Clinical trial NCT04438031: Navigation Study: Durham
Official title: Evaluation of the Navigation Prevention Program: Durham
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prenatal; Postnatal
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 815
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the implementation by the rate of enrollment in the Navigation program.
timeFrame: Prenatally (up until delivery of target child)
measure: Evaluate the implementation by the rate of retention in the Navigation program.
timeFrame: 12 months
measure: Evaluate the implementation by the rate of retention in the Navigation program.
timeFrame: 24 months
measure: Evaluate the implementation by the rate of retention in the Navigation program.
timeFrame: 36 months
measure: Evaluate the implementation by the fidelity of implementation of the Navigation manual by Navigators.
timeFrame: 12 months
measure: Evaluate the implementation by the fidelity of implementation of the Navigation manual by Navigators.
timeFrame: 24 months
measure: Evaluate the implementation by the fidelity of implementation of the Navigation manual by Navigators.
timeFrame: 36 months
measure: Evaluate the implementation by the proportion of families receiving screening scores that indicate risk for negative child and/or family outcomes.
timeFrame: Prenatal (before delivery of target child)
measure: Evaluate the implementation by the proportion of families receiving screening scores that indicate risk for negative child and/or family outcomes.
timeFrame: 12 months
measure: Evaluate the implementation by the proportion of families receiving screening scores that indicate risk for negative child and/or family outcomes.
timeFrame: 24 months
measure: Evaluate the implementation by the proportion of families receiving screening scores that indicate risk for negative child and/or family outcomes.
timeFrame: 36 months
measure: Evaluate the implementation by the proportion of families referred to community resources.
timeFrame: Prenatally (before delivery of target child)
measure: Evaluate the implementation by the proportion of families referred to community resources.
timeFrame: 12 months
measure: Evaluate the implementation by the proportion of families referred to community resources.
timeFrame: 24 months
measure: Evaluate the implementation by the proportion of families referred to community resources.
timeFrame: 36 months
measure: Evaluate the implementation by the proportion of families that initiate community services.
timeFrame: Prenatally (before delivery of target child)
measure: Evaluate the implementation by the proportion of families that initiate community services.
timeFrame: 12 months
measure: Evaluate the implementation by the proportion of families that initiate community services.
timeFrame: 24 months
measure: Evaluate the implementation by the proportion of families that initiate community services.
timeFrame: 36 months
measure: Evaluate the implementation by the families' satisfaction with the Navigation program.
timeFrame: 3 months
measure: Evaluate the implementation by the families' satisfaction with the Navigation program.
timeFrame: 15 months
measure: Evaluate the implementation by the families' satisfaction with the Navigation program.
timeFrame: 27 months
measure: Evaluate the implementation by the families' satisfaction with the Navigation program.
timeFrame: 39 months
measure: Evaluate the impact of the Navigation program by reviewing child maltreatment.
timeFrame: 12 months
measure: Evaluate the impact of the Navigation program by reviewing child maltreatment.
timeFrame: 24 months
measure: Evaluate the impact of the Navigation program by reviewing child maltreatment.
timeFrame: 36 months
measure: Evaluate the impact of the Navigation program by reviewing child maltreatment.
timeFrame: 48 months
measure: Evaluate the impact of the Navigation program by reviewing child maltreatment.
timeFrame: 60 months
measure: Evaluate the impact of the Navigation program by reviewing maternal health.
timeFrame: 3 months
measure: Evaluate the impact of the Navigation program by reviewing maternal health.
timeFrame: 15 months
measure: Evaluate the impact of the Navigation program by reviewing maternal health.
timeFrame: 27 months
measure: Evaluate the impact of the Navigation program by reviewing maternal health.
timeFrame: 39 months
measure: Evaluate the impact of the Navigation program by reviewing maternal health.
timeFrame: 51 months
measure: Evaluate the impact of the Navigation program by reviewing maternal health.
timeFrame: 63 months
measure: Evaluate the impact of the Navigation program by reviewing child health and development.
timeFrame: 3 months
measure: Evaluate the impact of the Navigation program by reviewing child health and development.
timeFrame: 15 months
measure: Evaluate the impact of the Navigation program by reviewing child health and development.
timeFrame: 27 months
measure: Evaluate the impact of the Navigation program by reviewing child health and development.
timeFrame: 39 months
measure: Evaluate the impact of the Navigation program by reviewing child health and development.
timeFrame: 51 months
measure: Evaluate the impact of the Navigation program by reviewing child health and development.
timeFrame: 63 months
measure: Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.
timeFrame: 3 months
measure: Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.
timeFrame: 15 months
measure: Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.
timeFrame: 27 months
measure: Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.
timeFrame: 39 months
measure: Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.
timeFrame: 51 months
measure: Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.
timeFrame: 63 months
measure: Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.
timeFrame: 3 months
measure: Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.
timeFrame: 15 months
measure: Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.
timeFrame: 27 months
measure: Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.
timeFrame: 39 months
measure: Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.
timeFrame: 51 months
measure: Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.
timeFrame: 63 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Kenneth Dodge, PhD
role: PRINCIPAL_INVESTIGATOR
References: