Durham Connects RCT Evaluation II
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|ClinicalTrials.gov Identifier: NCT01843036|
Recruitment Status : Active, not recruiting
First Posted : April 30, 2013
Last Update Posted : May 21, 2020
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 or disease||Intervention/treatment||Phase|
|Unspecified Child Maltreatment, Suspected Unspecified Child Maltreatment, Confirmed||Other: Durham Connects||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1650 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Second RCT Evaluation of the Durham Connects Universal Newborn Nurse Home Visiting Program|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||June 2026|
|Estimated Study Completion Date :||June 2026|
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.
- DSS Investigated and Substantiated Child Maltreatment Rates [ Time Frame: 0 - 12 Years of Child Age ]North Carolina Department of Social Services (DSS) reported lifetime cases of investigated and substantiated maltreatment caseness
- Child Emergency Room (ER) Presentation Rates [ Time Frame: 0 - 12 Years of Child Age ]Lifetime child emergency department visits reported in hospital administrative records.
- Child Overnight Stays in Hospital [ Time Frame: 0 - 12 Years of Child Age ]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 ]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 ]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 ]Total mother emergency department visits as reported in hospital administrative records.
- Mother Overnight Stays in Hospital [ Time Frame: 0 - 12 Years of Child Age ]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 ]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 ]Rates of family connections to community resources and services as reported by the mother
- Mother Parenting Behaviors [ Time Frame: 0-6 Months Postnatal ]Rates of mother positive and negative parenting behaviors as reported by the mother
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843036
|United States, North Carolina|
|Center for Child and Family Policy, Duke University|
|Durham, North Carolina, United States, 27708|
|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|