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NCT Number: NCT04438031

Navigation Study: Durham

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prenatal; Postnatal

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27708, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Control Intervention

Behavioral

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

Navigation Intervention Prenatal 2.0

Behavioral

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.

Primary outcomes

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

    Time frame: Prenatally (up until delivery of target child)

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

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

    Time frame: 12 months

    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).

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

    Time frame: 24 months

    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).

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

    Time frame: 36 months

    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).

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

    Time frame: 12 months

    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.

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

    Time frame: 24 months

    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.

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

    Time frame: 36 months

    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.

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

    Time frame: Prenatal (before delivery of target child)

    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.

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

    Time frame: 12 months

    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.

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

    Time frame: 24 months

    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.

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

    Time frame: 36 months

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

    Time frame: Prenatally (before delivery of target child)

    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.

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

    Time frame: 12 months

    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.

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

    Time frame: 24 months

    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.

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

    Time frame: 36 months

    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.

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

    Time frame: Prenatally (before delivery of target child)

    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.

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

    Time frame: 12 months

    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.

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

    Time frame: 24 months

    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.

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

    Time frame: 36 months

    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.

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

    Time frame: 3 months

    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.

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

    Time frame: 15 months

    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.

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

    Time frame: 27 months

    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.

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

    Time frame: 39 months

    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.

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

    Time frame: 12 months

    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.

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

    Time frame: 24 months

    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.

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

    Time frame: 36 months

    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.

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

    Time frame: 48 months

    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.

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

    Time frame: 60 months

    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.

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

    Time frame: 3 months

    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.

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

    Time frame: 15 months

    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.

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

    Time frame: 27 months

    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.

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

    Time frame: 39 months

    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.

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

    Time frame: 51 months

    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.

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

    Time frame: 63 months

    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.

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

    Time frame: 3 months

    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.

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

    Time frame: 15 months

    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.

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

    Time frame: 27 months

    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.

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

    Time frame: 39 months

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

    Time frame: 51 months

    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.

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

    Time frame: 63 months

    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.

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

    Time frame: 3 months

    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.

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

    Time frame: 15 months

    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.

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

    Time frame: 27 months

    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.

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

    Time frame: 39 months

    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.

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

    Time frame: 51 months

    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.

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

    Time frame: 63 months

    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.

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

    Time frame: 3 months

    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.

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

    Time frame: 15 months

    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.

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

    Time frame: 27 months

    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.

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

    Time frame: 39 months

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

    Time frame: 51 months

    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.

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

    Time frame: 63 months

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Evaluation of the Navigation Prevention Program: Durham

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Jun 18, 2020
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.