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Durham Connects Universal Newborn Nurse Home Visiting Program for Child and Family Well-being

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Study Aim

This study aims to prevent child maltreatment by evaluating the effectiveness of the Durham Connects Universal Newborn Nurse Home Visiting Program on reducing North Carolina Department of Social Services reported cases of investigated and substantiated maltreatment.

What is being tested

Durham Connects: Postnatal Support

Other
Who is being recruted

Until 6 Months
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: January 2014
See protocol details

Summary

Principal SponsorDuke University
Last updated: August 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2014

Actual date on which the first participant was enrolled.

The Durham Connects program is an innovative, community-based, universal nurse home-visiting program that aims to lower the population rate of child maltreatment and improve child and family health and well-being. The Durham Connects Program is implemented jointly by the Durham County (North Carolina) Health Department, the Center for Child \& Family Health, and Duke University. It is designed to be brief and inexpensive per family so that communities can afford its costs. Its goals are consistent with those of more intensive nurse home-visiting programs: 1) to connect with the mother in order to enhance maternal skills and self-efficacy; and 2) to connect the mother with needed community services such as health care, child care, mental health care, and financial and social support; so that 3) the mother can connect with her child. DC achieves population reach by engaging all families within the community, rapidly triaging families based on identified risk to concentrate resources to families with greater needs, and connecting those families with significant nurse-identified risk to matched community programs and services to provide long-term support and a first step into the community system of care. The program consists of 4-7 manualized intervention contacts, including 1) a hospital birthing visit when a staff member communicates the importance of community support for parenting and schedules an initial home visit; 2) 1-3 nurse home visits between 3-12 weeks of infant age to provide physical assessments for infant and mother, intervention and education, assessment of family-specific needs, and for families with significant nurse-identified risk, connections to matched community resources to provide longer-term support; 3) 1-2 nurse contacts with community service providers to facilitate successful connections; and 4) a telephone follow-up one month after case closure to review consumer satisfaction and community connection outcomes. With family consent, letters from the program reporting on the visit are also provided to also connect families to maternal and infant healthcare providers for ongoing support. During home visits, the nurse engages the mother (and father, when possible) to provide brief educational interventions for all families (e.g., safe sleep) and utilizes a high-inference approach to assess family needs across 12 empirically-derived factors linked to child health and well-being: Healthcare: parent health, infant health, health care plans; Parenting/childcare: childcare plans, parent-infant relationship, management of infant crying; Family violence/safety: material supports, family violence, maltreatment history; and Parent well-being: depression/anxiety, substance abuse, social/emotional support. The nurse scores each of the 12 factors and intervenes accordingly. A score of 1 (low risk) receives no subsequent intervention. A score of 2 (moderate risk) receives short-term, nurse-delivered intervention over 1-2 sessions. For a score of 3 (high risk) the nurse connects the family to matched community resources tailored to address that particular risk (such as, treatment for postpartum depression, a DSS social worker exclusively serving Durham Connects families for enrollment in Medicaid or food stamps, a multi-year home visiting program for long-term parent support). The nurse also provides follow up to make sure that each connection "sticks," requiring additional contacts with the family or community agency. A score of 4 (imminent risk) receives emergency intervention (<1% of cases). A final contact four weeks after case closure ascertains community connection outcomes and whether further problem solving is needed to address new or existing needs. From January 1, 2014, through June 30, 2014, all residential births in Durham County, North Carolina (\~1600) will randomly assigned according to birthdate, with odd-birth-dates assigned to receive DC. Even-birth-dates will be assigned to receive services-as-usual and serve as the randomized control group. All eligible families (i.e., families living in Durham County giving birth at one of the two county hospitals) were included with experimental rigor, and without exception, but with ethical care for confidentiality. Hospital discharge records were utilized to confirm eligibility for all RCT families. Program implementation will be evaluated for all odd-birth-date families. The Duke University Health System Institutional Review Board approved all RCT implementation and evaluation procedures. Completely independent of program implementation, all RCT families were contacted and invited to participate in an independent evaluation of DC short-term impact at infant age 6 months (interviews completed between infant ages 6-8 months). Eligible RCT families were identified using short-form public birth records (i.e., resident Durham County births at one of the two county birthing hospitals) without consideration for intervention participation or adherence. RCT families were contacted and invited to participate in a descriptive research study about family community service use and child development. Families were blind to study goals, and home interviewers were blind to family DC participation status. \*Note - Although all study data collection timepoints are complete, the North Carolina Department of Health and Human Services (NC DHHS) is currently refusing to release final maltreatment records to study investigators. The Study Completion Date has been updated to reflect the additional time needed for Duke University and the investigators to negotiate the release of these records. The delay is unrelated to this study or its investigator team. Rather, the delay is due to discrepancies in data network security standards between NC DHHS and Duke University.

NCT01843036
Principal SponsorDuke University
Last updated: August 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1650 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 6 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
Family of infant resides in Durham County, NC

Infant born at a Durham County, North Carolina (NC) hospital (Duke or Durham Regional)

Infant born between January 1, 2014 and June 30, 2014

3 exclusion criteria prevent from participating
Family of infant resides outside of Durham County, NC

Infant born before January 1, 2014 or after June 30, 2014

Infant not born at a Durham County, NC hospital (Duke or Durham Regional)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Newborns with odd birth dates in Durham County, NC from Jan 1, 2014 - Jun 30, 2014 are randomly chosen for Durham Connects nurse home visits. These visits happen between 4-12 weeks of infant age.

Group II

No Intervention
Families in this group receive standard services available in their area. They serve as a comparison to help evaluate the impact of the Durham Connects program.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Center for Child and Family Policy, Duke University

Durham, United StatesOpen Center for Child and Family Policy, Duke University in Google Maps
SuspendedOne Study Center