Durham Connects Program for Child Abuse Prevention

Overseen by Robert Murphy, Ph.D.

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Duke University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

W. Benjamin Goodman, Ph.D.

Principal Investigator

Duke University

Karen O'Donnell, Ph.D.

Principal Investigator

Center for Child & Family Health

Kenneth A Dodge, Ph.D.

Principal Investigator

Duke University

Robert Murphy, Ph.D.

Principal Investigator

Center for Child & Family Health

Eligibility Criteria

This trial is for families with infants born between January 1, 2014 and June 30, 2014 in Durham County, NC hospitals. It aims to help prevent child maltreatment and boost family health. Families living outside of Durham County or with infants born outside the specified dates cannot participate.

Inclusion Criteria

Family of infant resides in Durham County, NC

My child was born between January 1, 2014, and June 30, 2014.

Infant born at a Durham County, North Carolina (NC) hospital (Duke or Durham Regional)

Exclusion Criteria

Infant not born at a Durham County, NC hospital (Duke or Durham Regional)

My child was born outside the period of January 1 to June 30, 2014.

Family of infant resides outside of Durham County, NC

Treatment Details

Interventions

• Durham Connects (Behavioural Intervention)

Trial Overview The trial evaluates the 'Durham Connects' program which involves nurse home visits to support child and family well-being. The study will see if this leads to lower rates of child abuse, better pediatric care, improved parental functioning, and enhanced child well-being compared to a control group.

Participant Groups

Group I: Durham Connects Eligible Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

Laura and John Arnold Foundation

Collaborator

Trials

13

Recruited

30,500+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

Coalition for Evidence-Based Policy

Collaborator

Trials

1

Recruited

1,700+

The Duke Endowment

Collaborator

Trials

17

Recruited

48,100+