Recruiting

Autism Research

Sponsor:

University of Iowa

Code:

NCT07738003

Conditions

Autism Disorders and Maternal Stress

Development Delay

Prenatal Stress

Social Behavior

Eligibility Criteria

Sex: All

Age: 0 - 50

Healthy Volunteers: Accepted

Interventions

Change in child's DNA methylation

Perinatal stress

Early social experience

Polygenic risk scores for social communication and repetitive behavior

Study Details

Brief 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.

Conditions

Autism Disorders and Maternal Stress

Development Delay

Prenatal Stress

Social Behavior

Study ID

NCT07738003

Start date

May 12, 2026

Status verified date

Jul, 2026

Completion date

May, 2030

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 50

Healthy Volunteers: Accepted

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. <35 weeks gestational age at birth
2. History of serious neonatal complications requiring NICU admission for one week or more
3. Known genetic or syndromic condition (e.g. Down Syndrome, etc.) that impacts learning and brain development
4. Hearing impairment

C. ASD Group at age 18 to 27 months

\- None

D. Developmental Delay (DD) Group at age 18 to 27 months

1. Screen positive for ASD (M-CHAT >= 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

Study Design

Enrollment

7200 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Group with developmental delay (but no ASD)

Children of pregnant women/mothers at 18-24 months of age

Typically developing (TD) group

Children of pregnant women/mothers at 18-24 months of age

Interventions

Change in child's DNA methylation

DNA methylation in pre-specified regions will be compared between birth, 24 and 30 months.

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.

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.

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 measure

  • Social communication, as measured by the Social Responsiveness Scale (SRS-2) and the Autism Spectrum Rating Scale (ASRS) [ Time Frame: 30 months ]

Central Contacts and Locations

Central contacts

Lane Strathearn, MBBS FRACP PhD

319-356-9464lstrathearn@uiowa.edu

Locations

Center fro Disabilities and Development

Recruiting

Iowa City, Iowa, United States, 52246

Contacts

Principal Investigator:

Lane Strathearn, MBBS FRACP PhD

More Information

Sponsor

University of Iowa

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • autism
  • epigenetics
  • prenatal stress
  • social experience
  • developmental delay

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Iowa on 2026-08-03.