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/infant 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.
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
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/absence of limbs or chromosomal abnormalities
IDeA States Pediatric Clinical Trials Network
Lead sponsor
University of New Mexico
Collaborator
University of Vermont
Collaborator
Avera Research Institute
Collaborator
National Institutes of Health (NIH)
Collaborator