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

NCT06913751 | Not Yet Recruiting

• 1 other identifier: AIIMSA2566
• Study Type: observational
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 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.

Conditions

Autism Spectrum Disorder

Keywords

autism spectrum disorder; Air pollution

Outcome Measures

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

  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

  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

  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

  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

  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

  12 months

Study Arms (2)

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.

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.

Behavioral: standard of care

Interventions

standard of care BEHAVIORAL

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

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

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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

You may not qualify if:

• 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

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Biospecimen

Retention: SAMPLES WITH DNA

Three millilitres of blood sample will be collected from every 5th patient from each group, at the end of 6 months follow up,. 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.

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• sheffali gulati, MD

  All India Institute of Medical Sciences, New Delhi, Delhi 110029

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sheffali gulati, MD

CONTACT

01126594679; sheffaligulati@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 6, 2025
• Study Start: April 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share