Clinical trial NCT01843036: Durham Connects RCT Evaluation II
Official title: Second RCT Evaluation of the Durham Connects Universal Newborn Nurse Home Visiting Program
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Unspecified Child Maltreatment, Suspected
Unspecified Child Maltreatment, Confirmed
Keywords: Child Abuse
Child Neglect
Child Emergency Medical Care Presentations
Child Well-Care Compliance
Mother Well-Care Compliance
Mother Emergency Medical Care Presentations
Mother Mental Health
Family Connections to Community Resources
Parent-Child Relationship Quality
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: The Duke Endowment
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Coalition for Evidence-Based Policy
name: Laura and John Arnold Foundation
First posted: 2013-04-30
Enrollment: 1650
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this randomized controlled trial (RCT) is to conduct a second, independent evaluation the implementation and impact of the Durham Connects (DC) brief universal nurse home-visiting program to prevent child maltreatment and improve child and family health and well-being. Durham Connects is the first home-visiting program that is designed to prevent child maltreatment and improve health and well-being outcomes in an entire community population.

Program evaluation will test four hypotheses: 1) The program can be implemented with population reach, fidelity to the manualized intervention protocol, and reliability in assessment of family risk; 2) 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 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.

Eligibility criteria: Inclusion Criteria:

* Infant born between January 1, 2014 and June 30, 2014
* Infant born at a Durham County, North Carolina (NC) hospital (Duke or Durham Regional)
* Family of infant resides in Durham County, NC

Exclusion Criteria:

* Infant born before January 1, 2014 or after June 30, 2014
* Infant not born at a Durham County, NC hospital (Duke or Durham Regional)
* Family of infant resides outside of Durham County, NC

Primary outcomes:
measure: DSS Investigated and Substantiated Child Maltreatment Rates
timeFrame: 0 - 12 Years of Child Age
Secondary outcomes:
measure: Child Emergency Room (ER) Presentation Rates
timeFrame: 0 - 12 Years of Child Age
measure: Child Overnight Stays in Hospital
timeFrame: 0 - 12 Years of Child Age
measure: Mother Postnatal Well-Care Compliance Rates
timeFrame: 0-6 Months Postnatal
measure: Child Postnatal Well-Care Compliance Rates
timeFrame: 0-6 Months Postnatal
measure: Mother Emergency Room (ER) Presentation Rates
timeFrame: 0 - 12 Years of Child Age
measure: Mother Overnight Stays in Hospital
timeFrame: 0 - 12 Years of Child Age
measure: Mother Mental Health
timeFrame: 0-6 Months Postnatal
measure: Family Connections to Community Services/Resources
timeFrame: 0-6 Months Postnatal
measure: Mother Parenting Behaviors
timeFrame: 0-6 Months Postnatal
Other outcomes:
Locations:
city: Durham
country: United States
facility: Center for Child and Family Policy, Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Kenneth A Dodge, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Child & Family Health
name: Robert Murphy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Child & Family Health
name: Karen O'Donnell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: W. Benjamin Goodman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dodge KA, Goodman WB, Bai Y, Best DL, Rehder P, Hill S. Impact of a universal perinatal home-visiting program on reduction in race disparities in maternal and child health: Two randomised controlled trials and a field quasi-experiment. Lancet Reg Health Am. 2022 Aug 23;15:100356. doi: 10.1016/j.lana.2022.100356. eCollection 2022 Nov.
citation: Dodge KA, Goodman WB, Bai Y, O'Donnell K, Murphy RA. Effect of a Community Agency-Administered Nurse Home Visitation Program on Program Use and Maternal and Infant Health Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Nov 1;2(11):e1914522. doi: 10.1001/jamanetworkopen.2019.14522.