Durham Connects Program for Child Abuse Prevention

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: 3

1650 Participants Needed

Trial Summary

Do I need to stop my current medications to join 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 in the Durham Connects Program for Child Abuse Prevention?

The Durham Family Initiative aims to reduce child abuse by 50% in Durham, North Carolina, by focusing on nurturing healthy parent-child relationships, which is a key component of the Durham Connects Program. Additionally, universal nurse home visiting programs, similar to Durham Connects, have shown promise in preventing child maltreatment by engaging families early. ^{1 2 3 4 5}

How does the Durham Connects treatment differ from other treatments for child abuse prevention?

The Durham Connects program is unique because it offers universal postnatal nurse home visits to screen for risks and provide brief interventions, connecting families with more intensive services if needed. This approach is distinct from other treatments as it focuses on early intervention and community collaboration to prevent child abuse. ^{1 5 6 7 8}

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

Karen O'Donnell, Ph.D.

Principal Investigator

Center for Child & Family Health

W. Benjamin Goodman, Ph.D.

Principal Investigator

Duke University

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 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 visit

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

2 weeks

Follow-up

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

4 weeks

1 visit (virtual)

Treatment Details

Interventions

• Durham Connects

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+

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+

Coalition for Evidence-Based Policy

Collaborator

Trials

1

Recruited

1,700+

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 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]

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]

References

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

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

2. 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]

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Family risk as a predictor of initial engagement and follow-through in a universal nurse home visiting program to prevent child maltreatment. [2022]

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

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

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

The New York City neighborhood-based services strategy. [2005]

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

Statewide coverage of very low birth-weight infants and young teenage mothers in North Carolina's Child Service Coordination Program. [2019]