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Perinatal Autism Genetics and Epigenetics Study
Perinatal Experience and Epigenetic Change in Autism: Discovering Modifiable Pathways for Intervention
Who can join
Ages 0 to 50 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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
About the study
The University of Iowa's Center for Disabilities and Development is researching how pregnancy, early childhood experiences, and genetic factors influence child development, with a focus on autism spectrum disorder (ASD). Pregnant women are invited to participate in a study that tracks their pregnancy and child's early development, through simple, at-home activities using a cell phone. Participants complete short questionnaires, join an online interview, and videotape their baby's play after birth. They are also sent a kit to swab their baby's mouth to collect cheek cells for genetic testing. The study will explore whether stress and early social experience lead to genetic changes associated with autism or other developmental conditions.
What is being tested
- Change in child's DNA methylation (genetic)
- Perinatal stress (behavioral)
- Early social experience (behavioral)
- Polygenic risk scores for social communication and repetitive behavior (genetic)
Sponsor: University of Iowa · Participants: 7,200 · Started: May 12, 2026
Contact the study team
- John Pienta, MD · Phone: 319-356-7140
- Lane Strathearn, MBBS FRACP PhD · Phone: 319-356-9464
Official record on ClinicalTrials.gov — NCT07738003
Locations in the U.S.
| Iowa | Center fro Disabilities and Development, Iowa City |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.