Durham Connects for Preventing Child Abuse

Recruiting in Palo Alto (17 mi)

Overseen by Karen O'Donnell, 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 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.

Research Team

Kenneth Dodge, Ph.D.

Principal Investigator

Duke University

W. Benjamin Goodman, Ph.D.

Principal Investigator

Duke University

Robert Murphy, Ph.D.

Principal Investigator

Center for Child & Family Health

Karen O'Donnell, Ph.D.

Principal Investigator

Center for Child & Family Health

Eligibility Criteria

This trial is for families with infants born in Durham County, NC hospitals between July 1, 2009 and December 31, 2010. It aims to help prevent child maltreatment and improve child well-being. Families living outside of Durham County or with infants born before or after these dates cannot participate.

Inclusion Criteria

My child was born between July 1, 2009, and December 31, 2010.

Family of infant resides in Durham County, NC

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

Exclusion Criteria

Family of infant resides outside of Durham County, NC

My child was not born between July 1, 2009, and December 31, 2010.

Infant not born at Durham County, NC hospital

Treatment Details

Interventions

• Durham Connects (Behavioural Intervention)

Trial Overview The 'Durham Connects' program is being tested through a randomized controlled trial to see if it lowers the rates of child abuse and improves pediatric care, parental functioning, and overall child well-being compared to those who do not receive the intervention.

Participant Groups

Group I: Durham Connects Eligible Group Experimental Treatment 1 Intervention

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.

Group II: Control Group Active Control 1 Intervention

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.

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

Robert Wood Johnson Foundation

Collaborator

Trials

161

Recruited

697,000+

Dr. Kemi Alli

Robert Wood Johnson Foundation

Chief Medical Officer since 2015

MD from Brown University

Dr. Richard E. Besser

Robert Wood Johnson Foundation

Chief Executive Officer since 2017

MD from the University of Pennsylvania

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

The Pew Charitable Trusts

Collaborator

Trials

4

Recruited

3,100+

The Duke Endowment

Collaborator

Trials

17

Recruited

48,100+