NCT04438031

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
815

participants targeted

Target at P75+ for not_applicable

Timeline
51mo left

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Nov 2020Jun 2030

First Submitted

Initial submission to the registry

June 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

November 20, 2020

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

9.6 years

First QC Date

June 16, 2020

Last Update Submit

June 11, 2025

Conditions

Prenatal; Postnatal

Outcome Measures

Primary Outcomes (52)

  • Evaluate the implementation by the rate of enrollment in the Navigation program.

    Proportion of participants in the Navigation group who agree to schedule a prenatal Navigation visit, which will be collected from enrollment logs.

    Prenatally (up until delivery of target child)

  • Evaluate the implementation by the rate of retention in the Navigation program.

    This will be collected from participant tracking logs completed by the navigators (i.e., whether they completed the 12-month Navigation visit with the participant).

    12 months

  • Evaluate the implementation by the rate of retention in the Navigation program.

    This will be collected from participant tracking logs completed by the navigators (i.e., whether they completed the 24-month Navigation visit with the participant).

    24 months

  • Evaluate the implementation by the rate of retention in the Navigation program.

    This will be collected from participant tracking logs completed by the navigators (i.e., whether they completed the 36-month Navigation visit with the participant).

    36 months

  • Evaluate the implementation by the fidelity of implementation of the Navigation manual by Navigators.

    For 10% of the Navigation visits, a second Navigator will observe the primary Navigator. The second Navigator will check using a list of program elements from the program manual to assess whether the primary Navigator adheres to each program element. In addition, the second Navigator will score the family on each of the Navigation domains. Fidelity of implementation will be measure by the percent adherence to the program manual and the inter-rater reliability on the domain scores using Cohen's kappa statistic.

    12 months

  • Evaluate the implementation by the fidelity of implementation of the Navigation manual by Navigators.

    For 10% of the Navigation visits, a second Navigator will observe the primary Navigator. The second Navigator will check using a list of program elements from the program manual to assess whether the primary Navigator adheres to each program element. In addition, the second Navigator will score the family on each of the Navigation domains. Fidelity of implementation will be measure by the percent adherence to the program manual and the inter-rater reliability on the domain scores using Cohen's kappa statistic.

    24 months

  • Evaluate the implementation by the fidelity of implementation of the Navigation manual by Navigators.

    For 10% of the Navigation visits, a second Navigator will observe the primary Navigator. The second Navigator will check using a list of program elements from the program manual to assess whether the primary Navigator adheres to each program element. In addition, the second Navigator will score the family on each of the Navigation domains. Fidelity of implementation will be measure by the percent adherence to the program manual and the inter-rater reliability on the domain scores using Cohen's kappa statistic.

    36 months

  • Evaluate the implementation by the proportion of families receiving screening scores that indicate risk for negative child and/or family outcomes.

    This will be collected from case report forms completed by the Navigators. For each intervention domain of interest, Navigators will rate family needs on a 1-4 scale with scores of 3 and 4 indicating a need for referral to community resources. This outcome will be measured as the proportion of families receiving at least one score of 3 or 4.

    Prenatal (before delivery of target child)

  • Evaluate the implementation by the proportion of families receiving screening scores that indicate risk for negative child and/or family outcomes.

    This will be collected from case report forms completed by the Navigators. For each intervention domain of interest, Navigators will rate family needs on a 1-4 scale with scores of 3 and 4 indicating a need for referral to community resources. This outcome will be measured as the proportion of families receiving at least one score of 3 or 4.

    12 months

  • Evaluate the implementation by the proportion of families receiving screening scores that indicate risk for negative child and/or family outcomes.

    This will be collected from case report forms completed by the Navigators. For each intervention domain of interest, Navigators will rate family needs on a 1-4 scale with scores of 3 and 4 indicating a need for referral to community resources. This outcome will be measured as the proportion of families receiving at least one score of 3 or 4.

    24 months

  • Evaluate the implementation by the proportion of families receiving screening scores that indicate risk for negative child and/or family outcomes.

    This will be collected from case report forms completed by the Navigators. For each intervention domain of interest, Navigators will rate family needs on a 1-4 scale with scores of 3 and 4 indicating a need for referral to community resources. This outcome will be measured as the proportion of families receiving at least one score of 3 or 4.

    36 months

  • Evaluate the implementation by the proportion of families referred to community resources.

    This will be collected from case report forms completed by the Navigators. On the CRFs, Navigators will indicate any community resources to which they refer families. This outcome will be measured as the proportion of families that are referred to one or more community resources by the Navigator.

    Prenatally (before delivery of target child)

  • Evaluate the implementation by the proportion of families referred to community resources.

    This will be collected from case report forms completed by the Navigators. On the CRFs, Navigators will indicate any community resources to which they refer families. This outcome will be measured as the proportion of families that are referred to one or more community resources by the Navigator.

    12 months

  • Evaluate the implementation by the proportion of families referred to community resources.

    This will be collected from case report forms completed by the Navigators. On the CRFs, Navigators will indicate any community resources to which they refer families. This outcome will be measured as the proportion of families that are referred to one or more community resources by the Navigator.

    24 months

  • Evaluate the implementation by the proportion of families referred to community resources.

    This will be collected from case report forms completed by the Navigators. On the CRFs, Navigators will indicate any community resources to which they refer families. This outcome will be measured as the proportion of families that are referred to one or more community resources by the Navigator.

    36 months

  • Evaluate the implementation by the proportion of families that initiate community services.

    This will be collected from case report forms completed by the Navigators. On the CRFs, Navigators will indicate whether families initiated participation in the community services to which they were referred, if any. This outcome will be measured as the proportion of families referred to community services that initiate participation in at lease one community service.

    Prenatally (before delivery of target child)

  • Evaluate the implementation by the proportion of families that initiate community services.

    This will be collected from case report forms completed by the Navigators. On the CRFs, Navigators will indicate whether families initiated participation in the community services to which they were referred, if any. This outcome will be measured as the proportion of families referred to community services that initiate participation in at lease one community service.

    12 months

  • Evaluate the implementation by the proportion of families that initiate community services.

    This will be collected from case report forms completed by the Navigators. On the CRFs, Navigators will indicate whether families initiated participation in the community services to which they were referred, if any. This outcome will be measured as the proportion of families referred to community services that initiate participation in at lease one community service.

    24 months

  • Evaluate the implementation by the proportion of families that initiate community services.

    This will be collected from case report forms completed by the Navigators. On the CRFs, Navigators will indicate whether families initiated participation in the community services to which they were referred, if any. This outcome will be measured as the proportion of families referred to community services that initiate participation in at lease one community service.

    36 months

  • Evaluate the implementation by the families' satisfaction with the Navigation program.

    This will be measured via participant self-reports as the percentage of families that rate themselves as satisfied or very satisfied with their Navigation experience and the percentage of families that would recommend the program to other families.

    3 months

  • Evaluate the implementation by the families' satisfaction with the Navigation program.

    This will be measured via participant self-reports as the percentage of families that rate themselves as satisfied or very satisfied with their Navigation experience and the percentage of families that would recommend the program to other families.

    15 months

  • Evaluate the implementation by the families' satisfaction with the Navigation program.

    This will be measured via participant self-reports as the percentage of families that rate themselves as satisfied or very satisfied with their Navigation experience and the percentage of families that would recommend the program to other families.

    27 months

  • Evaluate the implementation by the families' satisfaction with the Navigation program.

    This will be measured via participant self-reports as the percentage of families that rate themselves as satisfied or very satisfied with their Navigation experience and the percentage of families that would recommend the program to other families.

    39 months

  • Evaluate the impact of the Navigation program by reviewing child maltreatment.

    This will be measured through Child Protective Services records via a comparison of the Navigation group and control group in their likelihood of having a substantiated or "services needed" case of maltreatment.

    12 months

  • Evaluate the impact of the Navigation program by reviewing child maltreatment.

    This will be measured through Child Protective Services records via a comparison of the Navigation group and control group in their likelihood of having a substantiated or "services needed" case of maltreatment.

    24 months

  • Evaluate the impact of the Navigation program by reviewing child maltreatment.

    This will be measured through Child Protective Services records via a comparison of the Navigation group and control group in their likelihood of having a substantiated or "services needed" case of maltreatment.

    36 months

  • Evaluate the impact of the Navigation program by reviewing child maltreatment.

    This will be measured through Child Protective Services records via a comparison of the Navigation group and control group in their likelihood of having a substantiated or "services needed" case of maltreatment.

    48 months

  • Evaluate the impact of the Navigation program by reviewing child maltreatment.

    This will be measured through Child Protective Services records via a comparison of the Navigation group and control group in their likelihood of having a substantiated or "services needed" case of maltreatment.

    60 months

  • Evaluate the impact of the Navigation program by reviewing maternal health.

    This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores of their ratings of their overall health, depression symptoms, anxiety symptoms, and substance abuse symptoms.

    3 months

  • Evaluate the impact of the Navigation program by reviewing maternal health.

    This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores of their ratings of their overall health, depression symptoms, anxiety symptoms, and substance abuse symptoms.

    15 months

  • Evaluate the impact of the Navigation program by reviewing maternal health.

    This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores of their ratings of their overall health, depression symptoms, anxiety symptoms, and substance abuse symptoms.

    27 months

  • Evaluate the impact of the Navigation program by reviewing maternal health.

    This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores of their ratings of their overall health, depression symptoms, anxiety symptoms, and substance abuse symptoms.

    39 months

  • Evaluate the impact of the Navigation program by reviewing maternal health.

    This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores of their ratings of their overall health, depression symptoms, anxiety symptoms, and substance abuse symptoms.

    51 months

  • Evaluate the impact of the Navigation program by reviewing maternal health.

    This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores of their ratings of their overall health, depression symptoms, anxiety symptoms, and substance abuse symptoms.

    63 months

  • Evaluate the impact of the Navigation program by reviewing child health and development.

    This will be measured from parent reports via a comparison of the Navigation and control groups' mean scores on ratings of their overall health, social-emotional development, and cognitive development.

    3 months

  • Evaluate the impact of the Navigation program by reviewing child health and development.

    This will be measured from parent reports via a comparison of the Navigation and control groups' mean scores on ratings of their overall health, social-emotional development, and cognitive development.

    15 months

  • Evaluate the impact of the Navigation program by reviewing child health and development.

    This will be measured from parent reports via a comparison of the Navigation and control groups' mean scores on ratings of their overall health, social-emotional development, and cognitive development.

    27 months

  • Evaluate the impact of the Navigation program by reviewing child health and development.

    This will be measured from parent reports via a comparison of the Navigation and control groups' mean scores on ratings of their overall health, social-emotional development, and cognitive development.

    39 months

  • Evaluate the impact of the Navigation program by reviewing child health and development.

    This will be measured from parent reports via a comparison of the Navigation and control groups' mean scores on ratings of their overall health, social-emotional development, and cognitive development.

    51 months

  • Evaluate the impact of the Navigation program by reviewing child health and development.

    This will be measured from parent reports via a comparison of the Navigation and control groups' mean scores on ratings of their overall health, social-emotional development, and cognitive development.

    63 months

  • Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.

    This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores on ratings of their knowledge of child development, parenting self-efficacy, parenting stress, parent discipline behavior, and parent attributions of child behavior.

    3 months

  • Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.

    This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores on ratings of their knowledge of child development, parenting self-efficacy, parenting stress, parent discipline behavior, and parent attributions of child behavior.

    15 months

  • Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.

    This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores on ratings of their knowledge of child development, parenting self-efficacy, parenting stress, parent discipline behavior, and parent attributions of child behavior.

    27 months

  • Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.

    This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores on ratings of their knowledge of child development, parenting self-efficacy, parenting stress, parent discipline behavior, and parent attributions of child behavior.

    39 months

  • Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.

    This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores on ratings of their knowledge of child development, parenting self-efficacy, parenting stress, parent discipline behavior, and parent attributions of child behavior.

    51 months

  • Evaluate the impact of the Navigation program by reviewing parent and parent-child relationships.

    This will be measured from participant self-reports via a comparison of Navigation and control groups' mean scores on ratings of their knowledge of child development, parenting self-efficacy, parenting stress, parent discipline behavior, and parent attributions of child behavior.

    63 months

  • Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.

    Family services receipt will be measured from parent reports via a comparison of the Navigation and control groups' mean number of community services they have accessed since receiving Navigation/the control intervention. Connection to a medical home will be measured from parent report via a comparison of the Navigation and control groups' likelihood of having a primary care physician for their child.

    3 months

  • Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.

    Family services receipt will be measured from parent reports via a comparison of the Navigation and control groups' mean number of community services they have accessed since receiving Navigation/the control intervention. Connection to a medical home will be measured from parent report via a comparison of the Navigation and control groups' likelihood of having a primary care physician for their child.

    15 months

  • Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.

    Family services receipt will be measured from parent reports via a comparison of the Navigation and control groups' mean number of community services they have accessed since receiving Navigation/the control intervention. Connection to a medical home will be measured from parent report via a comparison of the Navigation and control groups' likelihood of having a primary care physician for their child.

    27 months

  • Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.

    Family services receipt will be measured from parent reports via a comparison of the Navigation and control groups' mean number of community services they have accessed since receiving Navigation/the control intervention. Connection to a medical home will be measured from parent report via a comparison of the Navigation and control groups' likelihood of having a primary care physician for their child.

    39 months

  • Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.

    Family services receipt will be measured from parent reports via a comparison of the Navigation and control groups' mean number of community services they have accessed since receiving Navigation/the control intervention. Connection to a medical home will be measured from parent report via a comparison of the Navigation and control groups' likelihood of having a primary care physician for their child.

    51 months

  • Evaluate the impact of the Navigation program by reviewing family service receipt and children's connection to medical home.

    Family services receipt will be measured from parent reports via a comparison of the Navigation and control groups' mean number of community services they have accessed since receiving Navigation/the control intervention. Connection to a medical home will be measured from parent report via a comparison of the Navigation and control groups' likelihood of having a primary care physician for their child.

    63 months

Study Arms (3)

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

EXPERIMENTAL

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.

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

Control Intervention

OTHER

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

Behavioral: Control Intervention

Navigation Intervention Prenatal 2.0

EXPERIMENTAL

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.

Behavioral: Navigation Intervention Prenatal 2.0

Interventions

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

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.

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

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

Control Intervention
Navigation Intervention Prenatal 2.0BEHAVIORAL

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.

Navigation Intervention Prenatal 2.0

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University

Durham, North Carolina, 27708, United States

Location

Study Officials

  • Kenneth Dodge, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 18, 2020

Study Start

November 20, 2020

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Last Updated

June 13, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)