Perinatal Autism Genetics and Epigenetics Study

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Iowa
Study ID
NCT07738003
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
0 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Change in child's DNA methylation — GENETIC
    DNA methylation in pre-specified regions will be compared between birth, 24 and 30 months.
  • Perinatal stress — BEHAVIORAL
    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.
  • Early social experience — BEHAVIORAL
    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.
  • Polygenic risk scores for social communication and repetitive behavior — GENETIC
    Genomic data will be used to calculate polygenic risk scores for social communication and repetitive behavior.

Study Details

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.

Key Dates

First listed
Jul 30, 2026
Start date
May 12, 2026
Status verified
Jul 2026
Primary completion
May 31, 2029
Completion
May 31, 2030

Study Design

Enrollment
7,200 participants (estimated)

Arms

  • Arm: Pregnant women/mothers
    Recruited prior to the 3rd trimester of pregnancy
  • Arm: Children with autism spectrum disorder (ASD)
    Children of pregnant women/mothers at 18-24 months of age
  • Arm: Group with developmental delay (but no ASD)
    Children of pregnant women/mothers at 18-24 months of age
  • Arm: Typically developing (TD) group
    Children of pregnant women/mothers at 18-24 months of age

Primary Outcome Measure

Social communication, as measured by the Social Responsiveness Scale (SRS-2) and the Autism Spectrum Rating Scale (ASRS) [ Time Frame: 30 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Center fro Disabilities and DevelopmentIowa CityIowa52246
John Pienta, MD
[email protected]
319-356-7140
Lane Strathearn, MBBS FRACP PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Center fro Disabilities and Development· Iowa City, IA

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