Clinical trial NCT06423664: Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure
Official title: Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (INTACT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Developmental Delay
Keywords: Behavioral health intervention
Prenatal substance exposure
Neurodevelopmental outcomes
Pediatric intervention
Developmental disorders
Pediatric health
Lead sponsor: IDeA States Pediatric Clinical Trials Network
Sponsor class: NETWORK
Collaborators: name: University of New Mexico
name: University of Vermont
name: Avera Research Institute
name: National Institutes of Health (NIH)
First posted: 2024-05-21
Enrollment: 20
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm pilot study to assess feasibility of study procedures.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of approached participants that are eligible for study participation
timeFrame: 3 months
measure: Percentage of participants that complete their final visit
timeFrame: 12 months following enrollment
measure: Percentage of participants that receive a sufficient number of coaching sessions
timeFrame: 12 months following enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: University of New Mexico
name: Jessie Maxwell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Vermont
name: Leigh-Anne Cioffredi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Avera Research Institute
name: Maria Barber, DO
role: PRINCIPAL_INVESTIGATOR
References: