[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649681":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":45,"centralContacts":49,"locations":58,"responsibleParty":77,"collaborators":80,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":10,"studyType":99,"phases":10,"briefSummary":100,"conditions":101,"keywords":106,"overallStatus":61,"whyStopped":10,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University of Iowa","OTHER",[8,12,20,23],{"label":9,"type":10,"description":11,"interventionNames":10},"Pregnant women\u002Fmothers",null,"Recruited prior to the 3rd trimester of pregnancy",{"label":13,"type":10,"description":14,"interventionNames":15},"Children with autism spectrum disorder (ASD)","Children of pregnant women\u002Fmothers at 18-24 months of age",[16,17,18,19],"Genetic: Change in child's DNA methylation","Behavioral: Perinatal stress","Behavioral: Early social experience","Genetic: Polygenic risk scores for social communication and repetitive behavior",{"label":21,"type":10,"description":14,"interventionNames":22},"Group with developmental delay (but no ASD)",[16,17,18,19],{"label":24,"type":10,"description":14,"interventionNames":25},"Typically developing (TD) group",[16,17,18,19],[27,32,37,41],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"GENETIC","Change in child's DNA methylation","DNA methylation in pre-specified regions will be compared between birth, 24 and 30 months.",[13,21,24],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"BEHAVIORAL","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.",[13,21,24],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"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.",[13,21,24],{"type":28,"name":42,"description":43,"armGroupLabels":44,"otherNames":10},"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.",[13,21,24],[46],{"name":47,"affiliation":5,"role":48},"Lane Strathearn, MBBS FRACP PhD","PRINCIPAL_INVESTIGATOR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":10,"email":54},"John Pienta, MD","CONTACT","319-356-7140","babysteps@uiowa.edu",{"name":47,"role":52,"phone":56,"phoneExt":10,"email":57},"319-356-9464","lstrathearn@uiowa.edu",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Center fro Disabilities and Development","RECRUITING","Iowa City","Iowa","52246","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-91.53017,41.66113,{"lat":71,"lon":70},[74,76],{"name":51,"role":52,"phone":53,"phoneExt":10,"email":75},"john-pienta@uiowa.edu",{"name":47,"role":48,"phone":10,"phoneExt":10,"email":10},{"type":48,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Lane Strathearn, MBBS PhD","Principal Investigator",[81],{"name":82,"class":83},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100649681","perinatal-autism-genetics-and-epigenetics-study-100649681",false,"NCT07738003","Perinatal Autism Genetics and Epigenetics Study","Perinatal Experience and Epigenetic Change in Autism: Discovering Modifiable Pathways for Intervention","PAGES","Inclusion Criteria:\n\nA. Criteria for Pregnant Women:\n\n1. Pregnant women in their 1st or 2nd trimester of a singleton pregnancy.\n2. Age 18 to 50 years\n3. Currently use a smart phone\n\nB. ASD Group at age 18 to 27 months\n\n1. M-CHAT score \\>= 4 or POSI score \\>= 3\n2. Child has subsequently clinically confirmed diagnosis of ASD, based on ADOS\u002FTAP testing and\u002For other clinical evaluation\n\nC. Developmental Delay (DD) Group at age 18 to 27-months\n\n1. Developmental screening score on SWYC in the \"at risk\" range.\n2. Child has subsequently clinically confirmed developmental delay on clinical evaluation and\u002For self-report measure\n\nD. Typically Developing (TD) Group at age 18 to 27 months - None\n\nExclusion Criteria:\n\nA. Criteria for Pregnant Women:\n\n1. Non-English speaking mother\n2. History of severe mental illness in the past year, resulting in inpatient admission\n\nB. All children\n\n1. \\\u003C35 weeks gestational age at birth\n2. History of serious neonatal complications requiring NICU admission for one week or more\n3. Known genetic or syndromic condition (e.g. Down Syndrome, etc.) that impacts learning and brain development\n4. Hearing impairment\n\nC. ASD Group at age 18 to 27 months\n\n\\- None\n\nD. Developmental Delay (DD) Group at age 18 to 27 months\n\n1. Screen positive for ASD (M-CHAT \\>= 4 AND POSI \\>= 3)\n2. First-degree relative who has been diagnosed with ASD\n\nE. Typically Developing (TD) Group at age 18 to 27 months\n\n1. Screen positive for ASD (M-CHAT \\>= 4 AND POSI \\>= 3)\n2. Developmental screening\u002Fassessment score in the \"at risk\" range.\n3. First-degree relative who has been diagnosed with ASD",true,"ALL","0 Years","50 Years",{"count":97,"type":98},7200,"ESTIMATED","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.",[102,103,104,105],"Autism Disorders and Maternal Stress","Development Delay","Prenatal Stress","Social Behavior",[107,108,109,110,111],"autism","epigenetics","prenatal stress","social experience","developmental delay","2026-07-31",{"date":114,"type":115},"2026-08-03","ACTUAL",{"date":117,"type":115},"2026-05-12",{"date":119,"type":98},"2030-05",{"name":5,"class":6},1]