## Protocol Section
### Identification Module
**NCT ID:** NCT06423664

**Acronym:** INTACT

**Brief Title:** 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)

#### Organization Study ID Info
**ID:** 276534
#### Organization
**Class:** NETWORK
**Full Name:** IDeA States Pediatric Clinical Trials Network
### Status Module
#### Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-17

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of New Mexico

**Class:** OTHER

**Name:** University of Vermont

**Class:** UNKNOWN

**Name:** Avera Research Institute

**Class:** NIH

**Name:** National Institutes of Health (NIH)

#### Lead Sponsor

**Class:** NETWORK

**Name:** IDeA States Pediatric Clinical Trials Network

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Developmental Delay

**Keywords:**

- Infants exposed to cannabinoids in-utero and their birthing parent.

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** A single-arm pilot study to assess feasibility of study procedures.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Behavioral: Play and Learn Strategies (PALS) Program

**Label:** Personalized coaching sessions

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Personalized coaching sessions

**Description:** Monthly modules and personalized coaching sessions designed to strengthen maternal responsiveness and sensitivity which, in turn, improves infant social-emotional behavior and development outcomes.

**Name:** Play and Learn Strategies (PALS) Program

**Other Names:**

- ePALS

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Whether a potential participant approached for study participation will eventually be consented and determined to be eligible for study participation.

**Measure:** Participant Recruitment

**Time Frame:** 3 months

**Description:** Whether a birthing parent/infant dyad will complete the final coaching session when the child is 12 months of age.

**Measure:** Participant Completion

**Time Frame:** 12 months following enrollment

**Description:** 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.

**Measure:** Participant Adherence

**Time Frame:** 12 months following enrollment

### Eligibility Module

**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)

**Healthy Volunteers:** True

**Maximum Age:** 7 Days

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jsnowden@uams.edu

**Name:** Jessica Snowden, MD

**Phone:** (501) 686-5647

**Role:** CONTACT

**Contact 2:**

**Email:** mhenry3@uams.edu

**Name:** Matthew Henry, MSc

**Phone:** (501) 686-5647

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Albuquerque

**Contacts:**

***Contact 1:***

- **Email:** JRMaxwell@salud.unm.edu

- **Name:** Jessie Maxwell, MD

- **Role:** CONTACT

***Contact 2:***

- **Email:** SBeauman@salud.unm.edu

- **Name:** Sandra Beauman, MSN

- **Role:** CONTACT

**Country:** United States

**Facility:** University of New Mexico Health Sciences Center

**State:** New Mexico

**Zip:** 87131

**Location 2:**

**City:** Sioux Falls

**Contacts:**

***Contact 1:***

- **Email:** Maria.Barber@avera.org

- **Name:** Maria Barber, DO

- **Role:** CONTACT

***Contact 2:***

- **Email:** Meggie.McCoy@avera.org

- **Name:** Meggie McCoy, BS

- **Phone:** (605) 504-3154

- **Role:** CONTACT

***Contact 3:***

- **Name:** Maria Barber, DO

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Avera Research Institute

**State:** South Dakota

**Zip:** 57108

**Location 3:**

**City:** Burlington

**Contacts:**

***Contact 1:***

- **Email:** Leigh-Anne.Cioffredi@uvmhealth.org

- **Name:** Leigh-Anne Cioffredi, MD

- **Role:** CONTACT

***Contact 2:***

- **Email:** laurie.chassereau@med.uvm.edu

- **Name:** Laurie Chassereau, RN

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Vermont Medical Center

**State:** Vermont

**Zip:** 05401

#### Overall Officials

**Official 1:**

**Affiliation:** University of New Mexico

**Name:** Jessie Maxwell, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of Vermont

**Name:** Leigh-Anne Cioffredi, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Avera Research Institute

**Name:** Maria Barber, DO

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** University of Arkansas

**Name:** Song Ounpraseuth, PhD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Access Criteria:** to be announced

**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).

**Info Types:**

- SAP

- ICF

**IPD Sharing:** YES

**Time Frame:** Per data sharing polices of NIH and the ISPCTN

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
