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.
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
- 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
- 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
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 group | Role | What they receive |
|---|---|---|
| Durham Connects Eligible | Experimental | 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. Receives: Other: Durham Connects |
| Control | No 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. |
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 caseness
Measured: 0 - 12 Years of Child Age
Secondary outcomes (9)
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 reported in hospital administrative records.
Measured: 0 - 12 Years of Child Age
Mother Postnatal Well-Care Compliance Rates
Rates of mother compliance with postnatal well-care as reported by the mother
Measured: 0-6 Months Postnatal
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
Mother Emergency Room (ER) Presentation Rates
Total mother emergency department visits as reported in hospital administrative records.
Measured: 0 - 12 Years of Child Age
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
Mother Mental Health
Rates of mother depressive symptoms and anxiety symptoms as reported by the mother
Measured: 0-6 Months Postnatal
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
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.
- First posted30 Apr 2013 (estimated)
- Study startJan 2014
- 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 (2)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
- 1,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The Duke Endowment, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Coalition for Evidence-Based Policy, Laura and John Arnold Foundation
- Responsible party
- Sponsor
- Investigators
- Kenneth A 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
- 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 36778074Dodge 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
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
- Second RCT Evaluation of the Durham Connects Universal Newborn Nurse Home Visiting Program
- ClinicalTrials.gov ID
- NCT01843036
- Acronym / sponsor ID
- Pro00052735
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,650 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- The Duke Endowment, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Coalition for Evidence-Based Policy, Laura and John Arnold Foundation
- Study start
- Jan 2014
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 30 Apr 2013 (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 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.
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.
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 | Experimental | Other: Durham ConnectsFrom 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. |
| Control | No 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 may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 ConnectsDurham 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). | Other | Durham Connects Eligible |
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 caseness
9 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 of Child Age
Mother Postnatal Well-Care Compliance Rates
Time frame: 0-6 Months Postnatal
Child Postnatal Well-Care Compliance Rates
Time frame: 0-6 Months Postnatal
Mother Emergency Room (ER) Presentation Rates
Time frame: 0 - 12 Years of Child Age
Mother Overnight Stays in Hospital
Time frame: 0 - 12 Years of Child Age
Mother Mental Health
Time frame: 0-6 Months Postnatal
Family Connections to Community Services/Resources
Time frame: 0-6 Months Postnatal
Mother Parenting Behaviors
Time frame: 0-6 Months Postnatal
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.
- Background: 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 31675088Dodge 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.
- Family Connects International WebsiteLink provided by the sponsor.
- Center for Child and Family Policy, Duke UniversityLink provided by the sponsor.
- Center for Child \& Family HealthLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Unspecified Child Maltreatment, Suspected
Active, not recruiting
Durham Connects RCT Evaluation
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 A 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 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.