Perinatal Autism Genetics and Epigenetics Study

ConditionsAutism Disorders and Maternal Stress Development Delay Prenatal Stress Social Behavior

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age0-50

SponsorUniversity of Iowa

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant women in their 1st or 2nd trimester of a singleton pregnancy.

Age 18 to 50 years

Currently use a smart phone

M-CHAT score >= 4 or POSI score >= 3

Disqualifiers

Non-English speaking mother

History of severe mental illness in the past year, resulting in inpatient admission

<35 weeks gestational age at birth

History of serious neonatal complications requiring NICU admission for one week or more

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Change in child's DNA methylation
Genetic
DNA methylation in pre-specified regions will be compared between birth, 24 and 30 months.
Perinatal stress
Behavioral
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
Behavioral
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
Genetic
Genomic data will be used to calculate polygenic risk scores for social communication and repetitive behavior.

Treatment groups

7,200 Participants

are divided into 4 treatment groups

Group A: Pregnant women/mothers0 interventions

Group B: Children with autism spectrum disorder (ASD)4 interventions

Group C: Group with developmental delay (but no ASD)4 interventions

Group D: Typically developing (TD) group4 interventions

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Iowa

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov

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