Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (INTACT)
IDeA States Pediatric Clinical Trials Network
Summary
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.
Description
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. The study intervention consists of 12 monthly INTACT intervention coachi…
Eligibility
- Age range
- Up to 0 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: Birthing Parent * 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/download videos for viewing and permitting video conferencing * Has study access to the internet Infant…
Interventions
- BehavioralPlay 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.
Locations (3)
- University of New Mexico Health Sciences CenterAlbuquerque, New Mexico
- Avera Research InstituteSioux Falls, South Dakota
- University of Vermont Medical CenterBurlington, Vermont