[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586313":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":10,"responsibleParty":34,"collaborators":10,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":41,"acronym":10,"eligibilityCriteria":42,"healthyVolunteers":39,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":10,"studyType":49,"phases":10,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":56,"whyStopped":10,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":10},{"fullName":5,"class":6},"All India Institute of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Children with autism spectrum disorder followed up during the months with lower air pollution",null,"* 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.\n* 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\u002Fsleep issues\u002Fcognitive ability.\n* They will further be followed up for the next 6 months till March 2026 to be evaluated for secondary outcomes.",[13],"Behavioral: standard of care",{"label":15,"type":10,"description":16,"interventionNames":17},"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.\n* 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\u002Fsleep issues\u002Fcognitive ability.\n* They will further be followed up for the next 6 months till September 2026 to be evaluated for secondary outcomes.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"BEHAVIORAL","standard of care","standard of care therapy with behavioural and occupational therapy along with other pharmacological therapy as required",[15,9],[25],{"name":26,"affiliation":27,"role":28},"sheffali gulati, MD","All India Institute of Medical Sciences, New Delhi, Delhi 110029","PRINCIPAL_INVESTIGATOR",[30],{"name":26,"role":31,"phone":32,"phoneExt":10,"email":33},"CONTACT","01126594679","sheffaligulati@gmail.com",{"type":28,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Sheffali Gulati","Professor","100586313","impact-of-air-quality-on-the-effectiveness-of-standard-of-care-therapy-in-children-with-autism-spectrum-disorder-a-prospective-longitudinal-study-100586313",false,"NCT06913751","Impact of Air Quality on the Effectiveness of Standard of Care Therapy in Children With Autism Spectrum Disorder: A Prospective Longitudinal Study","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\n\n\\-\n\nExclusion Criteria:\n\n1. Other known secondary causes of ASD like Fragile-X Syndrome, Down Syndrome, Tuberous sclerosis, etc.\n2. ASD with known metabolic disorders\n3. ASD with drug refractory epilepsy\n\n   \\-","ALL","3 Years","12 Years",{"count":47,"type":48},66,"ESTIMATED","OBSERVATIONAL","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\n2. 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\u002Fstandard of care in children with autism, as well as on their sleep habits and behaviour.\n\nOur study aims to add to this growing body of evidence of the effect of air pollution on ASD in children.",[52],"Autism Spectrum Disorder",[54,55],"autism spectrum disorder","Air pollution","NOT_YET_RECRUITING","2025-03-31",{"date":59,"type":60},"2025-04-06","ACTUAL",{"date":62,"type":48},"2025-04",{"date":64,"type":48},"2026-09",{"name":5,"class":6}]