Perinatal Autism Genetics and Epigenetics Study
University of Iowa · with Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NCT07738003
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 0 mo–50 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 7200
- US sites recruiting
- 1
- Study start
- May 12, 2026
- Record last updated
- August 3, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Change in child's DNA methylation; Perinatal stress; Early social experience; Polygenic risk scores for social communication and repetitive behavior
Conditions: Autism Disorders and Maternal Stress; Development Delay; Prenatal Stress; Social Behavior
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
A. Criteria for Pregnant Women:
- Pregnant women in their 1st or 2nd trimester of a singleton pregnancy.
- Age 18 to 50 years
- Currently use a smart phone
B. ASD Group at age 18 to 27 months
- M-CHAT score >= 4 or POSI score >= 3
- 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
- Developmental screening score on SWYC in the "at risk" range.
- 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:
- Non-English speaking mother
- History of severe mental illness in the past year, resulting in inpatient admission
B. All children
- \<35 weeks gestational age at birth
- History of serious neonatal complications requiring NICU admission for one week or more
- Known genetic or syndromic condition (e.g. Down Syndrome, etc.) that impacts learning and brain development
- Hearing impairment
C. ASD Group at age 18 to 27 months
- None
D. Developmental Delay (DD) Group at age 18 to 27 months
- Screen positive for ASD (M-CHAT >= 4 AND POSI >= 3)
- First-degree relative who has been diagnosed with ASD
E. Typically Developing (TD) Group at age 18 to 27 months
- Screen positive for ASD (M-CHAT >= 4 AND POSI >= 3)
- Developmental screening/assessment score in the "at risk" range.
- First-degree relative who has been diagnosed with ASD
Recruiting US locations
Center fro Disabilities and Development
Iowa City, IA 52246
Site contact: John Pienta, MD · 319-356-7140 · john-pienta@uiowa.edu
Study contacts (from the official record)
- John Pienta, MD · 319-356-7140 · babysteps@uiowa.edu
- Lane Strathearn, MBBS FRACP PhD · 319-356-9464 · lstrathearn@uiowa.edu
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