An interventional study of Navigation Intervention Version 1.0 (discontinued, modified to Version 2.0. Data will not be used) and Control Intervention in Prenatal; Postnatal, sponsored by Duke University. Active, not recruiting at 1 site in United States. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Duke University · Not applicable, Interventional, and Health services research
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.
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.
Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Navigation Intervention Version 1.0 (discontinued, modified to Version 2.0. Data will not be used)
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.
Behavioral: Control Intervention
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.
Behavioral: Navigation Intervention Version 2.0
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.
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 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.
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 66 months
Plan to share: No
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Duke University