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Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure

NCT06423664 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-24

No results posted yet for this study

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.

Conditions

  • Developmental Delay

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.

Sponsors & Collaborators

  • University of New Mexico

    collaborator OTHER

  • University of Vermont

    collaborator OTHER

  • Avera Research Institute

    collaborator UNKNOWN

  • National Institutes of Health (NIH)

    collaborator NIH

  • IDeA States Pediatric Clinical Trials Network

    lead NETWORK

Principal Investigators

  • Jessie Maxwell, MD · University of New Mexico

  • Leigh-Anne Cioffredi, MD · University of Vermont

  • Maria Barber, DO · Avera Research Institute

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
7 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-06
Primary Completion
2026-06-10
Completion
2026-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06423664 on ClinicalTrials.gov