Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure

Official title

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

Overview

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.

Detailed description

The INTACT trial is designed to address the need for interventions to improve neurodevelopmental outcomes in infants exposed to cannabinoids in utero. It is a multi-site pilot study conducted across three Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN) sites. The trial aims to evaluate the feasibility of the INTACT Intervention program, which focuses on training birthing parents in contingent responding to promote early language, cognitive, and social development in their infants.

The study intervention consists of 12 monthly INTACT intervention coaching sessions, each comprising online module completion followed by personalized coaching sessions with interventionists certified to deliver the Play and Learn Strategies (PALS) methodology, which forms the basis for the INTACT intervention. The online modules focus on strengthening effective parenting practices, while the coaching sessions guide birthing parents in contingent responding techniques, such as reading infant signals and responding with warm and sensitive behaviors. There are three objectives for this study, examining 1) Participant Recruitment, 2) Participant Completion, and 3) Participant Adherence.

Objective 1 examines if birthing parents can be recruited and enrolled in the study. The endpoint of this objective is the percentage of potential participants approached for the study that are consented and determined to be eligible for study participation.

Objective 2 evaluates participant completion, as measured by the percent of birthing parent/infant dyads that complete the coaching session scheduled when the child is 12 months of age.

Objective 3 evaluates the number of individual INTACT intervention coaching sessions completed.

The study duration is planned for 22 months, including 1-4 months for study development and start-up, 3 months for enrollment, 12 months for the intervention, and 3 months for data organization, clean-up, and manuscript preparation.

The INTACT trial will not assess clinical outcomes but will inform the design of a future larger-scale clinical trial to evaluate the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids.

Interventions

• Behavioral 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 measures

• 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]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 3 centers

• University of New Mexico Health Sciences Center — Albuquerque
• Avera Research Institute — Sioux Falls
• University of Vermont Medical Center — Burlington

Publications

• Maxwell JR, Cioffredi LA, Talavera-Barber MM, Henry M, Beauman S, Hittson A, McCoy M, Chassereau L, Jin J, Abraham PA, Fu LY, Raissy H, Snowden JN. The protocol for a pilot feasibility trial of Improving Neurodevelopmental ouTcomes After prenatal Cannabinoid in uTero exposure (INTACT) study for a multi-center trial. PLoS One. 2025 May 12;20(5):e0322035. doi: 10.1371/journal.pone.0322035. eCollecti PMID 40354465

Identifiers

NCT: NCT06423664 · 276534 · U24OD024957

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗