Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After prenatal Cannabinoid in uTero exposure (INTACT)
Learn more about the INTACT study HERE.
This is a pilot study to assess the feasibility of using the INTACT Intervention to train birthing parents (biological parents who gave birth to the infant) through coaching sessions with the goal of improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids.
INTACT is a multicenter trial as part of the ECHO Program IDeA States Pediatric Network (ISPCTN), designed and led by Jessie Maxwell, MD, MBA from the University of New Mexico. The study takes place in three ISPCTN states that serve rural and underserved children and families, assessing the following variables: participant recruitment, participant involvement and completion of the intervention when the infant is 12 months of age, and the number of overall INTACT intervention coaching sessions completed. The study duration will be 23 months.
Information gained from this study will inform a future randomized controlled trial, at which time a clinical outcome assessment (the Bayley Scales of Infant and Toddler Development Screening Test, 4th Edition (Bayley-IV)) will be completed at 2 years of age.
Questions
Questions about ECHO's involvement in the INTACT Study can be directed to the Program Office.
Protocol Chair
List of INTACT Sites and Funded Institutions
Additional information for the participating sites can be found here.
| NM | New Mexico |
| SD | South Dakota |
| VT | Vermont |