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
Single group
Play and Learn Strategies (PALS) Program
BehavioralMonthly modules and personalized coaching sessions designed to strengthen maternal responsiveness and sensitivity which, in turn, improves infant social-emotional behavior and development outcomes.
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.
Percentage of participants that complete their final visit
Whether a birthing parent/infant dyad will complete the final coaching session when the child is 12 months of age.
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.
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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
