๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-06-23

Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (NCT06423664)

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

๐ŸŸข Recruiting Observational / Diagnostic ๐Ÿง  Behavioral & Psychological Program Sponsor: IDeA States Pediatric Clinical Trials Network

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: University of New Mexico Health Sciences Center โ€” Albuquerque, New Mexico

Age range: Not specified to 7 Days

๐Ÿงช Interventions in This Study

  • Play and Learn Strategies (PALS) Program (BEHAVIORAL)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (3 Sites)

  • University of New Mexico Health Sciences Center โ€” Albuquerque, New Mexico
  • Avera Research Institute โ€” Sioux Falls, South Dakota
  • University of Vermont Medical Center โ€” Burlington, Vermont

๐Ÿ“ž Contact the Study Coordinator

Phone: (501) 686-5647

Email: STOunpraseuth@uams.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—