Autism Spectrum DisorderNCT06913751
Impact of Air Quality on the Effectiveness of Standard of Care Therapy in Children With Autism Spectrum Disorder: A Prospective Longitudinal Study
An observational study of Autism Spectrum Disorder, run by All India Institute of Medical Sciences.
Trial summary
1. Air quality is a growing concern for health and environment and is one of the modifiable environmental factors. There is growing evidence that a complex interplay of genetic and epigenetic factors like environmental factors, underlies the pathophysiology of ASD. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Sep 2026
- Phase
- Observational
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: 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
Who may be able to join
None listed.
Who cannot join
- Other known secondary causes of ASD like Fragile-X Syndrome, Down Syndrome, Tuberous sclerosis, etc.
- ASD with known metabolic disorders
- ASD with drug refractory epilepsy
- -
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
- Air quality is a growing concern for health and environment and is one of the modifiable environmental factors. There is growing evidence that a complex interplay of genetic and epigenetic factors like environmental factors, underlies the pathophysiology of ASD. Behavioural issues, sleep habits and cognitive abilities play a significant role in the quality of life of both the affected children and their caregivers
- Few studies have shown that there is an increased incidence of ASD in children born to mothers exposed to higher levels of air pollution in pregnancy. However, no studies on the effect of air quality on the severity of autism. There are limited studies on the association of air pollution with childhood behaviour and cognitive abilities, especially in neurodevelopmental disorders. No evidence on the impact of air quality on the effectiveness of therapy/standard of care in children with autism, as well as on their sleep habits and behaviour.
Our study aims to add to this growing body of evidence of the effect of air pollution on ASD in children.
Read the detailed description
- All Children with ASD aged 3-12 years attending pediatric neurology OPD and autism clinic will be screened for eligibility.
- Those children fulfilling the inclusion and exclusion criteria will be enrolled into the study.
- First group of children will be enrolled in the month of April 2025 and followed up for a period of 6 months during which the air pollution levels are lower (Average AQI <200) (April to September 2025), following which the primary assessment will be done in the end of September 2025 and then subsequently followed up again for another 6 months. At the end of 1 year, i.e. in the end of March 2026, they will undergo secondary assessment.
- Second group of children will be enrolled in the month of October 2025 and followed up for a period of 6 months during which the air pollution levels are higher (Average AQI >200) (October to March 2026), following which the primary assessment will be done in the end of March 2026 and then subsequently followed up again for another 6 months. At the end of 1 year, i.e. in the end of September 2026, they will undergo secondary assessment.
- Matching of both groups: Both the groups will be matched for all possible confounders
- Age
- Gender
- Socioeconomic status
- Household fuel
- Severity of autism
- Any smoker at home
- Cooking method used at home
- Overcrowding
- Use of AC/Cooler/Fan/Heater as appropriate
- BMI
- Other relevant clinical and medical details
- Bias: In order to avoid possible observer bias, the baseline assessment will be done and intervention module will be provided by the primary investigator. The follow up assessments at 6 and 12 months will be done by another DM senior resident from the division of child neurology.
Intervention and management of enrolled patients
- Informed consent will be taken from parents/legally acceptable representatives for the study
- Baseline demographic details and following evaluation will be done - Autism severity assessment using CARS -2 score Cognitive assessment using VABS/DP-3/MISIC Behavioural assessment using CBCL questionnaire Screening for sleep related disorders using CSHQ score Group I- Children with autism spectrum disorder followed up during the months with lower air pollution
- 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.
- Their demographic details including place of residence will be collected at baseline.
- The children will also be evaluated for their baseline CARS score, DQ/SQ/IQ, sleep related disorders and behavioural issues using standardised validated tools as described above.
- 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.
- At the end of 12 month follow up period, the children will again be evaluated for CARS-2 score, DQ/SQ/IQ, sleep related disorders and behavioural issues using standardised validated tools as described above.
- Data on exposure to air pollution (daily average PM 2.5 and PM 10 levels) will be collected for the total follow up period of 1 year based on the nearest air pollution monitoring site of CPCB.
- Those children identified with sleep issues in the CSHQ questionnaire will be managed as per the standard guidelines and will undergo actigraphy and polysomnography as and when warranted.
- In children with behaviour issues, standard of care will be provided in the form of anti-psychotic medications and other behavioural interventions.
Group II- Children with autism spectrum disorder followed up during the months with higher air pollution
- 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.
- Their demographic details including place of residence will be collected at baseline.
- The children will also be evaluated for their baseline CARS score, DQ/SQ/IQ, sleep related disorders and behavioural issues using standardised validated tools as described above.
- 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.
- At the end of 12 month follow up period, the children will again be evaluated for CARS-2 score, DQ/SQ/IQ, sleep related disorders and behavioural issues using standardised validated tools as described above.
- Data on exposure to air pollution(daily average PM 2.5 and PM 10 levels)will be collected for the total follow up period of 1 year based on the nearest air pollution monitoring site of CPCB.
- Those children identified with sleep issues in the CSHQ questionnaire will be managed as per the standard guidelines and will undergo actigraphy and polysomnography as and when warranted.
- In children with behaviour issues, standard of care will be provided in the form of anti-psychotic medications and other behavioural interventions.
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- standard of care
- Keywords
- autism spectrum disorder, Air pollution
- 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.
standard of careBehavioural
standard of care therapy with behavioural and occupational therapy along with other pharmacological therapy as required
| Study group | Role | What they receive |
|---|---|---|
| Children with autism spectrum disorder followed up during the months with lower air pollution | * 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. Receives: Behavioral: standard of care | |
| Children with autism spectrum disorder followed up during the months with higher air pollution | * 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. Receives: Behavioral: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheffali Gulati, All India Institute of Medical Sciences
- Investigators
- sheffali gulati, MD, Principal investigator, All India Institute of Medical Sciences, New Delhi, Delhi 110029
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913751
- Sponsor's protocol ID
- AIIMSA2566
- Status last verified
- Mar 2025
- First submitted
- 31 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Air Quality on the Effectiveness of Standard of Care Therapy in Children With Autism Spectrum Disorder: A Prospective Longitudinal Study
- ClinicalTrials.gov ID
- NCT06913751
- Acronym / sponsor ID
- AIIMSA2566
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism spectrum disorder, Air pollution
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 6 Apr 2025 (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.
- Air quality is a growing concern for health and environment and is one of the modifiable environmental factors. There is growing evidence that a complex interplay of genetic and epigenetic factors like environmental factors, underlies the pathophysiology of ASD. Behavioural issues, sleep habits and cognitive abilities play a significant role in the quality of life of both the affected children and their caregivers
- Few studies have shown that there is an increased incidence of ASD in children born to mothers exposed to higher levels of air pollution in pregnancy. However, no studies on the effect of air quality on the severity of autism. There are limited studies on the association of air pollution with childhood behaviour and cognitive abilities, especially in neurodevelopmental disorders. No evidence on the impact of air quality on the effectiveness of therapy/standard of care in children with autism, as well as on their sleep habits and behaviour.
Our study aims to add to this growing body of evidence of the effect of air pollution on ASD in children.
Detailed description
- All Children with ASD aged 3-12 years attending pediatric neurology OPD and autism clinic will be screened for eligibility.
- Those children fulfilling the inclusion and exclusion criteria will be enrolled into the study.
- First group of children will be enrolled in the month of April 2025 and followed up for a period of 6 months during which the air pollution levels are lower (Average AQI <200) (April to September 2025), following which the primary assessment will be done in the end of September 2025 and then subsequently followed up again for another 6 months. At the end of 1 year, i.e. in the end of March 2026, they will undergo secondary assessment.
- Second group of children will be enrolled in the month of October 2025 and followed up for a period of 6 months during which the air pollution levels are higher (Average AQI >200) (October to March 2026), following which the primary assessment will be done in the end of March 2026 and then subsequently followed up again for another 6 months. At the end of 1 year, i.e. in the end of September 2026, they will undergo secondary assessment.
- Matching of both groups: Both the groups will be matched for all possible confounders
- Age
- Gender
- Socioeconomic status
- Household fuel
- Severity of autism
- Any smoker at home
- Cooking method used at home
- Overcrowding
- Use of AC/Cooler/Fan/Heater as appropriate
- BMI
- Other relevant clinical and medical details
- Bias: In order to avoid possible observer bias, the baseline assessment will be done and intervention module will be provided by the primary investigator. The follow up assessments at 6 and 12 months will be done by another DM senior resident from the division of child neurology.
Intervention and management of enrolled patients
- Informed consent will be taken from parents/legally acceptable representatives for the study
- Baseline demographic details and following evaluation will be done - Autism severity assessment using CARS -2 score Cognitive assessment using VABS/DP-3/MISIC Behavioural assessment using CBCL questionnaire Screening for sleep related disorders using CSHQ score Group I- Children with autism spectrum disorder followed up during the months with lower air pollution
- 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.
- Their demographic details including place of residence will be collected at baseline.
- The children will also be evaluated for their baseline CARS score, DQ/SQ/IQ, sleep related disorders and behavioural issues using standardised validated tools as described above.
- 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.
- At the end of 12 month follow up period, the children will again be evaluated for CARS-2 score, DQ/SQ/IQ, sleep related disorders and behavioural issues using standardised validated tools as described above.
- Data on exposure to air pollution (daily average PM 2.5 and PM 10 levels) will be collected for the total follow up period of 1 year based on the nearest air pollution monitoring site of CPCB.
- Those children identified with sleep issues in the CSHQ questionnaire will be managed as per the standard guidelines and will undergo actigraphy and polysomnography as and when warranted.
- In children with behaviour issues, standard of care will be provided in the form of anti-psychotic medications and other behavioural interventions.
Group II- Children with autism spectrum disorder followed up during the months with higher air pollution
- 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.
- Their demographic details including place of residence will be collected at baseline.
- The children will also be evaluated for their baseline CARS score, DQ/SQ/IQ, sleep related disorders and behavioural issues using standardised validated tools as described above.
- 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.
- At the end of 12 month follow up period, the children will again be evaluated for CARS-2 score, DQ/SQ/IQ, sleep related disorders and behavioural issues using standardised validated tools as described above.
- Data on exposure to air pollution(daily average PM 2.5 and PM 10 levels)will be collected for the total follow up period of 1 year based on the nearest air pollution monitoring site of CPCB.
- Those children identified with sleep issues in the CSHQ questionnaire will be managed as per the standard guidelines and will undergo actigraphy and polysomnography as and when warranted.
- In children with behaviour issues, standard of care will be provided in the form of anti-psychotic medications and other behavioural interventions.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with autism spectrum disorder followed up during the months with lower air pollution | – | Behavioral: standard of care* 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. |
| Children with autism spectrum disorder followed up during the months with higher air pollution | – | 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. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Other known secondary causes of ASD like Fragile-X Syndrome, Down Syndrome, Tuberous sclerosis, etc.
- ASD with known metabolic disorders
- ASD with drug refractory epilepsy
- -
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 |
|---|---|---|
| standard of carestandard of care therapy with behavioural and occupational therapy along with other pharmacological therapy as required | Behavioural | Children with autism spectrum disorder followed up during the months with higher air pollution, Children with autism spectrum disorder followed up during the months with lower air pollution |
Primary outcome
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
Time frame: 6 months
Difference in the change in mean CARS score between the two groups at 6 months follow up
6 secondary outcomes
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
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
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
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
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
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
Time frame: 6 months
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 6 Apr 2025.
- Individual participant dataSharing planned: No
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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.
sheffali gulati, MD principal investigator
All India Institute of Medical Sciences, New Delhi, Delhi 110029
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by All India Institute of Medical Sciences.
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 0 inclusion and 4 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 6 Apr 2025. 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 sheffali gulati, MD (01126594679, sheffaligulati@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2025.