Durham Connects RCT Evaluation
NCT01406184 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2329
Last updated 2025-06-15
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.
Conditions
- Unspecified Child Maltreatment, Suspected
- Unspecified Child Maltreatment, Confirmed
Interventions
- OTHER
-
Durham Connects
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 & Collaborators
-
The Duke Endowment
collaborator OTHER -
The Pew Charitable Trusts
collaborator OTHER -
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH -
Robert Wood Johnson Foundation
collaborator OTHER - lead OTHER
Principal Investigators
-
Kenneth Dodge, Ph.D. · Duke University
-
Robert Murphy, Ph.D. · Center for Child & Family Health
-
Karen O'Donnell, Ph.D. · Center for Child & Family Health
-
W. Benjamin Goodman, Ph.D. · Duke University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Max Age
- 6 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-07-31
- Primary Completion
- 2024-12-31
- Completion
- 2027-04-30
Countries
- United States
Study Locations
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