Recruiting

Cannabinoid

Sponsor:

IDeA States Pediatric Clinical Trials Network

Code:

NCT06423664

Conditions

Developmental Delay

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Play and Learn Strategies (PALS) Program

Study Details

Brief summary:

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.

Conditions

Developmental Delay

Study ID

NCT06423664

Start date

Feb 6, 2025

Status verified date

Jun, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Jun 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Play and Learn Strategies (PALS) Program

Monthly modules and personalized coaching sessions designed to strengthen maternal responsiveness and sensitivity which, in turn, improves infant social-emotional behavior and development outcomes.

Primary outcome measure

  • Percentage of approached participants that are eligible for study participation [ Time Frame: 3 months ]
  • Percentage of participants that complete their final visit [ Time Frame: 12 months following enrollment ]
  • Percentage of participants that receive a sufficient number of coaching sessions [ Time Frame: 12 months following enrollment ]

Central Contacts and Locations

Central contacts

Song Ounpraseuth, PhD

(501) 686-5647STOunpraseuth@uams.edu

Matthew Henry, MSc

(501) 686-5647mhenry3@uams.edu

Locations

University of New Mexico Health Sciences Center

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Jessie Maxwell, MD

JRMaxwell@salud.unm.edu

Sandra Beauman, MSN

SBeauman@salud.unm.edu

Avera Research Institute

Recruiting

Sioux Falls, South Dakota, United States, 57108

Contacts

Maria Barber, DO

Maria.Barber@avera.org

Meggie McCoy, BS

(605) 504-3154Meggie.McCoy@avera.org

Principal Investigator:

Maria Barber, DO

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Leigh-Anne Cioffredi, MD

Leigh-Anne.Cioffredi@uvmhealth.org

Laurie Chassereau, RN

laurie.chassereau@med.uvm.edu

More Information

Sponsor

IDeA States Pediatric Clinical Trials Network

Last update posted

Jun 24, 2025

Last verified

Jun, 2025

Keywords

  • Behavioral health intervention
  • Prenatal substance exposure
  • Neurodevelopmental outcomes
  • Pediatric intervention
  • Developmental disorders
  • Pediatric health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IDeA States Pediatric Clinical Trials Network on 2025-06-24.