Improving outcomes for infants exposed to cannabinoids during pregnancy
Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (INTACT)
NA · IDeA States Pediatric Clinical Trials Network · NCT06423664
This study is trying out a coaching program for parents to see if it helps improve the development of infants who were exposed to cannabinoids before birth.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | N/A to 7 Days |
| Sex | All |
| Sponsor | IDeA States Pediatric Clinical Trials Network (network) |
| Locations | 3 sites (Albuquerque, New Mexico and 2 other locations) |
| Trial ID | NCT06423664 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include birthing parents who used cannabinoids during pregnancy and have a singleton live birth infant who is at least 37 weeks gestation.
Not a fit: Patients who used other illicit drugs or opiates during pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve early language, cognitive, and social development in infants exposed to cannabinoids in utero.
How similar studies have performed: While this approach is novel in its specific focus on cannabinoid exposure, similar interventions targeting developmental outcomes in at-risk populations have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Albuquerque, New Mexico and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Developmental Delay, Behavioral health intervention, Prenatal substance exposure, Neurodevelopmental outcomes, Pediatric intervention, Developmental disorders, Pediatric health