Navigation Study: Durham

Duke University

Status: Active, not recruiting

Conditions: Prenatal; Postnatal

Treatments: Behavioral: Control Intervention; Behavioral: Navigation Intervention Prenatal 1.0 (intervention discontinued, modified to 2.0. Data will not be used); Behavioral: Navigation Intervention Prenatal 2.0

Study type: Interventional

Funder types: Other

Identifiers

NCT04438031

Pro00104042

Details and patient eligibility

About

The purpose of the proposed study is to evaluate the implementation and impact of a new, community-wide prevention program, "Navigation", on maternal and infant health and well-being. This program recruits mothers at the OB/GYN or pediatrician's office and provides up to several visits (prenatally, 12 months, 24 months, and 36 months) to assess family needs, establishes connections between the family and primary health care or other community providers, and then follows up one month later to confirm these referrals.

Full description

Of note, 400 families were enrolled under Navigation 1.0, however, their data will not be included in any analysis due to the design changes (Navigation 2.0). The anticipated total of 800 subjects is specific to the 2.0 enrollment.

Enrollment: 815 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Families will be eligible for the study if they go to the certain OB/GYN offices (to be updated later) for their first prenatal visit
• Families will be eligible for the study if they go to the Roxboro Road Pediatric Care Practice for their child's 12-, 24-, or 36-month well visit
• Primary language is English or Spanish

Exclusion criteria

• Families residing outside of Durham County
• Families that are planning to move out of either county within the next 2 months at the time of recruitment
• Families will also be ineligible if the parent has a cognitive impairment that impairs their ability to consent/participate.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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815 participants in 3 patient groups

Navigation Intervention Prenatal 1.0 (arm closed and modified to 2.0 design. Data will not be used)

Experimental group

Description:

This program recruits mothers in OB/GYN (prenatal) offices, provides up to three Navigation visits (using prenatal navigation version 1.0), establishes connections between the family and primary health care or other community providers, and then follows up one month later to confirm these referrals. Navigators will assess and support family needs across multiple developmentally-appropriate domains at each age. Prenatally, the domains include support for (1) health and access to healthcare, (2) adjustments to pregnancy, (3) household and material needs, and (4) family safety. At 12, 24, and 36 months, the domains include support for (1) child basic needs, (2) parenting and child behavior, (3) child health and development, and (4) parent health and well-being.

Treatment:

Behavioral: Navigation Intervention Prenatal 1.0 (intervention discontinued, modified to 2.0. Data will not be used)

Control Intervention

Other group

Description:

Brief educational information will be provided about pregnancy (provided prenatally) and child development at 12, 24, and 36 months.

Treatment:

Behavioral: Control Intervention

Navigation Intervention Prenatal 2.0

Experimental group

Description:

This program recruits mothers in OB/GYN offices. Mothers are offered visits from a Navigator prenatally and postnatally (12-, 24-, and 36-months). During visits, the Navigator works with the mother to identify family needs, establishes connections between the family and community providers, and follows up one month later to confirm these referrals. Navigators assess and support family needs across 13 factors: caregiver health, infant health, healthcare plans, childcare plans, parent-child relationship, management of infant crying/behavior, household safety/material supports, family/community violence, history of parenting difficulties, parent well-being, substance use, parent emotional support, and other needs not related to first 12 factors. Navigation 2.0 is a revision of 1.0 in which adjustments to the protocol were made to improve guidance for Community Navigators and aid their assessments of family needs.

Treatment:

Behavioral: Navigation Intervention Prenatal 2.0