Perinatal Autism Genetics and Epigenetics Study
PAGES
Perinatal Experience and Epigenetic Change in Autism: Discovering Modifiable Pathways for Intervention
2 other identifiers
observational
7,200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2026
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 12, 2026
CompletedFirst Submitted
Initial submission to the registry
July 27, 2026
CompletedFirst Posted
Study publicly available on registry
July 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2030
July 30, 2026
July 1, 2026
3 years
July 27, 2026
July 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Social communication
A continuous measure of child's social communication capacity
18-36 months
Secondary Outcomes (1)
Categorical diagnosis
18-36 months
Study Arms (4)
Pregnant women/mothers
Recruited prior to the 3rd trimester of pregnancy
Children with autism spectrum disorder (ASD)
Children of pregnant women/mothers at 18-24 months of age
Group with developmental delay (but no ASD)
Children of pregnant women/mothers at 18-24 months of age
Typically developing (TD) group
Children of pregnant women/mothers at 18-24 months of age
Eligibility Criteria
Pregnant women (prior to 3rd trimester) from throughout the United States.
You may qualify if:
- 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
You may not qualify if:
- 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)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center fro Disabilities and Development
Iowa City, Iowa, 52246, United States
Related Links
Biospecimen
DNA extracted from buccal cells
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lane Strathearn, MBBS FRACP PhD
University of Iowa
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 27, 2026
First Posted
July 30, 2026
Study Start
May 12, 2026
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
May 1, 2030
Last Updated
July 30, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Beginning up to 1 year after publication with no end date
- Access Criteria
- Access to data for possible reuse will be controlled by the NIMH Data Archive (NDA) and Databrary. Distribution of the data is not permitted. Data and associated item-level metadata will be available for educational and research purposes, subject to participant consent and meeting the repository requirements for access. Access to the data in NDA will be controlled, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable. Data shared through Databrary will only be viewable and downloadable to authorized users who have been granted secure access by Databrary's administrators. Select data may be made available to the public, but only as determined by the researcher and based on participant permission. Lead PI Dr Lane Strathearn, ORCID: 0000-0001-5870-8843, will be responsible for oversight of the project's data management activities and data sharing.
With patient consent, data to be preserved and shared will include: cleaned, item-level tabular data, including 1) raw genomic and DNA methylation data; 2) behavioral/phenotypic, and clinical data; and 3) video and audio data with derived coding variables. This will allow other researchers to access and analyze other questions related to the collected data. A Data Submission Agreement has been submitted to NIMH Data Archive (NDA) and a Data Expected List has been created. To facilitate the interpretation and reuse of the data, a data dictionary will be generated and deposited into a repository along with all shared datasets.