An observational study in Autism Disorders and Maternal Stress, Development Delay and Prenatal Stress, sponsored by University of Iowa. Recruiting at 1 site in United States. Open to participants aged 0 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by University of Iowa · Observational
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.
Autism spectrum disorder (ASD) is one of the most common neurodevelopmental disabilities, adversely affecting an increasing number of families worldwide. Although its etiology is strongly linked to genetic factors, perinatal experience, including prenatal stress and post-natal social experience, may also contribute to deficits in social communication in ASD, potentially via epigenetic mechanisms. For example, the oxytocin receptor gene (OXTR) is epigenetically altered by early social experience, plays a crucial role in mammalian social and cognitive development, and is associated with both genetic and epigenetic risk for ASD. However, the relationship between perinatal experience and epigenetic change in ASD is unclear. Our central hypothesis is that prenatal stress and early social experience predicts epigenetic changes in specific genes, which are associated with social communication deficits in ASD. To achieve our overall goal of discovering modifiable pathways for intervention in children at risk for ASD, we will recruit over 7,200 pregnant women to use a smartphone tool called BabySteps, to collect prospective data from the 3rd trimester of pregnancy until 30 months post-delivery. Between ages 18 to 27 months, BabySteps will be used to screen for symptoms of ASD or developmental delay (DD) in the offspring, which will trigger a full diagnostic assessment online or in person at the Center for Disabilities and Development. Children with a range of social communication deficits (including those diagnosed with ASD or non-ASD DD [n=200]) will be compared with typically developing children (TD; n=200) who are matched on race, sex, and socioeconomic status. We will examine 1) differences in DNA methylation (DNAm), and change over time, in specific ASD-associated loci and OXTR loci, and 2) differences in biologic age acceleration using epigenetic clock algorithms, as a function of age, perinatal experience, and social communication outcomes. We will compare DNAm from buccal swabs to samples collected around the time of diagnosis. We will calculate polygenic risk scores for social communication, repetitive behavior, and ASD, and assess the relative polygenic and epigenetic risk. The relationship between perinatal experience, DNAm, and social communication outcomes will be evaluated using 4 complementary measures: 1) ecological momentary assessments (EMAs) of prenatal stress and parental anxiety and depression, collected using BabySteps; 2) app-recorded free play between parent and child analyzed for dyadic synchrony and interactive behavior; 3) standardized assessments of child social communication skills; and 4) a Language ENvironment Analysis (LENA), using a LENA audio-recording device worn by the child at home and in daycare. We expect to identify epigenetic biomarkers that link prenatal stress and early social experience with social communication outcomes in ASD. A better understanding of how polygenic risk and perinatal experience-via epigenetic mechanisms-contribute to the ASD phenotype will help overcome a critical barrier to progress in the field, by identifying modifiable pathways for intervention.
270 studies on the registry are indexed under Learning Disabilities; 62 are open to participants now.
This study's planned enrollment of 7,200 is above the median of 150 across 82 observational studies indexed under Learning Disabilities.
Browse Learning Disabilities studies →University of Iowa is the lead sponsor of 279 studies on the registry; 33 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 40 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pregnant women (prior to 3rd trimester) from throughout the United States.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A. Criteria for Pregnant Women:
B. ASD Group at age 18 to 27 months
C. Developmental Delay (DD) Group at age 18 to 27-months
D. Typically Developing (TD) Group at age 18 to 27 months - None
Exclusion Criteria:
A. Criteria for Pregnant Women:
B. All children
C. ASD Group at age 18 to 27 months
- None
D. Developmental Delay (DD) Group at age 18 to 27 months
E. Typically Developing (TD) Group at age 18 to 27 months
Recruited prior to the 3rd trimester of pregnancy
Children of pregnant women/mothers at 18-24 months of age
Genetic: Change in child's DNA methylation · Behavioral: Perinatal stress · Behavioral: Early social experience · Genetic: Polygenic risk scores for social communication and repetitive behavior
Children of pregnant women/mothers at 18-24 months of age
Genetic: Change in child's DNA methylation · Behavioral: Perinatal stress · Behavioral: Early social experience · Genetic: Polygenic risk scores for social communication and repetitive behavior
Children of pregnant women/mothers at 18-24 months of age
Genetic: Change in child's DNA methylation · Behavioral: Perinatal stress · Behavioral: Early social experience · Genetic: Polygenic risk scores for social communication and repetitive behavior
DNA methylation in pre-specified regions will be compared between birth, 24 and 30 months.
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.
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.
Genomic data will be used to calculate polygenic risk scores for social communication and repetitive behavior.
Social communication, as measured by the Social Responsiveness Scale (SRS-2) and the Autism Spectrum Rating Scale (ASRS)
A latent-variable approach will be used to obtain a continuous measure of social communication ability.
Time frame: 30 months
Categorical diagnosis, using the TELE-ASD-PEDS, Adaptive Behavior Assessment System (ABAS-3), and the Survey of Well-being of Young Children (SWYC).
Children will be categorized into one of 3 groups: Autism spectrum disorder (ASD), Non-ASD developmental delay (DD) or Typical development (TD)
Time frame: 24 months
Plan to share: Yes — With patient consent, data to be preserved and shared will include: cleaned, item-level tabular data, including 1) raw genomic and DNA methylation data; 2) behavioral/phenotypic, and clinical data; and 3) video and audio data with derived coding variables. This will allow other researchers to access and analyze other questions related to the collected data. A Data Submission Agreement has been submitted to NIMH Data Archive (NDA) and a Data Expected List has been created. To facilitate the interpretation and reuse of the data, a data dictionary will be generated and deposited into a repository along with all shared datasets.
Supporting information: Study protocol, Informed consent form
Time frame: Beginning up to 1 year after publication with no end date
Access criteria: Access to data for possible reuse will be controlled by the NIMH Data Archive (NDA) and Databrary. Distribution of the data is not permitted. Data and associated item-level metadata will be available for educational and research purposes, subject to participant consent and meeting the repository requirements for access. Access to the data in NDA will be controlled, and the NDA Data Access Committee will decide which requests to grant. The standard NDA data access process allows access for one year and is renewable. Data shared through Databrary will only be viewable and downloadable to authorized users who have been granted secure access by Databrary's administrators. Select data may be made available to the public, but only as determined by the researcher and based on participant permission. Lead PI Dr Lane Strathearn, ORCID: 0000-0001-5870-8843, will be responsible for oversight of the project's data management activities and data sharing.
Data sharing details ↗ · nda.nih.gov
Started May 2026 (actual). Primary completion is estimated for May 2029, 36 months after the start.
Of 34 observational studies under Learning Disabilities, half reached primary completion within 110 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 150. This study's planned 36 months is below that.
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