Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (INTACT)

June 23, 2025 updated by: IDeA States Pediatric Clinical Trials Network

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • ePALS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of approached participants that are eligible for study participation
Time Frame: 3 months
Whether a potential participant approached for study participation will eventually be consented and determined to be eligible for study participation.
3 months
Percentage of participants that complete their final visit
Time Frame: 12 months following enrollment
Whether a birthing parent/infant dyad will complete the final coaching session when the child is 12 months of age.
12 months following enrollment
Percentage of participants that receive a sufficient number of coaching sessions
Time Frame: 12 months following enrollment
Whether a participant will complete the sufficient number of INTACT intervention coaching sessions, defined as completion of at least 8 out of 12 coaching sessions.
12 months following enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IDeA States Pediatric Clinical Trials Network

Collaborators

National Institutes of Health (NIH)
University of Vermont
University of New Mexico
Avera Research Institute

Investigators

  • Principal Investigator: Jessie Maxwell, MD, University of New Mexico
  • Principal Investigator: Leigh-Anne Cioffredi, MD, University of Vermont
  • Principal Investigator: Maria Barber, DO, Avera Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2025

Primary Completion (Estimated)

June 10, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 276534
  • U24OD024957 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will conduct this trial in accordance with the following publication and data sharing policies and regulations:

NIH Public Access Policy. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication.

ECHO ISPCTN Publications and Presentations Policy. It ensures accurate, responsible, and efficient communication of findings from ECHO ISPCTN clinical trials.

NIH Data Sharing Policy and the policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Resulting Information Submission Rule. Other researchers may request data from this trial by contacting Song Ounpraseugh, PhD, at the ISPCTN Data Coordinating and Operations Center (DCOC).

IPD Sharing Time Frame

Per data sharing polices of NIH and the ISPCTN

IPD Sharing Access Criteria

to be announced

IPD Sharing Supporting Information Type

  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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