Durham Connects Evaluation
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First Received Date ICMJE | July 28, 2011 | ||||||||||||||||
Last Updated Date | July 18, 2012 | ||||||||||||||||
Start Date ICMJE | July 2009 | ||||||||||||||||
Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
DSS Investigated and Substantiated Child Maltreatment Rates [ Time Frame: 0 - 66 months of child age ] [ Designated as safety issue: Yes ] North Carolina Department of Social Services (DSS) reported lifetime caseness of investigated and substantiated maltreatment caseness |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Change History | Complete list of historical versions of study NCT01406184 on ClinicalTrials.gov Archive Site | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
Current Other Outcome Measures ICMJE | |||||||||||||||||
Original Other Outcome Measures ICMJE | |||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | Durham Connects Evaluation | ||||||||||||||||
Official Title ICMJE | Evaluation of the Durham Connects Nurse Home Visiting Program | ||||||||||||||||
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. |
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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 well-being. The Durham Connects Program is implemented jointly by the Durham County (North Carolina) Department of 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. From July 1, 2009, through December 31, 2010, all 4,782 residential births in Durham County, North Carolina, were randomly assigned according to birthdate, with even-birth-dates assigned to receive DC. Odd-birth-dates were assigned to receive services-as-usual and served as the control group. Program implementation was evaluated for all 2,330 even-birth-date families. Durham Connects begins with a visit during the birthing hospital stay, followed by 1-3 nurse home visits between 4-12 weeks of infant age, and then a follow-up contact one month later. During the visits, the nurse engages with the mother and completes a health and psychosocial assessment, during which she systematically assesses risk and family needs in 12 important empirically-derived domains of family functioning. For each domain found to be at risk, the nurse intervenes directly to support the mother or connects the mother with ongoing evidence-based interventions in the community. Although Durham Connects is implemented universally, it focuses on triaging families according to assessed risk and then connecting them with ongoing collaborating community resources that can "carry the family's baton" after the nurse home-visitor leaves the family. |
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Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase | |||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Other: Durham Connects
Durham Connects begins with a visit during the birthing hospital stay, followed by 1-3 nurse home visits between 4-12 weeks of infant age, and then a follow-up contact one month later. During the visits, the nurse engages with the mother and completes a health and psychosocial assessment, during which she systematically assesses risk and family needs in 12 important empirically-derived domains of family functioning. For each domain found to be at risk, the nurse intervenes directly to support the mother or connects the mother with ongoing evidence-based interventions in the community |
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Study Arm (s) |
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Publications * | |||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||||||
Enrollment ICMJE | 2329 | ||||||||||||||||
Estimated Completion Date | June 2016 | ||||||||||||||||
Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||||||
Ages | up to 6 Months | ||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Location Countries ICMJE | United States | ||||||||||||||||
Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT01406184 | ||||||||||||||||
Other Study ID Numbers ICMJE | Pro00017478, Pro00020974 | ||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||
Responsible Party | Duke University | ||||||||||||||||
Study Sponsor ICMJE | Duke University | ||||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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Information Provided By | Duke University | ||||||||||||||||
Verification Date | June 2012 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |