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Durham Connects RCT Evaluation

RCT Evaluation of the Durham Connects Universal Newborn Nurse Home Visiting Program

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01406184
Enrollment
2329
Registered
2011-08-01
Start date
2009-07-01
Completion date
2028-04-01
Last updated
2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Child Maltreatment, Confirmed, Unspecified Child Maltreatment, Suspected

Keywords

Child Abuse, Child Neglect, Child Hospital Emergency Room Presentations, Child Well-Care Compliance, Child Immunization Compliance

Brief summary

The aim of this randomized controlled trial (RCT) is to evaluate the impact and mechanisms of the Durham Connects (DC) brief universal nurse home-visiting program to prevent child maltreatment and improve child well-being. It is the first-ever RCT of a home-visiting program that is designed to prevent child maltreatment in an entire community population. Evaluation of program impact will test three hypotheses: 1) Random assignment to the Durham Connects Program will be associated with lower rates of child maltreatment and emergency department maltreatment-related injuries, better pediatric care, better parental functioning, and better child well-being than assignment as control; 2) Intervention effect sizes will be larger for higher-risk groups; and 3) Community resource use and enhanced family functioning will mediate the positive impact of Durham Connects on outcomes.

Detailed description

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 mother and child health and well-being. The Durham Connects Program is implemented jointly by the Durham County (North Carolina) Department of Public Health, the Center for Child & Family Health (a community non-profit), 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 July 1, 2009-December 31, 2010, all 4777 resident births from two Durham County hospitals (one academic tertiary care hospital and one community hospital) were randomized at the even-odd birth date group level, with families assigned to one of two intervention groups based on infant birth date: 1) even birth date families (n=2327) were randomly assigned to receive DC; DC staff attempted to schedule and visit all even birth date families; 2) odd birth date families (n=2450) were randomly assigned to receive other community services as usual and served as the 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. The Duke University Health System Institutional Review Board approved all RCT implementation and evaluation procedures. Completely independent of program implementation, a random, representative subsample of 549 families was selected to conduct an independent evaluation of DC beginning at infant age 6 months (initial interviews completed between infant ages 6-8 months). Use of random subsamples for evaluation of population-level interventions allows for testing of intervention impact while minimizing evaluation costs (e.g., Moving to Opportunity for Fair Housing intervention15). Consistent with this evaluation strategy, one family was randomly selected by computer algorithm from public birth records for each of the 549 days of the 18-month RCT enrollment period in order to examine program impact for families enrolled across the entire trial period. Families were selected from the entire population of eligible birth records (i.e., resident Durham County births at one of the two county birthing hospitals) without consideration for intervention participation or adherence. Selected families that declined participation were replaced with a randomly selected family with the same child birth date and race/ethnicity as the original family, in order to preserve any lack of selection bias based on these characteristics. Selected 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. Overall, 682 families were randomly selected and 549 (81%) participated (n=269 DC-eligible families; n=280 control families). Post-hoc comparisons of hospital discharge records and public birth records after all evaluation study consenting and interviews were complete identified 18 participating families that were subsequently declared ineligible due to hospital discharge record error (n=13 families with no hospital discharge record; n=3 families with child birth date discrepancies; and n=2 families with address discrepancies affecting Durham County residency), resulting in a final sample of 664 selected families and 531 participating families. The ineligible families (n=9 DC-eligible families; n=9 control families) were removed without consideration for intervention adherence or evaluation outcomes. \*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.

Interventions

The program consists of 4-7 intervention contacts, including 1) a hospital birthing visit when a staff member 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 connections to matched community resources, as needed, 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 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.

Sponsors

Duke University
Lead SponsorOTHER
The Duke Endowment
CollaboratorOTHER
The Pew Charitable Trusts
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Robert Wood Johnson Foundation
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No

Inclusion criteria

* Infant born between July 1, 2009 and December 31, 2010 * Infant born at Durham County, North Carolina (NC) hospital (Duke or Durham Regional) * Family of infant resides in Durham County, NC

Exclusion criteria

* Infant born before July 1, 2009 or after December 31, 2010 * Infant not born at Durham County, NC hospital * Family of infant resides outside of Durham County, NC

Design outcomes

Primary

MeasureTime frameDescription
DSS Investigated and Substantiated Child Maltreatment Rates0 - 12 Years of Child AgeNorth Carolina Department of Social Services (DSS) reported lifetime cases of investigated and substantiated maltreatment cases.

Secondary

MeasureTime frameDescription
Child Emergency Room (ER) Presentation Rates0 - 12 Years of Child AgeLifetime child emergency department visits reported in hospital administrative records
Child Overnight Stays in Hospital0 - 12 Years Months of Child AgeLifetime child overnight stays in hospital for all overnight stays unrelated to the birthing stay as reported in hospital administrative records.
Child Postnatal Well-Care Compliance Rates0 - 24 Months of Child AgeRates of child compliance with well-care pediatric visits as reported by the mother
Child Social-Emotional Competence and Behavior Problems24 - 66 Months of Child AgeMothers complete the Head Start Competence Scale (Domitrovich et al., 2001), measuring child social and emotional skills central to interpersonal relationships and emotion regulation. Mothers also complete the ages 1.5-5 version of the Child Behavior Checklist (CBCL 1.5-5; Achenbach \& Rescorla, 2001), a standardized measure assessing emotional and behavioral problems, including: 1) affective problems; 2) anxiety problems; 3) pervasive developmental problems; 4) Attention Deficit/Hyperactivity problems; and 5) Oppositional Defiant problems.
Mother Mental Health0-66 Months of Child AgeRates of mother depressive symptoms and anxiety symptoms as reported by the mother
Family Connections to Community Services/Resources0-66 Months of Child AgeRates of family connections to community resources and services as reported by the mother
Mother Parenting Behaviors0-66 Months of Child AgeRates of mother positive and negative parenting behaviors as reported by the mother or rated by an independent observer during in-home interviews or videotaped parent-child interactions

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKenneth Dodge, Ph.D.

Duke University

PRINCIPAL_INVESTIGATORRobert Murphy, Ph.D.

Center for Child & Family Health

PRINCIPAL_INVESTIGATORKaren O'Donnell, Ph.D.

Center for Child & Family Health

PRINCIPAL_INVESTIGATORW. Benjamin Goodman, Ph.D.

Duke University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026