Autism Spectrum DisorderNCT07858383
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
A study testing Behavioral: PRIME-ASD (Parent-led Intervention Module for Early Autism Spectrum Disorder) and Behavioral: PRIME-ASD; Other: Treatment as usual in people with Autism Spectrum Disorder, run by All India Institute of Medical Sciences, Bhubaneswar.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Behavioral: PRIME-ASD (Parent-led Intervention Module for Early Autism Spectrum Disorder) and Behavioral: PRIME-ASD; Other: Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2027to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Behavioral: PRIME-ASD (Parent-led Intervention Module for Early Autism Spectrum Disorder), Behavioral: PRIME-ASD; Other: Treatment as usual
- Keywords
- autism spectrum disorder, parent-mediated intervention, caregiver coaching, early intervention, home-based intervention, Indian Scale for Assessment of Autism
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: PRIME-ASD (Parent-led Intervention Module for Early Autism Spectrum Disorder)Behavioural
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 usualBehavioural
Children continue treatment as usual alone, without restriction.
| Study group | Role | What they receive |
|---|---|---|
| PRIME-ASD plus treatment as usual - Experimental | Experimental | Children and their primary caregivers receive the 12-week PRIME-ASD parent-led intervention in addition to treatment as usual. Receives: Behavioral: Behavioral: PRIME-ASD (Parent-led Intervention Module for Early Autism Spectrum Disorder) |
| Behavioral: PRIME-ASD; Other: Treatment as usual | Active comparator | Children continue treatment as usual alone, without restriction. Receives: Behavioral: Behavioral: PRIME-ASD; Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Secondary outcomes (7)
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.
Measured: Baseline and 24 weeks
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
Measured: Baseline, 12 weeks and 24 weeks
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.
Measured: Baseline, 12 weeks and 24 weeks
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.
Measured: 12 weeks and 24 weeks
Feasibility of the intervention
Recruitment rate, retention, session attendance, home-practice adherence and intervention fidelity, reported as proportions with 95% CI or median (IQR).
Measured: Enrolment to 24 weeks
Acceptability of the intervention
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).
Measured: 12 weeks
Number of participants with adverse events and serious adverse events
Adverse events and serious adverse events by arm, severity and relatedness, from caregiver report and clinician review.
Measured: Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start15 Jan 2027 (estimated)
- Primary completion14 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group, superiority randomised controlled trial with 1:1 allocation of PRIME-ASD plus treatment as usual versus treatment as usual alone, with an embedded qualitative study in the intervention arm.
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Debadatta Mohapatra, All India Institute of Medical Sciences, Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858383
- Sponsor's protocol ID
- PhD Thesis/2025/03
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 23633377Nevill 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.
PubMed 29490483Green 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.
PubMed 20494434Rahman 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.
PubMed 26704571Mukherjee 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.
PubMed 25848996Juneja 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.
PubMed 24953575
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07858383
- Acronym / sponsor ID
- PhD Thesis/2025/03
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism spectrum disorder, parent-mediated intervention, caregiver coaching, early intervention, home-based intervention, Indian Scale for Assessment of Autism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 14 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group, superiority randomised controlled trial with 1:1 allocation of PRIME-ASD plus treatment as usual versus treatment as usual alone, with an embedded qualitative study in the intervention arm.
| Arm | Type | Receives |
|---|---|---|
| PRIME-ASD plus treatment as usual - Experimental | Experimental | Behavioral: Behavioral: PRIME-ASD (Parent-led Intervention Module for Early Autism Spectrum Disorder)Children and their primary caregivers receive the 12-week PRIME-ASD parent-led intervention in addition to treatment as usual. |
| Behavioral: PRIME-ASD; Other: Treatment as usual | Active comparator | Behavioral: Behavioral: PRIME-ASD; Other: Treatment as usualChildren continue treatment as usual alone, without restriction. |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | PRIME-ASD plus treatment as usual - Experimental |
| Behavioral: PRIME-ASD; Other: Treatment as usualChildren continue treatment as usual alone, without restriction. | Behavioural | Behavioral: PRIME-ASD; Other: Treatment as usual |
Primary outcome
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.
7 secondary outcomes
Maintenance of change in ISAA total score
Time frame: Baseline and 24 weeks
Change in ISAA domain scores
Time frame: Baseline, 12 weeks and 24 weeks
Change in behavioural symptoms (Aberrant Behavior Checklist-Community)
Time frame: Baseline, 12 weeks and 24 weeks
Proportion of responders
Time frame: 12 weeks and 24 weeks
Feasibility of the intervention
Time frame: Enrolment to 24 weeks
Acceptability of the intervention
Time frame: 12 weeks
Number of participants with adverse events and serious adverse events
Time frame: Baseline to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Results publication: PubMed 23633377Oono 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.
- Results publication: PubMed 29490483Nevill 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.
- Results publication: PubMed 20494434Green 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.
- Results publication: PubMed 26704571Rahman 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.
- Results publication: PubMed 25848996Mukherjee 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.
- Results publication: PubMed 24953575Juneja 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: PRIME-ASD (Parent-led Intervention Module for Early Autism Spectrum Disorder) and Behavioral: PRIME-ASD; Other: Treatment as usual in people with Autism Spectrum Disorder, run by All India Institute of Medical Sciences, Bhubaneswar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sahadeb Panigrahi, MD (07978517101, sahadebpanigrahi18@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in autism symptom severity (ISAA total score) at 12 weeks (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07858383, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.