Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure

Developmental Delay Clinical Trial

— INTACT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06423664
• Other study ID #: 276534
• Secondary ID: U24OD024957
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 17, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2024
• Source: IDeA States Pediatric Clinical Trials Network
• Contact: Song Ounpraseuth, PhD
• Phone: (501) 686-5647
• Email: STOunpraseuth[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 7 Days

Eligibility

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)

Related Conditions & MeSH terms

• Developmental Delay

Intervention

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.

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Avera Research Institute	Sioux Falls	South Dakota

Sponsors (5)

Lead Sponsor	Collaborator
IDeA States Pediatric Clinical Trials Network	Avera Research Institute, National Institutes of Health (NIH), University of New Mexico, University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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