RecruitingNot ApplicableNCT06423664

Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure

Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (INTACT)

Sponsor

IDeA States Pediatric Clinical Trials Network

Enrollment

20 participants

Start Date

Feb 6, 2025

Study Type

INTERVENTIONAL

Conditions

developmental delay

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

Max Age: 7 Days

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Play and Learn Strategies (PALS) Program for people with developmental delay. The study is currently recruiting participants at 3 locations. People eligible for this study include up to age 7 Days.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.