Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
IDeA States Pediatric Clinical Trials Network
Study ID
NCT06423664
Status
Recruiting
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Conditions

  • Developmental Delay

Eligibility Criteria

Sex
ALL
Age
N/A - 7 Days
Healthy Volunteers
Accepted

Interventions

  • Play and Learn Strategies (PALS) Program — BEHAVIORAL
    Monthly modules and personalized coaching sessions designed to strengthen maternal responsiveness and sensitivity which, in turn, improves infant social-emotional behavior and development outcomes.

Study Details

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.

Key Dates

Start date
Feb 6, 2025
Status verified
Jun 2025
Primary completion
Jun 10, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Personalized coaching sessions
    A novel program to train birthing parents in contingent responding with the goal of improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. 1 personalized coaching session per month for 12 months.

Primary Outcome Measure

Percentage of approached participants that are eligible for study participation [ Time Frame: 3 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of New Mexico Health Sciences CenterAlbuquerqueNew Mexico87131
Jessie Maxwell, MD
[email protected]
Sandra Beauman, MSN
[email protected]
Avera Research InstituteSioux FallsSouth Dakota57108
Maria Barber, DO
[email protected]
Meggie McCoy, BS
[email protected]
(605) 504-3154
Maria Barber, DO (PRINCIPAL_INVESTIGATOR)
University of Vermont Medical CenterBurlingtonVermont05401
Leigh-Anne Cioffredi, MD
[email protected]
Laurie Chassereau, RN
[email protected]

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University of New Mexico Health Sciences Center· Albuquerque, NMAvera Research Institute· Sioux Falls, SDUniversity of Vermont Medical Center· Burlington, VT

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