Navigation Study: Durham

Summary

The purpose of this RCT is to evaluate the implementation and impact of a new, community-wide prevention program, "Community Navigation", on maternal and child health and well-being. This program recruits mothers at the OB/GYN or pediatrician's office prenatally and provides up to six Navigation visits (prenatally, and at child ages 12, 24, 36, 48, and 60 months) to assess family strengths and needs, establish connections between the family and primary health care or other community providers based on identified needs and family preference, and then follows up one month later to confirm these referrals.

Conditions

• Prenatal; Postnatal

Interventions

BEHAVIORAL

Navigation Intervention Version 1.0 (discontinued, modified to Version 2.0. Data will not be used)

Navigation 1.0 recruits mothers in OB/GYN (prenatal) offices, provides up to three Navigation visits, 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.

BEHAVIORAL

Control Intervention

Brief educational information will be provided about pregnancy (provided prenatally) and child development when the child is approximately 12, 24, 36, 48, and 60 months old.

BEHAVIORAL

Navigation Intervention Version 2.0

Navigation 2.0 recruits mothers in OB/GYN offices. Mothers are offered visits from a Navigator prenatally and postnatally (at child ages 12, 24, 36, 48, and 60 months). During visits, the Navigator works with the mother/caregiver to identify family needs, establishes connections between the family and community providers, and follows up one month later to confirm these referrals. At all touch points, Navigators assess and support family needs in four domains. For the prenatal, 12, and 24 month Navigation visits, the domains include (1) Health Care; (2) Caring for the Infant; (3) A Safe Home; and (4) Parent Well-Being. At the 36, 48, and 60 month Navigation visits, the domains include: (1) Health Care; (2) Caring for the Child; (3) Child Development; and (4) Family Interactions. Families are also invited at all visits to nominate other needs not related to these four domains.

Sponsors & Collaborators

• Duke University

  lead OTHER

Principal Investigators

• Kenneth Dodge, PhD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-20

Primary Completion

2030-06-30

Completion

2030-06-30

Countries

• United States

Study Locations