About this trial
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. Behavioural issues, sleep habits and cognitive abilities play a significant role in the quality of life of both the affected children and their caregivers 2. 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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
Trial design
Other
Prospective
Treatments tested in this trial
standard of care
Behavioralstandard of care therapy with behavioural and occupational therapy along with other pharmacological therapy as required
Treatment groups
Trial outcomes
Primary outcomes
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
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
Difference in the change in mean CARS score between the two groups at 12 months follow up
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
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
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
Locations
Sponsors and contacts
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