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Unspecified Child Maltreatment, SuspectedNCT01843036

Durham Connects RCT Evaluation II

A study testing Durham Connects in people with Unspecified Child Maltreatment, Suspected and Unspecified Child Maltreatment, Confirmed, run by Duke University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages Up to 6 months
What is being tested?
Durham Connects
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,650 participants
Where
1 siteUnited States
Study dates
Jan 2014to Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 6 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Infant born between January 1, 2014 and June 30, 2014
  • Infant born at a Durham County, North Carolina (NC) hospital (Duke or Durham Regional)
  • Family of infant resides in Durham County, NC

Who cannot join

  • Infant born before January 1, 2014 or after June 30, 2014
  • Infant not born at a Durham County, NC hospital (Duke or Durham Regional)
  • Family of infant resides outside of Durham County, NC

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Center for Child and Family Policy, Duke University

    Durham, North Carolina, 27708

Other trials in United States

About this study

Official title: Second RCT Evaluation of the Durham Connects Universal Newborn Nurse Home Visiting Program

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.

Read the detailed description

The Durham Connects program is an innovative, community-based, universal nurse home-visiting program that aims to lower the population rate of child maltreatment and improve child and family health and well-being. The Durham Connects Program is implemented jointly by the Durham County (North Carolina) Health Department, the Center for Child \& Family Health, and Duke University. It is designed to be brief and inexpensive per family so that communities can afford its costs. Its goals are consistent with those of more intensive nurse home-visiting programs: 1) to connect with the mother in order to enhance maternal skills and self-efficacy; and 2) to connect the mother with needed community services such as health care, child care, mental health care, and financial and social support; so that 3) the mother can connect with her child.

DC achieves population reach by engaging all families within the community, rapidly triaging families based on identified risk to concentrate resources to families with greater needs, and connecting those families with significant nurse-identified risk to matched community programs and services to provide long-term support and a first step into the community system of care. The program consists of 4-7 manualized intervention contacts, including 1) a hospital birthing visit when a staff member communicates the importance of community support for parenting and schedules an initial home visit; 2) 1-3 nurse home visits between 3-12 weeks of infant age to provide physical assessments for infant and mother, intervention and education, assessment of family-specific needs, and for families with significant nurse-identified risk, connections to matched community resources to provide longer-term support; 3) 1-2 nurse contacts with community service providers to facilitate successful connections; and 4) a telephone follow-up one month after case closure to review consumer satisfaction and community connection outcomes. With family consent, letters from the program reporting on the visit are also provided to also connect families to maternal and infant healthcare providers for ongoing support.

During home visits, the nurse engages the mother (and father, when possible) to provide brief educational interventions for all families (e.g., safe sleep) and utilizes a high-inference approach to assess family needs across 12 empirically-derived factors linked to child health and well-being: Healthcare: parent health, infant health, health care plans; Parenting/childcare: childcare plans, parent-infant relationship, management of infant crying; Family violence/safety: material supports, family violence, maltreatment history; and Parent well-being: depression/anxiety, substance abuse, social/emotional support.

The nurse scores each of the 12 factors and intervenes accordingly. A score of 1 (low risk) receives no subsequent intervention. A score of 2 (moderate risk) receives short-term, nurse-delivered intervention over 1-2 sessions. For a score of 3 (high risk) the nurse connects the family to matched community resources tailored to address that particular risk (such as, treatment for postpartum depression, a DSS social worker exclusively serving Durham Connects families for enrollment in Medicaid or food stamps, a multi-year home visiting program for long-term parent support). The nurse also provides follow up to make sure that each connection "sticks," requiring additional contacts with the family or community agency. A score of 4 (imminent risk) receives emergency intervention (<1% of cases). A final contact four weeks after case closure ascertains community connection outcomes and whether further problem solving is needed to address new or existing needs.

From January 1, 2014, through June 30, 2014, all residential births in Durham County, North Carolina (~1600) will randomly assigned according to birthdate, with odd-birth-dates assigned to receive DC. Even-birth-dates will be assigned to receive services-as-usual and serve as the randomized control group. All eligible families (i.e., families living in Durham County giving birth at one of the two county hospitals) were included with experimental rigor, and without exception, but with ethical care for confidentiality. Hospital discharge records were utilized to confirm eligibility for all RCT families. Program implementation will be evaluated for all odd-birth-date families. The Duke University Health System Institutional Review Board approved all RCT implementation and evaluation procedures.

Completely independent of program implementation, all RCT families were contacted and invited to participate in an independent evaluation of DC short-term impact at infant age 6 months (interviews completed between infant ages 6-8 months). Eligible RCT families were identified using short-form public birth records (i.e., resident Durham County births at one of the two county birthing hospitals) without consideration for intervention participation or adherence. RCT families were contacted and invited to participate in a descriptive research study about family community service use and child development. Families were blind to study goals, and home interviewers were blind to family DC participation status.

*Note - Although all study data collection timepoints are complete, the North Carolina Department of Health and Human Services (NC DHHS) is currently refusing to release final maltreatment records to study investigators. The Study Completion Date has been updated to reflect the additional time needed for Duke University and the investigators to negotiate the release of these records. The delay is unrelated to this study or its investigator team. Rather, the delay is due to discrepancies in data network security standards between NC DHHS and Duke University.

Being tested
Durham Connects
Keywords
Child Abuse, Child Neglect, Child Emergency Medical Care Presentations, Child Well-Care Compliance, Mother Well-Care Compliance, Mother Emergency Medical Care Presentations, Mother Mental Health, Family Connections to Community Resources, Parent-Child Relationship Quality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Durham ConnectsOther

    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).

Study groups in NCT01843036
Study groupRoleWhat they receive
Durham Connects EligibleExperimentalFrom 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.
Receives: Other: Durham Connects
ControlNo interventionFrom 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DSS Investigated and Substantiated Child Maltreatment Rates

    North Carolina Department of Social Services (DSS) reported lifetime cases of investigated and substantiated maltreatment caseness

    Measured: 0 - 12 Years of Child Age

Secondary outcomes (9)
  1. Child Emergency Room (ER) Presentation Rates

    Lifetime child emergency department visits reported in hospital administrative records.

    Measured: 0 - 12 Years of Child Age

  2. Child Overnight Stays in Hospital

    Lifetime child overnight stays in hospital for all overnight stays unrelated to the birthing stay reported in hospital administrative records.

    Measured: 0 - 12 Years of Child Age

  3. Mother Postnatal Well-Care Compliance Rates

    Rates of mother compliance with postnatal well-care as reported by the mother

    Measured: 0-6 Months Postnatal

  4. Child Postnatal Well-Care Compliance Rates

    Rates of infant compliance with postnatal well-care health checks as reported by the mother

    Measured: 0-6 Months Postnatal

  5. Mother Emergency Room (ER) Presentation Rates

    Total mother emergency department visits as reported in hospital administrative records.

    Measured: 0 - 12 Years of Child Age

  6. Mother Overnight Stays in Hospital

    Total mother overnight stays in hospital for all overnight stays unrelated to the birthing stay reported in hospital administrative records.

    Measured: 0 - 12 Years of Child Age

  7. Mother Mental Health

    Rates of mother depressive symptoms and anxiety symptoms as reported by the mother

    Measured: 0-6 Months Postnatal

  8. Family Connections to Community Services/Resources

    Rates of family connections to community resources and services as reported by the mother

    Measured: 0-6 Months Postnatal

  9. Mother Parenting Behaviors

    Rates of mother positive and negative parenting behaviors as reported by the mother

    Measured: 0-6 Months Postnatal

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01843036
Sponsor's protocol ID
Pro00052735
Other IDs
Pro00017478, 1R01HD069981
Status last verified
Aug 2026
First submitted
26 Apr 2013
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dodge KA, Goodman WB, Bai Y, Best DL, Rehder P, Hill S. Impact of a universal perinatal home-visiting program on reduction in race disparities in maternal and child health: Two randomised controlled trials and a field quasi-experiment. Lancet Reg Health Am. 2022 Aug 23;15:100356. doi: 10.1016/j.lana.2022.100356. eCollection 2022 Nov.

    PubMed 36778074
  • Dodge KA, Goodman WB, Bai Y, O'Donnell K, Murphy RA. Effect of a Community Agency-Administered Nurse Home Visitation Program on Program Use and Maternal and Infant Health Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2019 Nov 1;2(11):e1914522. doi: 10.1001/jamanetworkopen.2019.14522.

    PubMed 31675088

Questions about this trial

What is this clinical trial studying?

A study testing Durham Connects in people with Unspecified Child Maltreatment, Suspected and Unspecified Child Maltreatment, Confirmed, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DSS Investigated and Substantiated Child Maltreatment Rates (time frame: 0 - 12 Years of Child Age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01843036, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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