Unspecified Child Maltreatment, SuspectedNCT01406184
Durham Connects RCT Evaluation
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.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Unspecified Child Maltreatment, Suspected, Unspecified Child Maltreatment, Confirmed
- What is being tested?
- Durham Connects
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,329 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to 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 July 1, 2009 and December 31, 2010
- Infant born at Durham County, North Carolina (NC) hospital (Duke or Durham Regional)
- Family of infant resides in Durham County, NC
Who cannot join
- Infant born before July 1, 2009 or after December 31, 2010
- Infant not born at Durham County, NC hospital
- 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
About this study
Official title: RCT Evaluation of the Durham Connects Universal Newborn Nurse Home Visiting Program
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.
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 mother and child health and well-being. The Durham Connects Program is implemented jointly by the Durham County (North Carolina) Department of Public Health, the Center for Child \& Family Health (a community non-profit), 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 July 1, 2009-December 31, 2010, all 4777 resident births from two Durham County hospitals (one academic tertiary care hospital and one community hospital) were randomized at the even-odd birth date group level, with families assigned to one of two intervention groups based on infant birth date: 1) even birth date families (n=2327) were randomly assigned to receive DC; DC staff attempted to schedule and visit all even birth date families; 2) odd birth date families (n=2450) were randomly assigned to receive other community services as usual and served as the 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. The Duke University Health System Institutional Review Board approved all RCT implementation and evaluation procedures.
Completely independent of program implementation, a random, representative subsample of 549 families was selected to conduct an independent evaluation of DC beginning at infant age 6 months (initial interviews completed between infant ages 6-8 months). Use of random subsamples for evaluation of population-level interventions allows for testing of intervention impact while minimizing evaluation costs (e.g., Moving to Opportunity for Fair Housing intervention15). Consistent with this evaluation strategy, one family was randomly selected by computer algorithm from public birth records for each of the 549 days of the 18-month RCT enrollment period in order to examine program impact for families enrolled across the entire trial period. Families were selected from the entire population of eligible birth records (i.e., resident Durham County births at one of the two county birthing hospitals) without consideration for intervention participation or adherence. Selected families that declined participation were replaced with a randomly selected family with the same child birth date and race/ethnicity as the original family, in order to preserve any lack of selection bias based on these characteristics.
Selected 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. Overall, 682 families were randomly selected and 549 (81%) participated (n=269 DC-eligible families; n=280 control families). Post-hoc comparisons of hospital discharge records and public birth records after all evaluation study consenting and interviews were complete identified 18 participating families that were subsequently declared ineligible due to hospital discharge record error (n=13 families with no hospital discharge record; n=3 families with child birth date discrepancies; and n=2 families with address discrepancies affecting Durham County residency), resulting in a final sample of 664 selected families and 531 participating families. The ineligible families (n=9 DC-eligible families; n=9 control families) were removed without consideration for intervention adherence or evaluation outcomes.
*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 Hospital Emergency Room Presentations, Child Well-Care Compliance, Child Immunization Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durham ConnectsOther
The program consists of 4-7 intervention contacts, including 1) a hospital birthing visit when a staff member 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 connections to matched community resources, as needed, 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Durham Connects Eligible Group | Experimental | 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. Receives: Other: Durham Connects |
| Control Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DSS Investigated and Substantiated Child Maltreatment Rates
North Carolina Department of Social Services (DSS) reported lifetime cases of investigated and substantiated maltreatment cases.
Measured: 0 - 12 Years of Child Age
Secondary outcomes (7)
Child Emergency Room (ER) Presentation Rates
Lifetime child emergency department visits reported in hospital administrative records
Measured: 0 - 12 Years of Child Age
Child Overnight Stays in Hospital
Lifetime child overnight stays in hospital for all overnight stays unrelated to the birthing stay as reported in hospital administrative records.
Measured: 0 - 12 Years Months of Child Age
Child Postnatal Well-Care Compliance Rates
Rates of child compliance with well-care pediatric visits as reported by the mother
Measured: 0 - 24 Months of Child Age
Child Social-Emotional Competence and Behavior Problems
Mothers complete the Head Start Competence Scale (Domitrovich et al., 2001), measuring child social and emotional skills central to interpersonal relationships and emotion regulation. Mothers also complete the ages 1.5-5 version of the Child Behavior Checklist (CBCL 1.5-5; Achenbach \& Rescorla, 2001), a standardized measure assessing emotional and behavioral problems, including: 1) affective problems; 2) anxiety problems; 3) pervasive developmental problems; 4) Attention Deficit/Hyperactivity problems; and 5) Oppositional Defiant problems.
Measured: 24 - 66 Months of Child Age
Mother Mental Health
Rates of mother depressive symptoms and anxiety symptoms as reported by the mother
Measured: 0-66 Months of Child Age
Family Connections to Community Services/Resources
Rates of family connections to community resources and services as reported by the mother
Measured: 0-66 Months of Child Age
Mother Parenting Behaviors
Rates of mother positive and negative parenting behaviors as reported by the mother or rated by an independent observer during in-home interviews or videotaped parent-child interactions
Measured: 0-66 Months of Child Age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startJul 2009
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Unspecified Child Maltreatment, SuspectedStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 2,329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The Duke Endowment, The Pew Charitable Trusts, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Kenneth Dodge, Ph.D., Principal investigator, Duke UniversityRobert Murphy, Ph.D., Principal investigator, Center for Child & Family HealthKaren O'Donnell, Ph.D., Principal investigator, Center for Child & Family HealthW. Benjamin Goodman, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406184
- Sponsor's protocol ID
- Pro00020974
- Other IDs
- Pro00017478, 1R01HD069981, Pro00020974, Pro00027652
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2011
- 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, Murphy RA, O'Donnell K, Sato J, Guptill S. Implementation and randomized controlled trial evaluation of universal postnatal nurse home visiting. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):S136-43. doi: 10.2105/AJPH.2013.301361. Epub 2013 Dec 19.
PubMed 24354833Dodge KA, Goodman WB, Murphy RA, O'Donnell K, Sato J. Randomized controlled trial of universal postnatal nurse home visiting: impact on emergency care. Pediatrics. 2013 Nov;132 Suppl 2(Suppl 2):S140-6. doi: 10.1542/peds.2013-1021M.
PubMed 24187116Dodge KA, Goodman WB, Murphy R, O'Donnell K, Sato J. Toward Population Impact from Home Visiting. Zero Three. 2013 Jan 1;33(3):17-23.
PubMed 23526864Alonso-Marsden S, Dodge KA, O'Donnell KJ, Murphy RA, Sato JM, Christopoulos C. Family risk as a predictor of initial engagement and follow-through in a universal nurse home visiting program to prevent child maltreatment. Child Abuse Negl. 2013 Aug;37(8):555-65. doi: 10.1016/j.chiabu.2013.03.012. Epub 2013 May 6.
PubMed 23660409Goodman WB, Dodge KA, Bai Y, O'Donnell KJ, Murphy RA. Randomized controlled trial of Family Connects: Effects on child emergency medical care from birth to 24 months. Dev Psychopathol. 2019 Dec;31(5):1863-1872. doi: 10.1017/S0954579419000889.
PubMed 31477190Goodman WB, Dodge KA, Bai Y, Murphy RA, O'Donnell K. Effect of a Universal Postpartum Nurse Home Visiting Program on Child Maltreatment and Emergency Medical Care at 5 Years of Age: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116024. doi: 10.1001/jamanetworkopen.2021.16024.
PubMed 34232300Dodge 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 36778074Baziyants GA, Dodge KA, Bai Y, Goodman WB, O'Donnell K, Murphy RA. The effects of a universal short-term home visiting program: Two-year impact on parenting behavior and parent mental health. Child Abuse Negl. 2023 Jun;140:106140. doi: 10.1016/j.chiabu.2023.106140. Epub 2023 Mar 22.
PubMed 36963242Baziyants GA, Dodge KA, Goodman WB, Bai Y, Murphy RA, O'Donnell K. Promoting Long-Term Parent and Caregiver Mental Health Through Universal Postnatal Nurse Home Visiting: Intervention Effects and Mechanisms of Action. Prev Sci. 2025 Aug;26(6):921-931. doi: 10.1007/s11121-025-01827-6. Epub 2025 Aug 1.
PubMed 40748529
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT Evaluation of the Durham Connects Universal Newborn Nurse Home Visiting Program
- ClinicalTrials.gov ID
- NCT01406184
- Acronym / sponsor ID
- Pro00020974
- Keywords
- Child Abuse, Child Neglect, Child Hospital Emergency Room Presentations, Child Well-Care Compliance, Child Immunization Compliance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,329 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- The Duke Endowment, The Pew Charitable Trusts, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Robert Wood Johnson Foundation
- Study start
- Jul 2009 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 mother and child health and well-being. The Durham Connects Program is implemented jointly by the Durham County (North Carolina) Department of Public Health, the Center for Child \& Family Health (a community non-profit), 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 July 1, 2009-December 31, 2010, all 4777 resident births from two Durham County hospitals (one academic tertiary care hospital and one community hospital) were randomized at the even-odd birth date group level, with families assigned to one of two intervention groups based on infant birth date: 1) even birth date families (n=2327) were randomly assigned to receive DC; DC staff attempted to schedule and visit all even birth date families; 2) odd birth date families (n=2450) were randomly assigned to receive other community services as usual and served as the 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. The Duke University Health System Institutional Review Board approved all RCT implementation and evaluation procedures.
Completely independent of program implementation, a random, representative subsample of 549 families was selected to conduct an independent evaluation of DC beginning at infant age 6 months (initial interviews completed between infant ages 6-8 months). Use of random subsamples for evaluation of population-level interventions allows for testing of intervention impact while minimizing evaluation costs (e.g., Moving to Opportunity for Fair Housing intervention15). Consistent with this evaluation strategy, one family was randomly selected by computer algorithm from public birth records for each of the 549 days of the 18-month RCT enrollment period in order to examine program impact for families enrolled across the entire trial period. Families were selected from the entire population of eligible birth records (i.e., resident Durham County births at one of the two county birthing hospitals) without consideration for intervention participation or adherence. Selected families that declined participation were replaced with a randomly selected family with the same child birth date and race/ethnicity as the original family, in order to preserve any lack of selection bias based on these characteristics.
Selected 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. Overall, 682 families were randomly selected and 549 (81%) participated (n=269 DC-eligible families; n=280 control families). Post-hoc comparisons of hospital discharge records and public birth records after all evaluation study consenting and interviews were complete identified 18 participating families that were subsequently declared ineligible due to hospital discharge record error (n=13 families with no hospital discharge record; n=3 families with child birth date discrepancies; and n=2 families with address discrepancies affecting Durham County residency), resulting in a final sample of 664 selected families and 531 participating families. The ineligible families (n=9 DC-eligible families; n=9 control families) were removed without consideration for intervention adherence or evaluation outcomes.
*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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Durham Connects Eligible Group | Experimental | Other: Durham ConnectsFrom 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. |
| Control Group | No 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 may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infant born between July 1, 2009 and December 31, 2010
- Infant born at Durham County, North Carolina (NC) hospital (Duke or Durham Regional)
- Family of infant resides in Durham County, NC
Key exclusion criteria (3 listed)
- Infant born before July 1, 2009 or after December 31, 2010
- Infant not born at Durham County, NC hospital
- Family of infant resides outside of Durham County, NC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Durham ConnectsThe program consists of 4-7 intervention contacts, including 1) a hospital birthing visit when a staff member 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 connections to matched community resources, as needed, 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 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. | Other | Durham Connects Eligible Group |
Primary outcome
DSS Investigated and Substantiated Child Maltreatment Rates
Time frame: 0 - 12 Years of Child Age
North Carolina Department of Social Services (DSS) reported lifetime cases of investigated and substantiated maltreatment cases.
7 secondary outcomes
Child Emergency Room (ER) Presentation Rates
Time frame: 0 - 12 Years of Child Age
Child Overnight Stays in Hospital
Time frame: 0 - 12 Years Months of Child Age
Child Postnatal Well-Care Compliance Rates
Time frame: 0 - 24 Months of Child Age
Child Social-Emotional Competence and Behavior Problems
Time frame: 24 - 66 Months of Child Age
Mother Mental Health
Time frame: 0-66 Months of Child Age
Family Connections to Community Services/Resources
Time frame: 0-66 Months of Child Age
Mother Parenting Behaviors
Time frame: 0-66 Months of Child Age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Results publication: PubMed 24354833Dodge KA, Goodman WB, Murphy RA, O'Donnell K, Sato J, Guptill S. Implementation and randomized controlled trial evaluation of universal postnatal nurse home visiting. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):S136-43. doi: 10.2105/AJPH.2013.301361. Epub 2013 Dec 19.
- Results publication: PubMed 24187116Dodge KA, Goodman WB, Murphy RA, O'Donnell K, Sato J. Randomized controlled trial of universal postnatal nurse home visiting: impact on emergency care. Pediatrics. 2013 Nov;132 Suppl 2(Suppl 2):S140-6. doi: 10.1542/peds.2013-1021M.
- Results publication: PubMed 23526864Dodge KA, Goodman WB, Murphy R, O'Donnell K, Sato J. Toward Population Impact from Home Visiting. Zero Three. 2013 Jan 1;33(3):17-23.
- Results publication: PubMed 23660409Alonso-Marsden S, Dodge KA, O'Donnell KJ, Murphy RA, Sato JM, Christopoulos C. Family risk as a predictor of initial engagement and follow-through in a universal nurse home visiting program to prevent child maltreatment. Child Abuse Negl. 2013 Aug;37(8):555-65. doi: 10.1016/j.chiabu.2013.03.012. Epub 2013 May 6.
- Results publication: PubMed 31477190Goodman WB, Dodge KA, Bai Y, O'Donnell KJ, Murphy RA. Randomized controlled trial of Family Connects: Effects on child emergency medical care from birth to 24 months. Dev Psychopathol. 2019 Dec;31(5):1863-1872. doi: 10.1017/S0954579419000889.
- Results publication: PubMed 34232300Goodman WB, Dodge KA, Bai Y, Murphy RA, O'Donnell K. Effect of a Universal Postpartum Nurse Home Visiting Program on Child Maltreatment and Emergency Medical Care at 5 Years of Age: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116024. doi: 10.1001/jamanetworkopen.2021.16024.
- Results publication: PubMed 36778074Dodge 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.
- Results publication: PubMed 36963242Baziyants GA, Dodge KA, Bai Y, Goodman WB, O'Donnell K, Murphy RA. The effects of a universal short-term home visiting program: Two-year impact on parenting behavior and parent mental health. Child Abuse Negl. 2023 Jun;140:106140. doi: 10.1016/j.chiabu.2023.106140. Epub 2023 Mar 22.
- Results publication: PubMed 40748529Baziyants GA, Dodge KA, Goodman WB, Bai Y, Murphy RA, O'Donnell K. Promoting Long-Term Parent and Caregiver Mental Health Through Universal Postnatal Nurse Home Visiting: Intervention Effects and Mechanisms of Action. Prev Sci. 2025 Aug;26(6):921-931. doi: 10.1007/s11121-025-01827-6. Epub 2025 Aug 1.
- Center for Child \& Family Policy, Duke UniversityLink provided by the sponsor.
- Center for Child \& Family HealthLink provided by the sponsor.
- Family Connects WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Unspecified Child Maltreatment, Suspected
Active, not recruiting
Durham Connects RCT Evaluation II
Unspecified Child Maltreatment, Suspected, Unspecified Child Maltreatment, Confirmed
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Dodge, 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
1 site in 1 country: see every site and its status.
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 NCT01406184, which also lists 9 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; AzTrials last refreshed its copy on 26 Oct 2026.