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Could a mother's stress leave a mark on her baby's genes? a large study investigates.

NCT ID NCT07738003

Knowledge-focused Sponsor: University of Iowa Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This study follows pregnant women and their children from the first trimester through toddlerhood to explore how stress, early social experiences, and genetics interact. Using simple at-home activities like questionnaires, video recordings, and cheek swabs, researchers will look for genetic changes that might be linked to autism or developmental delays. The goal is to uncover pathways that could one day be targeted for early intervention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If this study identifies modifiable pathways, it could point toward ways to reduce autism risk or improve early support.
What could go wrong
This is an observational study, not a treatment trial. It may find associations but cannot prove cause and effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 7,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pregnant women (prior to 3rd trimester) from throughout the United States.

Ages

0 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

autism autism spectrum disorder learning disability Social Behavior

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism disorders and maternal stress Development delay Prenatal stress Social behavior

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Center fro Disabilities and Development

    RECRUITING

    Iowa City, Iowa, 52246, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.