Durham Connects for Preventing Child Abuse

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Infant birth date, Birth location, Residence location

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

2329 Participants Needed

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Durham Connects for preventing child abuse?

The Durham Family Initiative, which shares principles with Durham Connects, aims to reduce child abuse by focusing on nurturing healthy parent-child relationships, and has a community collaborative to implement these principles. Additionally, a study on differential response programs in child protective services showed improved family engagement and reduced child maltreatment, suggesting that similar approaches may be effective. ^{1 2 3 4 5}

How is the Durham Connects treatment different from other treatments for preventing child abuse?

Durham Connects is unique because it is a universal postnatal nurse home visiting program that provides brief interventions and connects families with more intensive services if needed, focusing on improving parenting behaviors and mental health to prevent child abuse. ^{2 6 7 8 9}

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Home Visit

A hospital birthing visit where a staff member communicates the importance of community support for parenting and schedules an initial home visit

1 week

1 visit (in-person)

Nurse Home Visits

1-3 nurse home visits between 3-12 weeks of infant age to provide physical assessments for infant and mother, intervention and education, and assessment of family-specific needs

9 weeks

1-3 visits (in-person)

Community Service Connection

1-2 nurse contacts with community service providers to facilitate successful connections for families with significant nurse-identified risk

4 weeks

Follow-up

A telephone follow-up one month after case closure to review consumer satisfaction and community connection outcomes

4 weeks

Treatment Details

Interventions

• Durham Connects

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+

Robert Wood Johnson Foundation

Collaborator

Trials

161

Recruited

697,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

The Pew Charitable Trusts

Collaborator

Trials

4

Recruited

3,100+

The Duke Endowment

Collaborator

Trials

17

Recruited

48,100+

Findings from Research

In a study of 595 children, those who underwent investigations for suspected child maltreatment did not show significant improvements in key risk factors like social support, family functioning, or child behavior by age 8, compared to those who were not investigated.

The findings suggest that Child Protection Services investigations may not effectively address or improve the underlying risk factors associated with child maltreatment, indicating a potential gap in secondary prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Household, family, and child risk factors after an investigation for suspected child maltreatment: a missed opportunity for prevention. Campbell, KA., Cook, LJ., LaFleur, BJ., et al.[2021]

The Family Success Network, a pilot program in Northeast Ohio, aims to prevent child maltreatment by addressing social determinants of health, such as socioeconomic status and intergenerational trauma, through various support services.

The initiative includes family coaching, financial assistance, and parenting education, with the goal of improving family functioning and reducing the need for child protective services and foster care in economically disadvantaged areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Determinants of Health and Child Maltreatment Prevention: The Family Success Network Pilot. Johnson-Motoyama, M., Moon, D., Rolock, N., et al.[2023]

The North Carolina Plan of Safe Care (NC POSC) was implemented to support substance-affected infants and their families, but many healthcare providers were unaware of the program, highlighting a need for better communication and education among stakeholders.

From January 2018 to October 2019, 91% of notifications for substance-affected infants were screened for maltreatment, with a significant portion (70%) related to prenatal marijuana exposure, indicating a critical area for intervention and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the North Carolina Plan of Safe Care in Wake County, North Carolina. Austin, AE., Shanhan, ME., Rosemond, P., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Household, family, and child risk factors after an investigation for suspected child maltreatment: a missed opportunity for prevention. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The Durham Family Initiative: a preventive system of care. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Protocol for developing core outcome sets for evaluation of psychosocial interventions for children and families with experience or at risk of child maltreatment or domestic abuse. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Effects of approach and services under differential response on long term child safety and welfare. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Social Determinants of Health and Child Maltreatment Prevention: The Family Success Network Pilot. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Implementation of the North Carolina Plan of Safe Care in Wake County, North Carolina. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The effects of a universal short-term home visiting program: Two-year impact on parenting behavior and parent mental health. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Preventing child maltreatment in North Carolina. [2011]

9. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of universal postnatal nurse home visiting: impact on emergency care. [2021]