Perinatal Autism Genetics and Epigenetics study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows pregnant participants from the third trimester to 30 months after birth, collecting pregnancy data, at-home activities, online interviews, and cheek-cell genetic samples from the baby. Researchers will look for epigenetic changes in genes related to social communication, such as the oxytocin receptor gene, and see how these relate to autism and developmental outcomes. The study recruits about 7,200 pregnant women who use BabySteps to track data and screen offspring for ASD or developmental delays, with full diagnostic assessments offered as needed. Data will include perinatal stress, early social experience, and polygenic risk scores to identify possible modifiable pathways for intervention. Findings aim to illuminate how prenatal factors and early experiences influence autism risk and development.

Why it matters

Who can join: the full rules

Inclusion Criteria:

A. Criteria for Pregnant Women:

1. Pregnant women in their 1st or 2nd trimester of a singleton pregnancy.
2. Age 18 to 50 years
3. Currently use a smart phone

B. ASD Group at age 18 to 27 months

1. M-CHAT score \>= 4 or POSI score \>= 3
2. Child has subsequently clinically confirmed diagnosis of ASD, based on ADOS/TAP testing and/or other clinical evaluation

C. Developmental Delay (DD) Group at age 18 to 27-months

1. Developmental screening score on SWYC in the "at risk" range.
2. Child has subsequently clinically confirmed developmental delay on clinical evaluation and/or self-report measure

D. Typically Developing (TD) Group at age 18 to 27 months - None

Exclusion Criteria:

A. Criteria for Pregnant Women:

1. Non-English speaking mother
2. History of severe mental illness in the past year, resulting in inpatient admission

B. All children

1. \<35 weeks gestational age at birth
2. History of serious neonatal complications requiring NICU admission for one week or more
3. Known genetic or syndromic condition (e.g. Down Syndrome, etc.) that impacts learning and brain development
4. Hearing impairment

C. ASD Group at age 18 to 27 months

\- None

D. Developmental Delay (DD) Group at age 18 to 27 months

1. Screen positive for ASD (M-CHAT \>= 4 AND POSI \>= 3)
2. First-degree relative who has been diagnosed with ASD

E. Typically Developing (TD) Group at age 18 to 27 months

1. Screen positive for ASD (M-CHAT \>= 4 AND POSI \>= 3)
2. Developmental screening/assessment score in the "at risk" range.
3. First-degree relative who has been diagnosed with ASD

Where it's running

• Center fro Disabilities and Development
  Iowa City, Iowa, United States Recruiting

Study contacts

• Principal investigator: Lane Strathearn, MBBS FRACP PhD — University of Iowa
• Study coordinator: John Pienta, MD
• Email: babysteps@uiowa.edu
• Phone: 319-356-7140

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.