Durham Connects Evaluation II

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Duke Endowment
Coalition for Evidence-Based Policy
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01843036
First received: April 26, 2013
Last updated: July 1, 2014
Last verified: July 2014
  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 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.

  • Child Overnights in Hospital [ Time Frame: 0-66 Months ] [ Designated as safety issue: Yes ]
    Lifetime child overnights in hospital for all overnights unrelated to the birthing stay.

  • Pediatric Well-Care Visit and Child Immunization Compliance Rates [ Time Frame: 0-66 Months ] [ Designated as safety issue: Yes ]
    Lifetime rates of compliance with well-care pediatric visits and immunizations as reported by primary caregiver

  • Mother Postnatal Well-Care Compliance Rates [ Time Frame: 0-12 Months Postnatal ] [ Designated as safety issue: Yes ]
    Rates of mother compliance with postnatal well-care as reported by the mother

  • Mother Emergency Room (ER) Presentation Rates [ Time Frame: 0-66 Months of Child Age ] [ Designated as safety issue: Yes ]
    Total mother emergency department visits reported in hospital records


Estimated Enrollment: 1650
Study Start Date: August 2013
Estimated Study Completion Date: March 2017
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Durham Connects Eligible
From August 1, 2013 - 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 August 1, 2013 - 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.

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 and family health and well-being. The Durham Connects Program is implemented jointly by the Durham County (North Carolina) Health Department, the Center for Child & Family 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 August 1, 2013, through June 30, 2014, all residential births in Durham County, North Carolina (~2,950) will be randomly assigned according to birthdate, with odd-birth-dates assigned to receive DC. Even-birth-dates will be assigned to receive services-as-usual and serve as the randomized control group. Program implementation will be evaluated for all odd-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 empirically-derived areas of family functioning across 4 domains (i.e., healthcare, parenting/childcare, family violence/safety, and maternal well-being). For each area found to be at risk, the nurse intervenes directly to support the mother (mild risk) or connects the mother with ongoing evidence-based interventions in the community (moderate or significant risk). 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 August 1, 2013 and June 30, 2014
  • Infant born at a Durham County, NC hospital (Duke or Durham Regional)
  • Family of infant resides in Durham County, NC

Exclusion Criteria:

  • Infant born between August 1, 2013 and 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
Coalition for Evidence-Based Policy
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:
No publications provided

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: 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
Mother Well-Care Compliance
Mother Hospital Emergency Room Presentations

ClinicalTrials.gov processed this record on August 28, 2014