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Improving Neurodevelopmental Outcomes After Prenatal Cannabinoid Exposure

This study, called INTACT, is looking at a program called Play and Learn Strategies (PALS) to help infants who were exposed to cannabinoids (like marijuana) before birth. The PALS program involves monthly online lessons and personalized coaching for birthing parents. These sessions are designed to help parents respond to their baby's needs in ways that can improve the baby's social and emotional development. We are enrolling 20 birthing parent/infant pairs. To join, birthing parents must have used cannabinoids during pregnancy, be able to speak English, and have delivered at certain hospitals. This study will check if it's possible to recruit participants, if they complete the study, and if they attend enough coaching sessions, rather than directly measuring the babies' development.

Study design
This is a pilot study that will enroll 20 birthing parent/infant pairs across three different locations. It is an interventional study, meaning participants will receive a specific program.
What's involved
Participants will complete 12 monthly online modules and personalized coaching sessions. The study duration, including enrollment and intervention, is part of a 22-month overall project.
Compensation
Not stated in the trial record.
Follow-up
The study measures participant completion and coaching session adherence up to 12 months following enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06423664

Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure

Recruiting
NAUp to 7InterventionalPrevention
IDeA States Pediatric Clinical Trials Network
~20 participants
Updated 2025-06-24 on ClinicalTrials.gov
What's tested:Play and Learn Strategies (PALS) Program

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of approached participants that are eligible for study participation
Measured over 3 months
+2 more outcomes measured

Conditions

Developmental Delay

Explore related trials

Developmental DelayPrenatal substance exposure

NCT06423664

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Avera Research Institute

    Sioux Falls, South Dakotastudy coordinator listed

    Recruiting

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexicostudy coordinator listed

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermontstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jessie Maxwell, MD · PRINCIPAL_INVESTIGATOR · University of New Mexico
  • Leigh-Anne Cioffredi, MD · PRINCIPAL_INVESTIGATOR · University of Vermont
  • Maria Barber, DO · PRINCIPAL_INVESTIGATOR · Avera Research Institute

Who to contact

Song Ounpraseuth, PhD
[email protected]
(501) 686-5647
Email the study team

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Eligibility criteria

Inclusion

Age of majority, as defined by the state of residency
Cannabinoid use during pregnancy confirmed with self-report
Have the ability to speak, read, and understand English
Birthing parent who delivered at one of the hospitals where study team members have clinical privileges to access medical records
Has parental custody of the infant
Singleton pregnancy with live birth
Has an electronic device capable of watching videos and able to stream/download videos for viewing and permitting video conferencing
Has study access to the internet
Term infants at birth (\>37 weeks' gestation)
Biological child of the birthing parent

Exclusion

Other illicit drug use, excluding cannabinoids, during pregnancy (such as heroin or cocaine) per self-reported or toxicology results
Opiate use (prescribed or unprescribed) per self-report or toxicology results during this pregnancy
Prolonged hospitalization following delivery longer than 7 days
Has major birth defect(s) including physical anomalies including limb malformations/absence of limbs or chromosomal abnormalities
Diagnosed with neonatal encephalopathy, metabolic disorder, stroke, intracranial hemorrhage, or meningitis during birth hospitalization
Received any major surgical intervention during the birth hospitalization or required a prolonged birth hospitalization (prolonged hospitalization being any hospitalization longer than 7 days)

What this trial measures

  • Percentage of approached participants that are eligible for study participation3 months

    Whether a potential participant approached for study participation will eventually be consented and determined to be eligible for study participation.

  • Percentage of participants that complete their final visit12 months following enrollment

    Whether a birthing parent/infant dyad will complete the final coaching session when the child is 12 months of age.

  • Percentage of participants that receive a sufficient number of coaching sessions12 months following enrollment

    Whether a participant will complete the sufficient number of INTACT intervention coaching sessions, defined as completion of at least 8 out of 12 coaching sessions.