RecruitingNCT07738003

Perinatal Autism Genetics and Epigenetics Study

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

Sponsor

University of Iowa

Enrollment

7,200 participants

Start Date

May 12, 2026

Study Type

OBSERVATIONAL

Conditions

Social Behavior Development Delay Autism Disorders and Maternal Stress Prenatal Stress

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.

Eligibility

Min Age: 0 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with autism disorders and maternal stress, development delay, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 0 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICChange in child's DNA methylation

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

BEHAVIORALPerinatal 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.

BEHAVIORALEarly 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.

GENETICPolygenic risk scores for social communication and repetitive behavior

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