Maternal Biomarkers and Environmental Contributors to Autism Spectrum Disorders in Children of First-time Mothers

This study will recruit nuMoM2b participants to complete autism screening surveys and will identify 200 children with autism and 400 controls for the study. It will then use existing biospecimens to measure pesticides in maternal urine and metabolomic urine and cord blood predictors of autism risk. All data will then be used to build a predictive model for autism risk at the child's birth.

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Sex eligibility

All sexes

Study type

Observational

About this study

NuMoM2b participans will be contacted as part of ongoing contacts and will be consented for their offspring to participate. The children will also undergo an Assent process. Screening for autism will occur using standard validated tools and anyone who screens positive will have remote diagnostic testing with trained study staff. The study aims to identify a cohort of 200 children with autism and will then randomly select a group of 400 children typically developing. Predictive models for autism will be constructed using pregnancy and birth data as well as biomarkers from maternal urine and cord blood. We will include metabolomic biomarkers as well as environmental exposures to assess if they improve the predictive model.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

child of nuMoM2b study participant

Exclusion criteria

no biological samples collected during pregnancy

Treatment and study plan

None-placebo

Other

No interventions performed

Primary outcomes

Diagnosis of autims

Time frame: The children are age 11-14 currently. The outcome will be measured during contact with the children in the first 18 months of the project.

Autism diagnoses will be made using the Autism Diagnostic Inventory on all children who screen positive. Alternatively, if already diagnosed clinically, we will request the diagnostic tool used previously for the child.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jul 17, 2025
Registry last updated: Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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