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NCT01843036
Durham Connects RCT Evaluation II
Conditions: Unspecified Child Maltreatment, Suspected, Unspecified Child Maltreatment, Confirmed
Sex: All
Ages: N/A – 6 Months
Healthy volunteers: No
Phase: NA
Enrollment: 1650
Sponsor: Duke University
Location: Center for Child and Family Policy, Duke University Durham North Carolina
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.
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
Source: ClinicalTrials.gov (NCT01843036). StuddyBuddy aggregates publicly available trial information.