Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure
INTACT
Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (INTACT)
2 other identifiers
interventional
20
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2025
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2024
CompletedFirst Posted
Study publicly available on registry
May 21, 2024
CompletedStudy Start
First participant enrolled
February 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
June 24, 2025
June 1, 2025
1.3 years
May 16, 2024
June 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of approached participants that are eligible for study participation
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
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
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
Study Arms (1)
Personalized coaching sessions
EXPERIMENTALA 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
Monthly modules and personalized coaching sessions designed to strengthen maternal responsiveness and sensitivity which, in turn, improves infant social-emotional behavior and development outcomes.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IDeA States Pediatric Clinical Trials Networklead
- University of New Mexicocollaborator
- University of Vermontcollaborator
- Avera Research Institutecollaborator
- National Institutes of Health (NIH)collaborator
Study Sites (3)
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131, United States
Avera Research Institute
Sioux Falls, South Dakota, 57108, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Related Publications (1)
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. eCollection 2025.
PMID: 40354465DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2024
First Posted
May 21, 2024
Study Start
February 6, 2025
Primary Completion (Estimated)
June 10, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
June 24, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ICF
- Time Frame
- Per data sharing polices of NIH and the ISPCTN
- Access Criteria
- to be announced
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).