Durham Connects RCT Evaluation II

NCT01843036 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1650

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Unspecified Child Maltreatment, Suspected
  • Unspecified Child Maltreatment, Confirmed

Interventions

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 areas of family functioning across 4 domains (i.e. - healthcare, parenting/childcare, family violence/safety, and maternal well-being). For each domain found to be at risk, the nurse intervenes directly to support the mother (mild risk) or connects the mother with matched community resources as needed to address individualized long-term family needs (moderate or severe risk).

Sponsors & Collaborators

  • The Duke Endowment

    collaborator OTHER
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • Coalition for Evidence-Based Policy

    collaborator UNKNOWN
  • Laura and John Arnold Foundation

    collaborator OTHER
  • Duke University

    lead OTHER

Principal Investigators

  • Kenneth A 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
2014-01-31
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01843036 on ClinicalTrials.gov