Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure
Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (INTACT)
IDeA States Pediatric Clinical Trials Network
20 participants
Feb 6, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria12
- 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
- Term infants at birth (>37 weeks' gestation)
- Biological child of the birthing parent
Exclusion Criteria8
- Birthing Parent
- 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
- Infant
- Has major birth defect(s) including physical anomalies including limb malformations/absence of limbs or chromosomal abnormalities
- Diagnosed with neonatal encephalopathy, metabolic disorder, stroke, intracranial hemorrhage, or meningitis during birth hospitalization
- Received any major surgical intervention during the birth hospitalization or required a prolonged birth hospitalization (prolonged hospitalization being any hospitalization longer than 7 days)
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Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06423664