NCT01843036

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,650

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jan 2014Jun 2028

First Submitted

Initial submission to the registry

April 26, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
14.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

14.4 years

First QC Date

April 26, 2013

Last Update Submit

May 4, 2026

Conditions

Unspecified Child Maltreatment, SuspectedUnspecified Child Maltreatment, Confirmed

Keywords

Child AbuseChild NeglectChild Emergency Medical Care PresentationsChild Well-Care ComplianceMother Well-Care ComplianceMother Emergency Medical Care PresentationsMother Mental HealthFamily Connections to Community ResourcesParent-Child Relationship Quality

Outcome Measures

Primary Outcomes (1)

  • DSS Investigated and Substantiated Child Maltreatment Rates

    North Carolina Department of Social Services (DSS) reported lifetime cases of investigated and substantiated maltreatment caseness

    0 - 12 Years of Child Age

Secondary Outcomes (9)

  • Child Emergency Room (ER) Presentation Rates

    0 - 12 Years of Child Age

  • Child Overnight Stays in Hospital

    0 - 12 Years of Child Age

  • Mother Postnatal Well-Care Compliance Rates

    0-6 Months Postnatal

  • Child Postnatal Well-Care Compliance Rates

    0-6 Months Postnatal

  • Mother Emergency Room (ER) Presentation Rates

    0 - 12 Years of Child Age

  • +4 more secondary outcomes

Study Arms (2)

Durham Connects Eligible

EXPERIMENTAL

From January 1, 2014 - June 30, 2014, all odd-birth-date residential births in Durham County, North Carolina will be randomly assigned to receive the Durham Connects nurse home visiting program.

Other: Durham Connects

Control

NO INTERVENTION

From January 1, 2014 - June 30, 2014, all even-birth-date residential births in Durham County, North Carolina will be randomly assigned to a control group condition. These families will be assigned to receive services as usual and serve as the randomized comparison group for evaluating Durham Connects program impact.

Interventions

Durham ConnectsOTHER

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).

Durham Connects Eligible

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Child and Family Policy, Duke University

Durham, North Carolina, 27708, United States

Location

Related Publications (2)

  • Dodge KA, Goodman WB, Bai Y, Best DL, Rehder P, Hill S. Impact of a universal perinatal home-visiting program on reduction in race disparities in maternal and child health: Two randomised controlled trials and a field quasi-experiment. Lancet Reg Health Am. 2022 Aug 23;15:100356. doi: 10.1016/j.lana.2022.100356. eCollection 2022 Nov.

    PMID: 36778074BACKGROUND

  • Dodge KA, Goodman WB, Bai Y, O'Donnell K, Murphy RA. Effect of a Community Agency-Administered Nurse Home Visitation Program on Program Use and Maternal and Infant Health Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Nov 1;2(11):e1914522. doi: 10.1001/jamanetworkopen.2019.14522.

    PMID: 31675088RESULT

Related Links

Study Officials

  • Kenneth A Dodge, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

  • Robert Murphy, Ph.D.

    Center for Child & Family Health

    PRINCIPAL INVESTIGATOR

  • Karen O'Donnell, Ph.D.

    Center for Child & Family Health

    PRINCIPAL INVESTIGATOR

  • W. Benjamin Goodman, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2013

First Posted

April 30, 2013

Study Start

January 1, 2014

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)