NCT07738003 · University of Iowa
Perinatal Autism Genetics and Epigenetics Study
(PAGES)
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Social communication, as measured by the Social Responsiveness Scale (SRS-2) and the Autism Spectrum Rating Scale (ASRS)
Time frame: 30 months
A latent-variable approach will be used to obtain a continuous measure of social communication ability.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- A. Criteria for Pregnant Women:
- Pregnant women in their 1st or 2nd trimester of a singleton pregnancy.
- Age 18 to 50 years
- Currently use a smart phone B. ASD Group at age 18 to 27 months
- M-CHAT score \>= 4 or POSI score \>= 3
- 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
- Developmental screening score on SWYC in the "at risk" range.
- 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:
- Non-English speaking mother
- History of severe mental illness in the past year, resulting in inpatient admission B. All children
- \<35 weeks gestational age at birth
- History of serious neonatal complications requiring NICU admission for one week or more
- Known genetic or syndromic condition (e.g. Down Syndrome, etc.) that impacts learning and brain development
- Hearing impairment C. ASD Group at age 18 to 27 months \- None D. Developmental Delay (DD) Group at age 18 to 27 months
- Screen positive for ASD (M-CHAT \>= 4 AND POSI \>= 3)
- First-degree relative who has been diagnosed with ASD E. Typically Developing (TD) Group at age 18 to 27 months
- Screen positive for ASD (M-CHAT \>= 4 AND POSI \>= 3)
- Developmental screening/assessment score in the "at risk" range.
- First-degree relative who has been diagnosed with ASD
Where
- Iowa City, Iowa
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 3, 2026 · Source of record for eligibility and locations