NCT06423664

Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: IDeA States Pediatric Clinical Trials Network · Network
• Sex: All
• Age: 7 Days
• Healthy volunteers: Accepted

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.

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.

Conditions

• Developmental Delay

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-06
• Primary completion: 2026-06-10
• Completion: 2026-08-31
• First posted: 2024-05-21
• Last updated: 2025-06-24

Locations

3 sites across 1 country: United States