Actively Recruiting

Phase Not Applicable
Age: 0 - 7Days
All Genders
Healthy Volunteers
ID06423664

Pilot Feasibility Trial of Improving Neurodevelopmental Outcomes After Prenatal Cannabinoid Exposure with the INTACT Intervention

Led by IDeA States Pediatric Clinical Trials Network · Updated on 2025-06-24

20

Participants Needed

3

Research Sites

11 weeks

Total Duration

On this page

Sponsors

I

IDeA States Pediatric Clinical Trials Network

Lead Sponsor

U

University of New Mexico

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the INTACT Intervention program to support neurodevelopment in infants who were exposed to cannabinoids before birth. This multisite pilot feasibility study aims to test how well the program can be delivered and followed by participants, rather than measuring clinical outcomes. The research involves 20 birthing parent and infant pairs across three sites, with the study lasting 22 months including start-up, enrollment, intervention, and data analysis phases. The intervention includes 12 monthly coaching sessions for birthing parents, combining online modules with personalized coaching based on the Play and Learn Strategies (PALS) method. These sessions focus on improving parenting skills such as recognizing infant signals and responding warmly to promote early language, cognitive, and social development. The study tracks recruitment success, completion rates of coaching sessions, and overall adherence to the program. Participants will engage in monthly coaching for one year, with assessments focusing on recruitment numbers, session completion, and adherence to the intervention. Researchers collect data on how many participants complete the study and receive enough coaching sessions. The study does not assess infant clinical outcomes but will provide information for planning a larger future trial. Total study involvement spans up to 22 months from start to finish.

CONDITIONS

Brief Title

Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure

Who Can Participate

Age: 0 - 7Days
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Birthing parent of legal adult age as defined by state
  • Confirmed cannabinoid use during pregnancy by self-report
  • Ability to speak, read, and understand English
  • Delivered at a hospital where study team has access to medical records
  • Has parental custody of the infant
  • Singleton pregnancy resulting in live birth
  • Has an electronic device capable of streaming videos and video conferencing
  • Has internet access for study participation
  • Infant born at term (over 37 weeks gestation)
  • Infant is biological child of the birthing parent
Not Eligible

You will not qualify if you...

  • Use of illicit drugs other than cannabinoids during pregnancy
  • Opiate use during pregnancy by self-report or toxicology
  • Prolonged hospitalization of birthing parent after delivery over 7 days
  • Infant with major birth defects or physical anomalies
  • Infant diagnosed with serious neurological or metabolic disorders during birth hospitalization
  • Infant had major surgery or prolonged birth hospitalization over 7 days

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) for eligibility assessment

Treatment

Duration - 12 months

Participants take part in the INTACT intervention program consisting of monthly online modules and personalized coaching sessions to promote early language, cognitive, and social development in their infants.

12 coaching sessions, 1 per month (online and/or remote)

Trial Site Locations

Total: 3 locations

1

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States, 87131

Actively Recruiting

2

Avera Research Institute

Sioux Falls, South Dakota, United States, 57108

Actively Recruiting

3

University of Vermont Medical Center

Burlington, Vermont, United States, 05401

Actively Recruiting

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Research Team

S

Song Ounpraseuth, PhD

M

Matthew Henry, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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Published Research Related To This Trial

The protocol for a pilot feasibility trial of Improving Neurodevelopmental ouTcomes After prenatal Cannabinoid in uTero exposure (INTACT) study for a multi-center trial.

Jessie R Maxwell, Leigh-Anne Cioffredi, Maria M Talavera-Barber...

https://pubmed.ncbi.nlm.nih.gov/40354465