Impact of Air Quality on the Effectiveness of Standard of Care Therapy in Children With Autism Spectrum Disorder: A Prospective Longitudinal Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-12
SponsorAll India Institute of Medical Sciences

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • standard of care

    Behavioral

    standard of care therapy with behavioural and occupational therapy along with other pharmacological therapy as required

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Children with autism spectrum disorder followed up during the months with lower air pollution1 intervention
Group B: Children with autism spectrum disorder followed up during the months with higher air pollution1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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