Diagnostic accuracy of Indian Scale for Assessment of Autism (ISAA) in chidren aged 2-9 years. Indian Pediatr. 2015 Mar 8;52(3):212-6. doi: 10.1007/s13312-015-0608-z.
- Juneja M, Mishra D, Russell PS, Gulati S, Deshmukh V, Tudu P, Sagar R, Silberberg D, Bhutani VK, Pinto JM, Durkin M, Pandey RM, Nair MK, Arora NK; INCLEN Study Group. INCLEN Diagnostic Tool for Autism Spectrum Disorder (INDT-ASD): development and validation. Indian Pediatr. 2014 May;51(5):359-65. doi: 10.1007/s13312-014-0417-9.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PhD Thesis/2025/03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.