Autism Disorders and Maternal StressPAGESNCT07738003
Perinatal Autism Genetics and Epigenetics Study
An observational study of Autism Disorders and Maternal Stress and Development Delay, run by University of Iowa at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Disorders and Maternal Stress, Development Delay, Prenatal Stress
- What is being tested?
- Change in child's DNA methylation, Perinatal stress and Early social experience
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 7,200 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2026to May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pregnant women (prior to 3rd trimester) from throughout the United States.
Who may be able to join
- 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
- ASD Group at age 18 to 27 months
- M-CHAT score >= 4 or POSI score >= 3
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- Child has subsequently clinically confirmed diagnosis of ASD, based on ADOS/TAP testing and/or other clinical evaluation
- 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
- Typically Developing (TD) Group at age 18 to 27 months - None
Who cannot join
- Criteria for Pregnant Women:
- Non-English speaking mother
- History of severe mental illness in the past year, resulting in inpatient admission
- All children
- <35 weeks gestational age at birth
- History of serious neonatal complications requiring NICU admission for one week or more
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- Known genetic or syndromic condition (e.g. Down Syndrome, etc.) that impacts learning and brain development
- Hearing impairment
- ASD Group at age 18 to 27 months
- None
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center fro Disabilities and Development
Iowa City, Iowa, 52246
John Pienta, MD, 319-356-7140, john-pienta@uiowa.edu
Lane Strathearn, MBBS FRACP PhD
About this study
Official title: Perinatal Experience and Epigenetic Change in Autism: Discovering Modifiable Pathways for Intervention
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.
Read the detailed description
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.
- Being tested
- Change in child's DNA methylation, Perinatal stress, Early social experience, Polygenic risk scores for social communication and repetitive behavior
- Keywords
- autism, epigenetics, prenatal stress, social experience, developmental delay
- Medical subject headings
- Learning Disabilities, Social Behavior, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in child's DNA methylationGenetic
DNA methylation in pre-specified regions will be compared between birth, 24 and 30 months.
Perinatal stressBehavioural
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 experienceBehavioural
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 behaviorGenetic
Genomic data will be used to calculate polygenic risk scores for social communication and repetitive behavior.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women/mothers | Recruited prior to the 3rd trimester of pregnancy | |
| Children with autism spectrum disorder (ASD) | Children of pregnant women/mothers at 18-24 months of age Receives: Genetic: Change in child's DNA methylation; Behavioral: Perinatal stress; Behavioral: Early social experience; Genetic: Polygenic risk scores for social communication and repetitive behavior | |
| Group with developmental delay (but no ASD) | Children of pregnant women/mothers at 18-24 months of age Receives: Genetic: Change in child's DNA methylation; Behavioral: Perinatal stress; Behavioral: Early social experience; Genetic: Polygenic risk scores for social communication and repetitive behavior | |
| Typically developing (TD) group | Children of pregnant women/mothers at 18-24 months of age Receives: Genetic: Change in child's DNA methylation; Behavioral: Perinatal stress; Behavioral: Early social experience; Genetic: Polygenic risk scores for social communication and repetitive behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 months
Secondary outcomes (1)
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)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start12 May 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Disorders and Maternal StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Lane Strathearn, MBBS PhD, University of Iowa
- Investigators
- Lane Strathearn, MBBS FRACP PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738003
- Sponsor's protocol ID
- 202210423
- Other IDs
- R01HD102619
- Acronym
- PAGES
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal Experience and Epigenetic Change in Autism: Discovering Modifiable Pathways for Intervention
- ClinicalTrials.gov ID
- NCT07738003
- Acronym / sponsor ID
- PAGES / 202210423
- Keywords
- autism, epigenetics, prenatal stress, social experience, developmental delay
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,200 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 12 May 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregnant women/mothers | – | –Recruited prior to the 3rd trimester of pregnancy |
| Children with autism spectrum disorder (ASD) | – | Genetic: Change in child's DNA methylation, Behavioral: Perinatal stress, Behavioral: Early social experience, Genetic: Polygenic risk scores for social communication and repetitive behaviorChildren of pregnant women/mothers at 18-24 months of age |
| Group with developmental delay (but no ASD) | – | Genetic: Change in child's DNA methylation, Behavioral: Perinatal stress, Behavioral: Early social experience, Genetic: Polygenic risk scores for social communication and repetitive behaviorChildren of pregnant women/mothers at 18-24 months of age |
| Typically developing (TD) group | – | Genetic: Change in child's DNA methylation, Behavioral: Perinatal stress, Behavioral: Early social experience, Genetic: Polygenic risk scores for social communication and repetitive behaviorChildren of pregnant women/mothers at 18-24 months of age |
Who may qualify
- Ages
- 0 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pregnant women (prior to 3rd trimester) from throughout the United States.
Key inclusion criteria (11 listed)
- 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
- ASD Group at age 18 to 27 months
Key exclusion criteria (17 listed)
- Criteria for Pregnant Women:
- Non-English speaking mother
- History of severe mental illness in the past year, resulting in inpatient admission
- All children
- <35 weeks gestational age at birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change in child's DNA methylationDNA methylation in pre-specified regions will be compared between birth, 24 and 30 months. | Genetic | Children with autism spectrum disorder (ASD), Group with developmental delay (but no ASD), Typically developing (TD) group |
| Perinatal stressPerinatal 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. | Behavioural | Children with autism spectrum disorder (ASD), Group with developmental delay (but no ASD), Typically developing (TD) group |
| Early social experienceThe 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. | Behavioural | Children with autism spectrum disorder (ASD), Group with developmental delay (but no ASD), Typically developing (TD) group |
| Polygenic risk scores for social communication and repetitive behaviorGenomic data will be used to calculate polygenic risk scores for social communication and repetitive behavior. | Genetic | Children with autism spectrum disorder (ASD), Group with developmental delay (but no ASD), Typically developing (TD) group |
Primary outcome
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.
1 secondary outcome
Categorical diagnosis, using the TELE-ASD-PEDS, Adaptive Behavior Assessment System (ABAS-3), and the Survey of Well-being of Young Children (SWYC).
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Study enrollment and screening pageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lane Strathearn, MBBS FRACP PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Disorders and Maternal Stress and Development Delay, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Pienta, MD (319-356-7140, babysteps@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.