An observational study in Autism Spectrum Disorder, sponsored by All India Institute of Medical Sciences, New Delhi. Not yet recruiting. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-04-06.
Sponsored by All India Institute of Medical Sciences, New Delhi · Observational
Our study aims to add to this growing body of evidence of the effect of air pollution on ASD in children.
Matching of both groups: Both the groups will be matched for all possible confounders
Intervention and management of enrolled patients
Group II- Children with autism spectrum disorder followed up during the months with higher air pollution
Blood Sample Analysis for Nuclear Chromatin To assess the gene expression changes due to air pollution, epigenetic mark on histone proteins, a core component of chromatin that needs to be closed or open state for transcriptional changes, can be measured. The H3 trimethylated at lysine 4 (H3K4me3) represents an open chromatin state representing active transcription. Chromatin immunoprecipitation using antibody detecting H3K4me3 followed by sequencing of the DNA fragments (ChIP-Seq) will determine active or poised transcription. Hence, the objective of the study is to perform ChIP-Seq analysis from peripheral blood samples to visualize the global change in transcription. Detection of transcriptional change would lead to further study to assess open vs. closed chromatin state. This will be determined by ATAC-Seq that detects chromatin states and subsequent RNA-Seq from same sample that determine RNA expression level as an indicator of transcription.
Three millilitres of blood sample will be collected from every 5th patient from each group, at the end of 6 months follow up, for the above analysis. Samples will be collected only from those patients who provide consent for the same. A total of 10 samples, 5 from each group will be collected and analysed.
Informed consent Eligible children will be enrolled only after receiving written informed consent from parents/guardian. Parents will be explained about the voluntary nature of participation in the study and the option to withdraw from the study at any point in time.
Ethical considerations Parents or LAR of the eligible children will be approached and explained regarding the study. Only those children whose parents/LAR give written informed consent will be enrolled in the study. The study protocol will be submitted to the AIIMS Institute Ethics Committee for approval and the study will be initiated only after such an approval is received.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 66 is below the median of 102 across 320 observational studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →All India Institute of Medical Sciences, New Delhi is the lead sponsor of 143 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children with ASD based on DSM -V criteria between 3- 12 years of age attending the Pediatric Neurology OPD and Autism clinic, in Department of Pediatrics, at AIIMS, New Delhi
Inclusion Criteria:1. Children aged 3- 12 years diagnosed with ASD according to DSM -V criteria and those who have received standard of care for less than 6 months at the time of screening and enrolment 2. Resident of Delhi-NCR
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Exclusion Criteria:
ASD with drug epilepsy
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* First group of children with autism spectrum disorder who meet the inclusion and exclusion criteria will be enrolled in the study after due informed consent in the month of April 2025. * The children will be followed up for a period of 6 months till September 2025 when they will be evaluated for primary outcome- CARS-2 score and other secondary outcomes-behavioural issues/sleep issues/cognitive ability. * They will further be followed up for the next 6 months till March 2026 to be evaluated for secondary outcomes.
Behavioral: standard of care
* Second group of children with autism spectrum disorder who meet the inclusion and exclusion criteria will be enrolled in the study after due informed consent in the month of October 2025. * The children will be followed up for a period of 6 months till March 2026 when they will be evaluated for primary outcome- CARS-2 score and other secondary outcomes-behavioural issues/sleep issues/cognitive ability. * They will further be followed up for the next 6 months till September 2026 to be evaluated for secondary outcomes.
Behavioral: standard of care
standard of care therapy with behavioural and occupational therapy along with other pharmacological therapy as required
To compare the effectiveness of standard of care therapy, in terms of change in CARS score after 6 months follow up, in two groups of children with autism spectrum disorder, during months with high air pollution and low air pollution, based on AQI
Difference in the change in mean CARS score between the two groups at 6 months follow up
Time frame: 6 months
To compare the effectiveness of standard of care therapy, in terms of change in CARS score after 12 months follow up, in two groups of children with autism spectrum disorder, during months with high air pollution and low air pollution, based on AQI
Difference in the change in mean CARS score between the two groups at 12 months follow up
Time frame: 12 months
To compare the impact on cognitive ability, as measured in terms of change in DQ/SQ/IQ after 6 months follow up, in two groups of children with autism spectrum disorder, during months with high air pollution and low air pollution, based on AQI
Difference in the change in mean DQ/IQ/SQ score between the two groups at 6 and 12 months follow up
Time frame: 12 months
To compare the impact on sleep habits, as measured in terms of change in CSHQ score after 6 months follow up, in two groups of children with autism spectrum disorder, during months with high air pollution and low air pollution, based on AQI
Difference in the change in mean CSHQ score between the two groups at 6 and 12 months follow up
Time frame: 12 months
To compare the impact on behavioral profile, as measured in terms of change in CBCL score after 6 months follow up, in two groups of children with autism spectrum disorder, during months with high air pollution and low air pollution, based on AQI
Difference in the change in mean CSHQ score between the two groups at 6 and 12 months follow up
Time frame: 12 months
To assess the corelation between the air quality parameters (PM2.5, PM10) and the severity of autism spectrum disorder/sleep issues/behavioural issues and cognition at the end of 6 months follow up
Corelation between average PM 2.5, PM 10 levels during the 6 and 12 month follow up period and CARS score/CHSQ score/CBCL score/IQ
Time frame: 12 months
To assess for genetic changes by comparing the global change in transcription, between children receiving standard of care during high pollution months and those receiving during low pollution months
To detect transcriptional change, and compare it between the two groups
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2025; primary completion for Mar 2026, 11 months later.
Of 98 non-industry observational studies under Autism Spectrum Disorder, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 120. This study's planned 11 months is below that.
Counting every sponsor, half of 112 studies reached it within 40 months; a quarter within 26 and three quarters within 120.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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All India Institute of Medical Sciences, New Delhi →