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RECRUITING
NCT06423664
NA

Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure

Sponsor: IDeA States Pediatric Clinical Trials Network

View on ClinicalTrials.gov

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

Interventions

BEHAVIORAL

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