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Durham Connects RCT Evaluation II

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Duke Endowment
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Coalition for Evidence-Based Policy
Laura and John Arnold Foundation
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01843036
First received: April 26, 2013
Last updated: August 29, 2016
Last verified: August 2016
  Purpose

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.


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: Second 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 of Child Age ] [ Designated as safety issue: Yes ]
    Lifetime child overnight stays in hospital for all overnight stays unrelated to the birthing stay reported in hospital administrative records.

  • Mother Postnatal Well-Care Compliance Rates [ Time Frame: 0-6 Months Postnatal ] [ Designated as safety issue: Yes ]
    Rates of mother compliance with postnatal well-care as reported by the mother

  • Child Postnatal Well-Care Compliance Rates [ Time Frame: 0-6 Months Postnatal ] [ Designated as safety issue: Yes ]
    Rates of infant compliance with postnatal well-care health checks as reported by the mother

  • Mother Emergency Room (ER) Presentation Rates [ Time Frame: 0 - 12 Years of Child Age ] [ Designated as safety issue: Yes ]
    Total mother emergency department visits as reported in hospital administrative records.

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

  • Mother Mental Health [ Time Frame: 0-6 Months Postnatal ] [ 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: 0-6 Months Postnatal ] [ Designated as safety issue: No ]
    Rates of family connections to community resources and services as reported by the mother

  • Mother Parenting Behaviors [ Time Frame: 0-6 Months Postnatal ] [ Designated as safety issue: No ]
    Rates of mother positive and negative parenting behaviors as reported by the mother


Estimated Enrollment: 1650
Study Start Date: January 2014
Estimated Study Completion Date: June 2026
Estimated Primary Completion Date: June 2026 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Durham Connects Eligible
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
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).
No Intervention: Control
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.

  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 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

Exclusion Criteria:

  • 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
  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: NCT01843036

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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Coalition for Evidence-Based Policy
Laura and John Arnold Foundation
Investigators
Principal Investigator: 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
  More Information

Additional Information:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01843036     History of Changes
Other Study ID Numbers: Pro00017478_Amd6  Pro00052735  1R01HD069981 
Study First Received: April 26, 2013
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 Emergency Medical Care Presentations
Child Well-Care Compliance
Mother Well-Care Compliance
Mother Emergency Medical Care Presentations
Mother Mental Health
Family Connections to Community Resources
Parent-Child Relationship Quality

ClinicalTrials.gov processed this record on December 09, 2016