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Durham Connects RCT Evaluation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Duke Endowment
The Pew Charitable Trusts
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01406184
First received: July 28, 2011
Last updated: August 29, 2016
Last verified: April 2016
  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: RCT Evaluation of the Durham Connects Universal Newborn Nurse Home Visiting Program

Further study details as provided by Duke University:

Primary Outcome Measures:
  • DSS Investigated and Substantiated Child Maltreatment Rates [ Time Frame: 0 - 12 Years of Child Age ] [ Designated as safety issue: Yes ]
    North Carolina Department of Social Services (DSS) reported lifetime cases of investigated and substantiated maltreatment caseness


Secondary Outcome Measures:
  • Child Emergency Room (ER) Presentation Rates [ Time Frame: 0 - 12 Years of Child Age ] [ Designated as safety issue: Yes ]
    Lifetime child emergency department visits reported in hospital administrative records

  • Child Overnight Stays in Hospital [ Time Frame: 0 - 12 Years Months of Child Age ] [ Designated as safety issue: Yes ]
    Lifetime child overnight stays in hospital for all overnight stays unrelated to the birthing stay as reported in hospital administrative records.

  • Child Postnatal Well-Care Compliance Rates [ Time Frame: 0 - 24 Months of Child Age ] [ Designated as safety issue: Yes ]
    Rates of child compliance with well-care pediatric visits as reported by the mother

  • 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 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.

  • Mother Mental Health [ Time Frame: 0-66 Months of Child Age ] [ Designated as safety issue: Yes ]
    Rates of mother depressive symptoms and anxiety symptoms as reported by the mother

  • Family Connections to Community Services/Resources [ Time Frame: 0-66 Months of Child Age ] [ Designated as safety issue: No ]
    Rates of family connections to community resources and services as reported by the mother

  • Mother Parenting Behaviors [ Time Frame: 0-66 Months of Child Age ] [ Designated as safety issue: No ]
    Rates of mother positive and negative parenting behaviors as reported by the mother or rated by an independent observer during in-home interviews or videotaped parent-child interactions


Enrollment: 2329
Study Start Date: July 2009
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (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
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.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 6 Months   (Child)
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, North Carolina (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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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  Pro00020974  Pro00027652 
Study First Received: July 28, 2011
Last Updated: August 29, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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 28, 2016