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NCT07738003Recruiting

Perinatal Autism Genetics and Epigenetics Study

Perinatal Experience and Epigenetic Change in Autism: Discovering Modifiable Pathways for Intervention

Source: ClinicalTrials.gov · Last updated 3 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
7200 (estimated)
First submitted
27 Jul 2026
Start date
12 May 2026
Primary completion date
31 May 2029
Lead sponsor
University of Iowa
Diseases
Autism
NCT number
NCT07738003

What you commit to

  • Study type: Observational
  • Planned participants: 7200
  • From 12 May 2026 to the primary completion date, 31 May 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of severe mental illness in the past year, resulting in inpatient admission
  • 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

Age

  • \<35 weeks gestational age at birth
  • ASD Group at age 18 to 27 months
    • \- None
  • Developmental Delay (DD) Group at age 18 to 27 months
  • Typically Developing (TD) Group at age 18 to 27 months

Other

  • Criteria for Pregnant Women:
  • Non-English speaking mother
  • All children
  • Screen positive for ASD (M-CHAT \>= 4 AND POSI \>= 3)
  • First-degree relative who has been diagnosed with ASD
  • 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

Who the study is looking for

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

Age in the registry: 0 years to 50 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Center fro Disabilities and Development
Coordinator of this site? Confirm its status
Iowa CityUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.