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Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure
Sponsor: 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.
Official title: Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (INTACT)
Key Details
Gender
All
Age Range
Any - 7 Days
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-02-06
Completion Date
2026-08-31
Last Updated
2025-06-24
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (3)
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Avera Research Institute
Sioux Falls, South Dakota, United States
University of Vermont Medical Center
Burlington, Vermont, United States