RCT Evaluation of the Durham Connects Universal Newborn Nurse Home Visiting Program
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 2,329
- 试验地点
- 2
- 主要终点
- DSS Investigated and Substantiated Child Maltreatment Rates
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Durham Connects Eligible Group
From July 1, 2009 - December 31, 2010, all even-birth-date residential births in Durham County, North Carolina were randomly assigned to receive the Durham Connects nurse home visiting program.
干预措施: Durham Connects (Other)
Control Group
From July 1, 2009 - December 31, 2010, all odd-birth-date residential births in Durham County, North Carolina were randomly assigned to a control group condition. These families were assigned to receive services as usual and served as the randomized comparison group for evaluating Durham Connects program impact.
结局指标
主要结局
DSS Investigated and Substantiated Child Maltreatment Rates
时间窗: 0 - 12 Years of Child Age
North Carolina Department of Social Services (DSS) reported lifetime cases of investigated and substantiated maltreatment cases.
次要结局
- Child Emergency Room (ER) Presentation Rates(0 - 12 Years of Child Age)
- Child Postnatal Well-Care Compliance Rates(0 - 24 Months of Child Age)
- Mother Mental Health(0-66 Months of Child Age)
- Child Overnight Stays in Hospital(0 - 12 Years Months of Child Age)
- Child Social-Emotional Competence and Behavior Problems(24 - 66 Months of Child Age)
- Family Connections to Community Services/Resources(0-66 Months of Child Age)
- Mother Parenting Behaviors(0-66 Months of Child Age)
