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NCT07738003
Perinatal Autism Genetics and Epigenetics Study
Conditions: Autism Disorders and Maternal Stress, Development Delay, Prenatal Stress, Social Behavior
Sex: All
Ages: 0 Years – 50 Years
Healthy volunteers: Yes
Enrollment: 7200
Sponsor: University of Iowa
Location: Center fro Disabilities and Development Iowa City Iowa
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 Criteria
Inclusion Criteria:
A. Criteria for Pregnant Women:
1. Pregnant women in their 1st or 2nd trimester of a singleton pregnancy.
2. Age 18 to 50 years
3. Currently use a smart phone
B. ASD Group at age 18 to 27 months
1. M-CHAT score \>= 4 or POSI score \>= 3
2. 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
1. Developmental screening score on SWYC in the "at risk" range.
2. 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
Exclusion Criteria:
A. Criteria for Pregnant Women:
1. Non-English speaking mother
2. History of severe mental illness in the past year, resulting in inpatient admission
B. All children
1. \= 4 AND POSI \>= 3)
2. First-degree relative who has been diagnosed with ASD
E. Typically Developing (TD) Group at age 18 to 27 months
1. Screen positive for ASD (M-CHAT \>= 4 AND POSI \>= 3)
2. Developmental screening/assessment score in the "at risk" range.
3. First-degree relative who has been diagnosed with ASD
Source: ClinicalTrials.gov (NCT07738003). StuddyBuddy aggregates publicly available trial information.