Perinatal Autism Genetics and Epigenetics Study

NCT07738003 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 7200

Last updated 2026-08-03

No results posted yet for this study

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.

Conditions

  • Autism Disorders and Maternal Stress
  • Development Delay
  • Prenatal Stress
  • Social Behavior

Interventions

GENETIC

Change in child's DNA methylation

DNA methylation in pre-specified regions will be compared between birth, 24 and 30 months.

BEHAVIORAL

Perinatal stress

Perinatal stress will be measured using the Perceived Stress Scale (PSS-14), Edinburgh Postnatal Depression Scale (EPDS), General Anxiety Disorder (GAD-7), Social Provisions Scale (SPS-10), and ecological momentary assessments of stress, anxiety and sadness.

BEHAVIORAL

Early social experience

The child's early social experience will be measured directly using videotaped mother-child interaction coded using the CARE-Index, and indirectly using the Adult Attachment Interview.

GENETIC

Polygenic risk scores for social communication and repetitive behavior

Genomic data will be used to calculate polygenic risk scores for social communication and repetitive behavior.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • University of Iowa

    lead OTHER

Principal Investigators

  • Lane Strathearn, MBBS FRACP PhD · University of Iowa

Eligibility

Min Age
0 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-12
Primary Completion
2029-05-31
Completion
2030-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07738003 on ClinicalTrials.gov