Prenatal; PostnatalNCT04438031
Navigation Study: Durham
A study testing Navigation Intervention Version 1.0 (discontinued, modified to Version 2.0. Data will not be used) and Navigation Intervention Version 2.0 in people with Prenatal; Postnatal, run by Duke University at 1 site in United States.
Trial summary
The purpose of this RCT is to evaluate the implementation and impact of a new, community-wide prevention program, "Community Navigation", on maternal and child health and well-being. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Prenatal; Postnatal
- What is being tested?
- Navigation Intervention Version 1.0 (discontinued, modified to Version 2.0. Data will not be used) and Navigation Intervention Version 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 815 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prenatal; Postnatal
- Being tested
- Navigation Intervention Version 1.0 (discontinued, modified to Version 2.0. Data will not be used), Control Intervention, Navigation Intervention Version 2.0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigation Intervention Version 1.0 (discontinued, modified to Version 2.0. Data will not be used)Behavioural
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.
Control InterventionBehavioural
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.
Navigation Intervention Version 2.0Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Navigation Version 1.0 (discontinued, modified to Version 2.0. Data will not be used) | Experimental | 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. Receives: Behavioral: Navigation Intervention Version 1.0 (discontinued, modified to Version 2.0. Data will not be used) |
| Control Intervention | Other | 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. Receives: Behavioral: Control Intervention |
| Navigation Intervention Version 2.0 | Experimental | 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. Receives: Behavioral: Navigation Intervention Version 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 63 months
Evaluate the impact of the Navigation program by assessing child kindergarten readiness
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.
Measured: 66 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start20 Nov 2020
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prenatal; PostnatalStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 815 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Dodge, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438031
- Sponsor's protocol ID
- Pro00104042
- Status last verified
- Aug 2026
- First submitted
- 16 Jun 2020
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Milojevich HM, Best DL, Goodman WB, Rehder PD, Dodge KA. Community Navigation: Iterative Development and Implementation of a Prenatal Psychosocial System of Care. Prev Sci. 2026 Aug;27(6):971-982. doi: 10.1007/s11121-026-01939-7. Epub 2026 Jun 25.
PubMed 42350752
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Navigation Prevention Program: Durham
- ClinicalTrials.gov ID
- NCT04438031
- Acronym / sponsor ID
- Pro00104042
- Conditions
- Prenatal; Postnatal
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 815 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Navigation Version 1.0 (discontinued, modified to Version 2.0. Data will not be used) | Experimental | Behavioral: Navigation Intervention Version 1.0 (discontinued, modified to Version 2.0. Data will not be used)Navigation 1.0 recruits mothers in OB/GYN (prenatal) offices, provides up to three Navigation visits, establishes connections between the family and primary health care or other community providers, and then follows up one month later to confirm these referrals. Navigators will assess and support family needs across multiple developmentally-appropriate domains at each age. Prenatally, the domains include support for (1) health and access to healthcare, (2) adjustments to pregnancy, (3) household and material needs, and (4) family safety. At 12, 24, and 36 months, the domains include support for (1) child basic needs, (2) parenting and child behavior, (3) child health and development, and (4) parent health and well-being. |
| Control Intervention | Other | Behavioral: Control InterventionBrief 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. |
| Navigation Intervention Version 2.0 | Experimental | Behavioral: Navigation Intervention Version 2.0Navigation 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. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigation Intervention Version 1.0 (discontinued, modified to Version 2.0. Data will not be used)Navigation 1.0 recruits mothers in OB/GYN (prenatal) offices, provides up to three Navigation visits, establishes connections between the family and primary health care or other community providers, and then follows up one month later to confirm these referrals. Navigators will assess and support family needs across multiple developmentally-appropriate domains at each age. Prenatally, the domains include support for (1) health and access to healthcare, (2) adjustments to pregnancy, (3) household and material needs, and (4) family safety. At 12, 24, and 36 months, the domains include support for (1) child basic needs, (2) parenting and child behavior, (3) child health and development, and (4) parent health and well-being. | Behavioural | Navigation Version 1.0 (discontinued, modified to Version 2.0. Data will not be used) |
| Control InterventionBrief 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. | Behavioural | Control Intervention |
| Navigation Intervention Version 2.0Navigation 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. | Behavioural | Navigation Intervention Version 2.0 |
Primary outcome
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.
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Results publication: PubMed 42350752Milojevich HM, Best DL, Goodman WB, Rehder PD, Dodge KA. Community Navigation: Iterative Development and Implementation of a Prenatal Psychosocial System of Care. Prev Sci. 2026 Aug;27(6):971-982. doi: 10.1007/s11121-026-01939-7. Epub 2026 Jun 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Dodge, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation Intervention Version 1.0 (discontinued, modified to Version 2.0. Data will not be used) and Navigation Intervention Version 2.0 in people with Prenatal; Postnatal, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the implementation by the rate of enrollment in the Navigation program. (time frame: Prenatally (up until delivery of target child)). The study lists 53 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04438031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.