Durham Connects RCT Evaluation

NCT01406184 | Active Not Recruiting DMC

• 4 other identifiers: Pro00020974Pro000174781R01HD069981Pro00027652
• Study Type: interventional
• Target: 2,329
• Locations: 1 country
• Sites: 1

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.

Conditions

Unspecified Child Maltreatment, Suspected; Unspecified Child Maltreatment, Confirmed

Keywords

Child Abuse; Child Neglect; Child Hospital Emergency Room Presentations; Child Well-Care Compliance; Child Immunization Compliance

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 (7)

• Child Emergency Room (ER) Presentation Rates

  0 - 12 Years of Child Age

• Child Overnight Stays in Hospital

  0 - 12 Years Months of Child Age

• Child Postnatal Well-Care Compliance Rates

  0 - 24 Months of Child Age

• Child Social-Emotional Competence and Behavior Problems

  24 - 66 Months of Child Age

• Mother Mental Health

  0-66 Months of Child Age

Study Arms (2)

Durham Connects Eligible Group

EXPERIMENTAL

From July 1, 2009 - December 31, 2010, all even-birth-date residential births in Durham County, North Carolina were randomly assigned to receive the Durham Connects nurse home visiting program.

Other: Durham Connects

Control Group

NO INTERVENTION

From July 1, 2009 - December 31, 2010, all odd-birth-date residential births in Durham County, North Carolina were randomly assigned to a control group condition. These families were assigned to receive services as usual and served as the randomized comparison group for evaluating Durham Connects program impact.

Interventions

Durham Connects OTHER

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.

Durham Connects Eligible Group

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infant born between July 1, 2009 and December 31, 2010
• Infant born at 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 July 1, 2009 or after December 31, 2010
• Infant not born at Durham County, NC hospital
• Family of infant resides outside of Durham County, NC

Sponsors & Collaborators

• Duke University: lead
• The Duke Endowment: collaborator
• The Pew Charitable Trusts: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

Center for Child and Family Policy, Duke University

Durham, North Carolina, 27708, United States

Location

Related Publications (8)

• Dodge KA, Goodman WB, Murphy RA, O'Donnell K, Sato J, Guptill S. Implementation and randomized controlled trial evaluation of universal postnatal nurse home visiting. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):S136-43. doi: 10.2105/AJPH.2013.301361. Epub 2013 Dec 19.

  PMID: 24354833 RESULT

• Dodge KA, Goodman WB, Murphy RA, O'Donnell K, Sato J. Randomized controlled trial of universal postnatal nurse home visiting: impact on emergency care. Pediatrics. 2013 Nov;132 Suppl 2(Suppl 2):S140-6. doi: 10.1542/peds.2013-1021M.

  PMID: 24187116 RESULT

• Dodge KA, Goodman WB, Murphy R, O'Donnell K, Sato J. Toward Population Impact from Home Visiting. Zero Three. 2013 Jan 1;33(3):17-23.

  PMID: 23526864 RESULT

• Alonso-Marsden S, Dodge KA, O'Donnell KJ, Murphy RA, Sato JM, Christopoulos C. Family risk as a predictor of initial engagement and follow-through in a universal nurse home visiting program to prevent child maltreatment. Child Abuse Negl. 2013 Aug;37(8):555-65. doi: 10.1016/j.chiabu.2013.03.012. Epub 2013 May 6.

  PMID: 23660409 RESULT

• Goodman WB, Dodge KA, Bai Y, O'Donnell KJ, Murphy RA. Randomized controlled trial of Family Connects: Effects on child emergency medical care from birth to 24 months. Dev Psychopathol. 2019 Dec;31(5):1863-1872. doi: 10.1017/S0954579419000889.

  PMID: 31477190 RESULT

• Goodman WB, Dodge KA, Bai Y, Murphy RA, O'Donnell K. Effect of a Universal Postpartum Nurse Home Visiting Program on Child Maltreatment and Emergency Medical Care at 5 Years of Age: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116024. doi: 10.1001/jamanetworkopen.2021.16024.

  PMID: 34232300 RESULT

• 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: 36778074 RESULT

• Baziyants GA, Dodge KA, Bai Y, Goodman WB, O'Donnell K, Murphy RA. The effects of a universal short-term home visiting program: Two-year impact on parenting behavior and parent mental health. Child Abuse Negl. 2023 Jun;140:106140. doi: 10.1016/j.chiabu.2023.106140. Epub 2023 Mar 22.

  PMID: 36963242 RESULT

Related Links

• Center for Child \& Family Policy, Duke University
• Center for Child \& Family Health
• Family Connects Website

Study Officials

• Kenneth 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: July 28, 2011
• First Posted: August 1, 2011
• Study Start: July 1, 2009
• Primary Completion: December 1, 2024
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)