[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548643":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":33,"locations":43,"responsibleParty":97,"collaborators":99,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":116,"sex":117,"minAge":38,"maxAge":118,"enrollmentInfo":119,"targetDuration":38,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":46,"whyStopped":38,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"IDeA States Pediatric Clinical Trials Network","NETWORK",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Personalized coaching sessions","EXPERIMENTAL","A novel program to train birthing parents in contingent responding with the goal of improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. 1 personalized coaching session per month for 12 months.",[13],"Behavioral: Play and Learn Strategies (PALS) Program",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BEHAVIORAL","Play and Learn Strategies (PALS) Program","Monthly modules and personalized coaching sessions designed to strengthen maternal responsiveness and sensitivity which, in turn, improves infant social-emotional behavior and development outcomes.",[9],[21],"ePALS",[23,27,30],{"name":24,"affiliation":25,"role":26},"Jessie Maxwell, MD","University of New Mexico","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":29,"role":26},"Leigh-Anne Cioffredi, MD","University of Vermont",{"name":31,"affiliation":32,"role":26},"Maria Barber, DO","Avera Research Institute",[34,40],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Song Ounpraseuth, PhD","CONTACT","(501) 686-5647",null,"STOunpraseuth@uams.edu",{"name":41,"role":36,"phone":37,"phoneExt":38,"email":42},"Matthew Henry, MSc","mhenry3@uams.edu",[44,64,81],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"University of New Mexico Health Sciences Center","RECRUITING","Albuquerque","New Mexico","87131","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-106.65114,35.08449,{"lat":56,"lon":55},[59,61],{"name":24,"role":36,"phone":38,"phoneExt":38,"email":60},"JRMaxwell@salud.unm.edu",{"name":62,"role":36,"phone":38,"phoneExt":38,"email":63},"Sandra Beauman, MSN","SBeauman@salud.unm.edu",{"facility":32,"status":46,"city":65,"state":66,"zip":67,"country":50,"countryCode":51,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Sioux Falls","South Dakota","57108",{"type":53,"coordinates":69},[70,71],-96.72796,43.54369,{"lat":71,"lon":70},[74,76,80],{"name":31,"role":36,"phone":38,"phoneExt":38,"email":75},"Maria.Barber@avera.org",{"name":77,"role":36,"phone":78,"phoneExt":38,"email":79},"Meggie McCoy, BS","(605) 504-3154","Meggie.McCoy@avera.org",{"name":31,"role":26,"phone":38,"phoneExt":38,"email":38},{"facility":82,"status":46,"city":83,"state":84,"zip":85,"country":50,"countryCode":51,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"University of Vermont Medical Center","Burlington","Vermont","05401",{"type":53,"coordinates":87},[88,89],-73.21207,44.47588,{"lat":89,"lon":88},[92,94],{"name":28,"role":36,"phone":38,"phoneExt":38,"email":93},"Leigh-Anne.Cioffredi@uvmhealth.org",{"name":95,"role":36,"phone":38,"phoneExt":38,"email":96},"Laurie Chassereau, RN","laurie.chassereau@med.uvm.edu",{"type":98,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[100,102,103,105],{"name":25,"class":101},"OTHER",{"name":29,"class":101},{"name":32,"class":104},"UNKNOWN",{"name":106,"class":107},"National Institutes of Health (NIH)","NIH","100548643","improving-neurodevelopmental-outcomes-after-prenatal-cannabinoid-in-utero-exposure-100548643",false,"NCT06423664","Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure","Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (INTACT)","INTACT","Inclusion Criteria:\n\nBirthing Parent\n\n* Age of majority, as defined by the state of residency\n* Cannabinoid use during pregnancy confirmed with self-report\n* Have the ability to speak, read, and understand English\n* Birthing parent who delivered at one of the hospitals where study team members have clinical privileges to access medical records\n* Has parental custody of the infant\n* Singleton pregnancy with live birth\n* Has an electronic device capable of watching videos and able to stream\u002Fdownload videos for viewing and permitting video conferencing\n* Has study access to the internet\n\nInfant\n\n* Term infants at birth (\\>37 weeks' gestation)\n* Biological child of the birthing parent\n\nExclusion Criteria:\n\nBirthing Parent\n\n* Other illicit drug use, excluding cannabinoids, during pregnancy (such as heroin or cocaine) per self-reported or toxicology results\n* Opiate use (prescribed or unprescribed) per self-report or toxicology results during this pregnancy\n* Prolonged hospitalization following delivery longer than 7 days\n\nInfant\n\n* Has major birth defect(s) including physical anomalies including limb malformations\u002Fabsence of limbs or chromosomal abnormalities\n* Diagnosed with neonatal encephalopathy, metabolic disorder, stroke, intracranial hemorrhage, or meningitis during birth hospitalization\n* Received any major surgical intervention during the birth hospitalization or required a prolonged birth hospitalization (prolonged hospitalization being any hospitalization longer than 7 days)",true,"ALL","7 Days",{"count":120,"type":121},20,"ESTIMATED","INTERVENTIONAL",[124],"NA","The INTACT trial is a multisite pilot feasibility study aimed at testing the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. The trial will enroll 20 birthing parent\u002Finfant dyads across three sites and will evaluate feasibility endpoints rather than clinical outcomes. The study duration is 22 months, including study start-up, enrollment and intervention, and data analysis and manuscript preparation.",[127],"Developmental Delay",[129,130,131,132,133,134],"Behavioral health intervention","Prenatal substance exposure","Neurodevelopmental outcomes","Pediatric intervention","Developmental disorders","Pediatric health","2025-06-23",{"date":137,"type":138},"2025-06-24","ACTUAL",{"date":140,"type":138},"2025-02-06",{"date":142,"type":121},"2026-08-31",{"name":5,"class":6},3]