Navigation Study: Durham
August 19, 2026 updated by: Duke University
Evaluation of the Navigation Prevention Program: Durham
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.
Study Overview
Status
Active, not recruiting
Conditions
Detailed Description
Note: 400 families were enrolled in this RCT under Navigation 1.0.
However, their data will not be included in any analysis due to changes to the Navigation intervention design resulting in Navigation 2.0.
The final RCT sample includes of 815 participants enrolled during the implementation of Navigation 2.0.
Study Type
Interventional
Enrollment (Actual)
815
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27708
- Duke University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Pregnant individuals residing in Durham County, NC who are receiving prenatal care from a Duke University OB/GYN clinic, the Durham County Health Department, or the local Fetal Diagnostic Center.
- Primary language is English or Spanish
- Recruited into the study at or before 28 weeks gestation.
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Navigation 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.
|
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.
|
|
Other: 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.
|
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.
|
|
Experimental: 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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 months
|
|
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.
|
3 months
|
|
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.
|
3 months
|
|
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.
|
3 months
|
|
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.
|
3 months
|
|
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.
|
Prenatally (up until delivery of target child)
|
|
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).
|
12 months
|
|
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).
|
24 months
|
|
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).
|
36 months
|
|
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.
|
12 months
|
|
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.
|
24 months
|
|
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.
|
36 months
|
|
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.
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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.
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.
|
12 months
|
|
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.
|
24 months
|
|
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.
|
36 months
|
|
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.
|
Prenatally (before delivery of target child)
|
|
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.
|
12 months
|
|
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.
|
24 months
|
|
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.
|
36 months
|
|
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.
|
Prenatally (before delivery of target child)
|
|
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.
|
12 months
|
|
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.
|
24 months
|
|
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.
|
36 months
|
|
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.
|
15 months
|
|
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.
|
27 months
|
|
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.
|
39 months
|
|
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.
|
12 months
|
|
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.
|
24 months
|
|
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.
|
36 months
|
|
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.
|
48 months
|
|
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.
|
60 months
|
|
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.
|
15 months
|
|
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.
|
27 months
|
|
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.
|
39 months
|
|
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.
|
51 months
|
|
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.
|
63 months
|
|
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.
|
15 months
|
|
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.
|
27 months
|
|
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 months
|
|
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.
|
51 months
|
|
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.
|
63 months
|
|
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.
|
15 months
|
|
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.
|
27 months
|
|
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.
|
39 months
|
|
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.
|
51 months
|
|
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.
|
63 months
|
|
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.
|
15 months
|
|
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.
|
27 months
|
|
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.
|
39 months
|
|
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.
|
51 months
|
|
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.
|
63 months
|
|
Evaluate the impact of the Navigation program by assessing child kindergarten readiness
Time Frame: 66 months
|
This will be measured from North Carolina Department of Public Instruction administrative records via a comparison of Navigation and control groups' mean child achievement scores child reading and math, as well as behavior and discipline records.
|
66 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kenneth Dodge, PhD, Duke University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2020
Primary Completion (Estimated)
June 30, 2030
Study Completion (Estimated)
June 30, 2030
Study Registration Dates
First Submitted
June 16, 2020
First Submitted That Met QC Criteria
June 16, 2020
First Posted (Actual)
June 18, 2020
Study Record Updates
Last Update Posted (Actual)
August 21, 2026
Last Update Submitted That Met QC Criteria
August 19, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- Pro00104042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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