[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06423664":3,"trial-entities:NCT06423664":152,"trial-summary:NCT06423664":155},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":43,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":79,"locations":81,"central_contacts":132,"overall_officials":140,"references":146,"see_also_links":151},"NCT06423664","276534","Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure","Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (INTACT)","RECRUITING","2026-08-31","2025-06","2025-06-24","2025-02-06","IDeA States Pediatric Clinical Trials Network","NETWORK",true,"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.","The INTACT trial is designed to address the need for interventions to improve neurodevelopmental outcomes in infants exposed to cannabinoids in utero. It is a multi-site pilot study conducted across three Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN) sites. The trial aims to evaluate the feasibility of the INTACT Intervention program, which focuses on training birthing parents in contingent responding to promote early language, cognitive, and social development in their infants.\n\nThe study intervention consists of 12 monthly INTACT intervention coaching sessions, each comprising online module completion followed by personalized coaching sessions with interventionists certified to deliver the Play and Learn Strategies (PALS) methodology, which forms the basis for the INTACT intervention. The online modules focus on strengthening effective parenting practices, while the coaching sessions guide birthing parents in contingent responding techniques, such as reading infant signals and responding with warm and sensitive behaviors. There are three objectives for this study, examining 1) Participant Recruitment, 2) Participant Completion, and 3) Participant Adherence.\n\nObjective 1 examines if birthing parents can be recruited and enrolled in the study. The endpoint of this objective is the percentage of potential participants approached for the study that are consented and determined to be eligible for study participation.\n\nObjective 2 evaluates participant completion, as measured by the percent of birthing parent\u002Finfant dyads that complete the coaching session scheduled when the child is 12 months of age.\n\nObjective 3 evaluates the number of individual INTACT intervention coaching sessions completed.\n\nThe study duration is planned for 22 months, including 1-4 months for study development and start-up, 3 months for enrollment, 12 months for the intervention, and 3 months for data organization, clean-up, and manuscript preparation.\n\nThe INTACT trial will not assess clinical outcomes but will inform the design of a future larger-scale clinical trial to evaluate the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids.",[19],"Developmental Delay",[21,22,23,24,25,26],"Behavioral health intervention","Prenatal substance exposure","Neurodevelopmental outcomes","Pediatric intervention","Developmental disorders","Pediatric health","INTERVENTIONAL","PREVENTION",[30],"NA",{"count":32,"type":33},20,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":41},"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.",[40],"Personalized coaching sessions",[42],"ePALS",[44,48,52],{"measure":45,"description":46,"timeFrame":47},"Percentage of approached participants that are eligible for study participation","Whether a potential participant approached for study participation will eventually be consented and determined to be eligible for study participation.","3 months",{"measure":49,"description":50,"timeFrame":51},"Percentage of participants that complete their final visit","Whether a birthing parent\u002Finfant dyad will complete the final coaching session when the child is 12 months of age.","12 months following enrollment",{"measure":53,"description":54,"timeFrame":51},"Percentage of participants that receive a sufficient number of coaching sessions","Whether a participant will complete the sufficient number of INTACT intervention coaching sessions, defined as completion of at least 8 out of 12 coaching sessions.",[],"ALL",null,"7 Days",{"inclusion":60,"exclusion":71,"raw_text":78},[61,62,63,64,65,66,67,68,69,70],"Age of majority, as defined by the state of residency","Cannabinoid use during pregnancy confirmed with self-report","Have the ability to speak, read, and understand English","Birthing parent who delivered at one of the hospitals where study team members have clinical privileges to access medical records","Has parental custody of the infant","Singleton pregnancy with live birth","Has an electronic device capable of watching videos and able to stream\u002Fdownload videos for viewing and permitting video conferencing","Has study access to the internet","Term infants at birth (\\>37 weeks' gestation)","Biological child of the birthing parent",[72,73,74,75,76,77],"Other illicit drug use, excluding cannabinoids, during pregnancy (such as heroin or cocaine) per self-reported or toxicology results","Opiate use (prescribed or unprescribed) per self-report or toxicology results during this pregnancy","Prolonged hospitalization following delivery longer than 7 days","Has major birth defect(s) including physical anomalies including limb malformations\u002Fabsence of limbs or chromosomal abnormalities","Diagnosed with neonatal encephalopathy, metabolic disorder, stroke, intracranial hemorrhage, or meningitis during birth hospitalization","Received any major surgical intervention during the birth hospitalization or required a prolonged birth hospitalization (prolonged hospitalization being any hospitalization longer than 7 days)","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)",[80],"CHILD",[82,99,117],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":96},"University of New Mexico Health Sciences Center","Albuquerque","New Mexico","87131","United States",[89,93],{"name":90,"role":91,"email":92},"Jessie Maxwell, MD","CONTACT","JRMaxwell@salud.unm.edu",{"name":94,"role":91,"email":95},"Sandra Beauman, MSN","SBeauman@salud.unm.edu",{"lat":97,"lon":98},35.08449,-106.65114,{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":87,"contacts":104,"geoPoint":114},"Avera Research Institute","Sioux Falls","South Dakota","57108",[105,108,112],{"name":106,"role":91,"email":107},"Maria Barber, DO","Maria.Barber@avera.org",{"name":109,"role":91,"phone":110,"email":111},"Meggie McCoy, BS","(605) 504-3154","Meggie.McCoy@avera.org",{"name":106,"role":113},"PRINCIPAL_INVESTIGATOR",{"lat":115,"lon":116},43.54369,-96.72796,{"facility":118,"status":8,"city":119,"state":120,"zip":121,"country":87,"contacts":122,"geoPoint":129},"University of Vermont Medical Center","Burlington","Vermont","05401",[123,126],{"name":124,"role":91,"email":125},"Leigh-Anne Cioffredi, MD","Leigh-Anne.Cioffredi@uvmhealth.org",{"name":127,"role":91,"email":128},"Laurie Chassereau, RN","laurie.chassereau@med.uvm.edu",{"lat":130,"lon":131},44.47588,-73.21207,[133,137],{"name":134,"role":91,"phone":135,"email":136},"Song Ounpraseuth, PhD","(501) 686-5647","STOunpraseuth@uams.edu",{"name":138,"role":91,"phone":135,"email":139},"Matthew Henry, MSc","mhenry3@uams.edu",[141,143,145],{"name":90,"affiliation":142,"role":113},"University of New Mexico",{"name":124,"affiliation":144,"role":113},"University of Vermont",{"name":106,"affiliation":100,"role":113},[147],{"pmid":148,"type":149,"citation":150},"40354465","DERIVED","Maxwell JR, Cioffredi LA, Talavera-Barber MM, Henry M, Beauman S, Hittson A, McCoy M, Chassereau L, Jin J, Abraham PA, Fu LY, Raissy H, Snowden JN. The protocol for a pilot feasibility trial of Improving Neurodevelopmental ouTcomes After prenatal Cannabinoid in uTero exposure (INTACT) study for a multi-center trial. PLoS One. 2025 May 12;20(5):e0322035. doi: 10.1371\u002Fjournal.pone.0322035. eCollection 2025.",[],{"nct_id":4,"conditions":153,"biomarkers":154},[19,22],[],{"nct_id":4,"found":15,"summary":156,"prompt_version":166},{"design":157,"status":158,"heading":159,"summary":160,"follow_up":161,"word_count":162,"commitments":163,"compensation":164,"drugs_mentioned":165},"This is a pilot study that will enroll 20 birthing parent\u002Finfant pairs across three different locations. It is an interventional study, meaning participants will receive a specific program.","completed","Improving Neurodevelopmental Outcomes After Prenatal Cannabinoid Exposure","This study, called INTACT, is looking at a program called Play and Learn Strategies (PALS) to help infants who were exposed to cannabinoids (like marijuana) before birth. The PALS program involves monthly online lessons and personalized coaching for birthing parents. These sessions are designed to help parents respond to their baby's needs in ways that can improve the baby's social and emotional development. We are enrolling 20 birthing parent\u002Finfant pairs. To join, birthing parents must have used cannabinoids during pregnancy, be able to speak English, and have delivered at certain hospitals. This study will check if it's possible to recruit participants, if they complete the study, and if they attend enough coaching sessions, rather than directly measuring the babies' development.","The study measures participant completion and coaching session adherence up to 12 months following enrollment.",120,"Participants will complete 12 monthly online modules and personalized coaching sessions. The study duration, including enrollment and intervention, is part of a 22-month overall project.","Not stated in the trial record.",[],"v2"]