Perinatal Autism Genetics and Epigenetics Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-50
SponsorUniversity of Iowa
About this trial
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
Qualifiers
Pregnant women in their 1st or 2nd trimester of a singleton pregnancy.
Age 18 to 50 years
Currently use a smart phone
M-CHAT score >= 4 or POSI score >= 3
Disqualifiers
Non-English speaking mother
History of severe mental illness in the past year, resulting in inpatient admission
<35 weeks gestational age at birth
History of serious neonatal complications requiring NICU admission for one week or more
Trial design
Treatments tested in this trial
- Change in child's DNA methylation
- Perinatal stress
- Early social experience
- Polygenic risk scores for social communication and repetitive behavior
Treatment groups
7,200 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of Iowa
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov