Durham Connects Evaluation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Duke Endowment
The Pew Charitable Trusts
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01406184
First received: July 28, 2011
Last updated: July 1, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Unspecified Child Maltreatment, Suspected
Unspecified Child Maltreatment, Confirmed
Other: Durham Connects

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of the Durham Connects Nurse Home Visiting Program

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • DSS Investigated and Substantiated Child Maltreatment Rates [ Time Frame: 0 - 66 months of child age ] [ Designated as safety issue: Yes ]
    North Carolina Department of Social Services (DSS) reported lifetime caseness of investigated and substantiated maltreatment caseness


Secondary Outcome Measures:
  • Child Emergency Room (ER) Presentation Rates [ Time Frame: 0 - 66 Months of Child Age ] [ Designated as safety issue: Yes ]
    Lifetime child emergency department visit reported in hospital records for an injury with a maltreatment-related diagnostic code.

  • Pediatric Well-Care Visit and Child Immunization Compliance Rates [ Time Frame: 0 - 66 Months of Child Age ] [ Designated as safety issue: Yes ]
    Lifetime rates of compliance with well-care pediatric visits and immunizations as reported in pediatric records; lifetime child injuries reported in pediatric records.

  • Child Social-Emotional Competence and Behavior Problems [ Time Frame: 24 - 66 Months of Child Age ] [ Designated as safety issue: No ]
    Mothers complete the Head Start Competence Scale (Domitrovich et al., 2001), measuring child social and emotional skills central to interpersonal relationships and emotion regulation. Mothers also complete the ages 1.5-5 version of the Child Behavior Checklist (CBCL 1.5-5; Achenbach & Rescorla, 2001), a standardized measure assessing DSM-oriented emotional and behavioral problems, including: 1) affective problems; 2) anxiety problems; 3) pervasive developmental problems; 4) Attention Deficit/Hyperactivity problems; and 5) Oppositional Defiant problems.


Enrollment: 2329
Study Start Date: July 2009
Estimated Study Completion Date: March 2017
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Durham Connects Eligible Group
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
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 domains of family functioning. For each domain found to be at risk, the nurse intervenes directly to support the mother or connects the mother with ongoing evidence-based interventions in the community
No Intervention: Control Group
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.

Detailed Description:

The Durham Connects Program is an innovative, community based, universal nurse home-visiting program that aims to lower the population rate of child maltreatment and improve child well-being. The Durham Connects Program is implemented jointly by the Durham County (North Carolina) Department of Health and Duke University. It is designed to be brief and inexpensive per family so that communities can afford its costs. Its goals are consistent with those of more intensive nurse home-visiting programs: 1) to connect with the mother in order to enhance maternal skills and self-efficacy; and 2) to connect the mother with needed community services such as health care, child care, mental health care, and financial and social support; so that 3) the mother can connect with her child.

From July 1, 2009, through December 31, 2010, all 4,782 residential births in Durham County, North Carolina, were randomly assigned according to birthdate, with even-birth-dates assigned to receive DC. Odd-birth-dates were assigned to receive services-as-usual and served as the control group. Program implementation was evaluated for all 2,330 even-birth-date families.

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 domains of family functioning. For each domain found to be at risk, the nurse intervenes directly to support the mother or connects the mother with ongoing evidence-based interventions in the community. Although Durham Connects is implemented universally, it focuses on triaging families according to assessed risk and then connecting them with ongoing collaborating community resources that can "carry the family's baton" after the nurse home-visitor leaves the family.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infant born between July 1, 2009 and December 31, 2010
  • Infant born at Durham County, NC hospital (Duke or Durham Regional)
  • Family of infant resides in Durham County, NC

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406184

Locations
United States, North Carolina
Center for Child and Family Policy, Duke University
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
Duke University
The Duke Endowment
The Pew Charitable Trusts
Robert Wood Johnson Foundation
Investigators
Principal Investigator: 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
  More Information

Additional Information:
Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01406184     History of Changes
Other Study ID Numbers: Pro00020974, Pro00017478, 1R01HD069981
Study First Received: July 28, 2011
Last Updated: July 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Child Abuse
Child Neglect
Child Hospital Emergency Room Presentations
Child Well-Care Compliance
Child Immunization Compliance

ClinicalTrials.gov processed this record on September 14, 2014