Improving outcomes for infants exposed to cannabinoids during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The INTACT trial is a multisite pilot feasibility study aimed at evaluating the effectiveness of the INTACT Intervention program in enhancing neurodevelopmental outcomes in infants who were prenatally exposed to cannabinoids. This study will enroll 20 birthing parent/infant dyads across three sites and will focus on the feasibility of the intervention rather than clinical outcomes. The intervention consists of 12 monthly coaching sessions that train birthing parents in effective parenting practices and contingent responding techniques to support their infants' early development. The study will assess participant recruitment, completion, and adherence over a duration of 22 months.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Birthing Parent

* 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

Infant

* Term infants at birth (\>37 weeks' gestation)
* Biological child of the birthing parent

Exclusion Criteria:

Birthing Parent

* 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

Infant

* 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)

Where it's running

• University of New Mexico Health Sciences Center
  Albuquerque, New Mexico, United States Recruiting
• Avera Research Institute
  Sioux Falls, South Dakota, United States Recruiting
• University of Vermont Medical Center
  Burlington, Vermont, United States Recruiting

Study contacts

• Principal investigator: Jessie Maxwell, MD — University of New Mexico
• Study coordinator: Song Ounpraseuth, PhD
• Email: STOunpraseuth@uams.edu
• Phone: (501) 686-5647

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.