Child DevelopmentNCT04019977
Effects of Early Community Services on Child and Family Development
A study testing Nurse Home Visiting Program in people with Child Development, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
The purpose of the current study is to evaluate the effects on early child development of early community services, including a brief nurse home visiting program. Investigators hypothesize that nurse home visiting program participants will be significantly different than non- nurse home visiting program participants… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Nurse Home Visiting Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 277 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jul 2019to 19 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mother and Infant are Baltimore City Residents
- Mother gave birth to infant at Sinai Hospital in Baltimore, MD beginning approximately July 15, 2019
- Mother speaks English
Who cannot join
- Mother and Infant are not Baltimore City Residents
- Mother did not give birth to infant at Sinai Hospital in Baltimore, MD beginning approximately July 15, 2019
- Mother does not speak English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UMaryland
Baltimore, Maryland, 21201
Sinai Hospital
Baltimore, Maryland, 21215
About this study
The purpose of the current study is to evaluate the effects on early child development of early community services, including a brief nurse home visiting program. Investigators hypothesize that nurse home visiting program participants will be significantly different than non- nurse home visiting program participants on the following child and family outcomes: (a) (reduced) infant emergency room use and overnight hospital stays; (b) (increased) family use of community resources and (higher quality) child care; (c) (increased) maternal wellbeing; and (d) (increased) quality of the home environment, including home safety and supportive parenting by both parents. The study will also explore long-term differences between the nurse home visiting program recipients and non-recipients in (a) rates of official investigations for child maltreatment and (b) two indicators of early educational achievement: kindergarten readiness scores and rates of kindergarten attendance.
Read the detailed description
The purpose of the current study is to evaluate the effects on child and family development of early community services, including a brief nurse home visiting program. The proposed study will be conducted in partnership with the brief nurse home visiting program and Sinai Hospital, both located in Baltimore, MD. For the purposes of this study, Sinai Hospital will serve as the community/catchment area. Nurse home visitors enroll new mothers into the nurse home visiting program while they are still in the hospital/maternity ward. When the current study officially begins, nurse home visitors will recruit new mothers into the nurse home visiting program every other day only (on odd dates). Research staff will recruit all Baltimore City residents who give birth at Sinai Hospital, regardless of odd/even birth date, while they are still in the hospital/maternity ward.
- Conditions
- Child Development
- Being tested
- Nurse Home Visiting Program
- Keywords
- Nurse Home Visiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Home Visiting ProgramOther
Brief nurse home visiting program
| Study group | Role | What they receive |
|---|---|---|
| Nurse Home Visiting Group | Experimental | This group will be offered services from the nurse home visiting program. Receives: Other: Nurse Home Visiting Program |
| Non-intervention Group | No intervention | This group will not be offered services from the nurse home visiting program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study-specific Structured Maternal Report Interview on Infant Emergency Room Use
maternal report of infant emergency room use during study-specific structured interview, i.e.: Since you came home from the hospital after birth, has the baby had to go to the emergency room or emergency department for an illness, injury, or emergency?
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Data Collection From Records on Infant Emergency Room Use
records from Sinai Hospital and/or the Maryland Department of Health indicating number of emergency room visits
Measured: Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination
Study-specific Structured Maternal Report Interview on Number of Infant Overnight Hospital Stays
maternal report of number of infant overnight hospital stays during study-specific structured interview, i.e.: Since you came home from the hospital after birth, has the baby stayed overnight in the hospital for an illness, injury, or emergency? If yes, how many times?
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Data Collection From Records on Infant Overnight Hospital Stays
records from Sinai Hospital and/or the Maryland Department of Health indicating number of overnight hospital stays
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Study-specific Structured Maternal Report Interview on Family Use of Community Resources
Mothers were asked if they use the following services (yes/no): Food Stamps, Special Supplemental Nutrition Program for Women, Infants and Children (WIC), Supplemental Security Income (SSI), Work First- Family Cash Assistance, Medicaid (for the mother) or State Children's Health Insurance Program (S-CHIP) for child, Private health insurance, Job seeking assistance, Transportation assistance, Shelter/housing assistance, Food assistance, Clothing assistance, Furniture assistance, Heating/cooling assistance, Family planning clinic, Breastfeeding support, Mental health counseling, Substance use support, Couples counseling or domestic violence help, Veterans Affairs, Child Protective Services (CPS), Faith-based services, Maryland Family Network, The ARC of Maryland (for disabilities), B'more for Healthy Babies (services to prevent infant mortality), child care subsidy service, child care center or home based child care with other children or individual child care provider, Other
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Mothers were asked if they use the following services (yes/no): Food Stamps, Special Supplemental Nutrition Program for Women, Infants and Children (WIC), Supplemental Security Income (SSI), Work First- Family Cash Assistance, Medicaid (for the mother) or State Children's Health Insurance Program (S-CHIP) for child, Private health insurance, Job seeking assistance, Transportation assistance, Shelter/housing assistance, Food assistance, Clothing assistance, Furniture assistance, Heating/cooling assistance, Family planning clinic, Breastfeeding support, Mental health counseling, Substance use support, Couples counseling or domestic violence help, Veterans Affairs, Child Protective Services (CPS), Faith-based services, Maryland Family Network, The ARC of Maryland (for disabilities), B'more for Healthy Babies (services to prevent infant mortality), child care subsidy service, child care center or home based child care with other children or individual child care provider, Other
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Maternal Wellbeing as Assessed Using the Parenting Stress Index
During the study-specific structured interview, maternal stress was measured using the Parenting Stress Index-Short Form (PSI-SF), which includes three subscales-Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child, each containing 12 items. Mothers rated each of the 36 items on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Subscales are summed to compute a total score. The possible range is 36-180. Higher raw scores generally indicate higher levels of stress.
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Maternal Social Support as Assessed Using The Social Provisions Scale
Maternal social support was assessed using The Social Provisions Scale during study-specific structured interview. Mothers were asked to think about their current relationships and rate 24 statements on a scale of 1 (strongly disagree) to 4 (strongly agree). The possible total range is 12-48, with higher scores indicating higher levels of social support.
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Maternal Wellbeing as Assessed Using the Edinburgh Postpartum Depression Scale
maternal wellbeing as assessed using Edinburgh Postpartum Depression Scale (EPDS) during study-specific structured interview
The possible range for the EPDS is 0-30, with higher scores indicating more depressive symptoms. Scores greater than or equal to 13 indicate possible clinical depression.
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Maternal Wellbeing as Assessed Using the Generalized Anxiety Disorder (GAD-7)
During the study-specific structured interview, maternal well-being was measured using the Generalized Anxiety Disorder (GAD-7). Mothers were asked seven questions about how often they have been bothered by various problems, on a scale from 0 (not at all) to 3 (nearly every day). If they checked off any problems, they were additionally asked how difficult the problems have made it for them to do work, take care of things, or get along with others, on a scale from 0 (not difficult at all) to 3 (nearly every day).The possible range is a total score of 0-24, with higher scores indicating greater anxiety.
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
maternal wellbeing as assessed using study-specific structured interview, i.e.: Are you or your partner using any form of contraception or birth control at this time? Since you came home from the hospital after birth, have you had to go to your doctor or a health clinic, to the emergency room or emergency department, or stayed overnight in the hospital for illness/injury/emergency? Did you complete your 6-week post-partum check-up? Do you currently have any kind of chronic health conditions? If yes, are you under the regular care of a doctor to help manage this condition? What type of health care provider do you regularly see? In general, how do you pay for your health care? If you were sick and you wanted to be seen by a doctor, where would you go for care?
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Home Safety as Assessed Using H.O.M.E.
The Home Observation for Measurement of Environment (HOME) Inventory is an observational instrument of 45 items that measures a child's home environment, including the emotional and verbal responsivity of the mother, acceptance of the child, organization of the environment, provision of appropriate play materials, maternal involvement with the child, and variety in daily stimulation.
Measured: Planned collection: at/around the time infant turned 6 months old; As this is an in-home observational measure only and all in-home data collection was halted due to COVID-related precautions, we do not have data for the H.O.M.E.
Home Quality as Assessed Using H.O.M.E.
home quality as assessed using H.O.M.E. during study-specific structured interview
Measured: Planned collection: at/around the time infant turned 6 months old; As this is an in-home measure only and all in-home data collection was halted due to COVID-related precautions, we do not have data for the H.O.M.E.
Study-specific Structured Maternal Report Interview on Father's Supportive Parenting
maternal report of father's supportive parenting during study-specific structured interview, i.e.: How frequently does the father/partner (with/to the baby): Play games? Sing songs or nursery rhymes? Read stories? Tell stories? Play inside with toys? Take the baby to visit relatives? Helps the baby get dressed? Feeds the baby? Hug or show physical affection to the baby? Put the baby to bed? How often does he look after the baby? How often does he run errands for you? How often does he fix things around your home, paint, or help make it look nicer in other ways? How often does he take the baby places the baby needs to go? How often does your child's father buy the following items: clothes, toys, medicine, child care items, food or formula, anything else?
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Parenting Indicators (Discipline)
4 items to measure parental use of discipline (yes/no), type of physical punishment used (spank/tap)
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Study-specific Structured Maternal Report Interview on Quality Rating of Child's Care Center of Child Care, According to the EXCELS Rating System
maternal report of quality of child care during study-specific structured interview, according to the EXCELS rating system. EXCELS is the state's child care quality rating system for all licensed family and center-based child care providers in Maryland. Programs are rated on a 1 to 5 scale according to multiple quality indicators, including developmentally appropriate learning and practice, accreditation and rating scales, licensing and compliance, staff qualifications and professional development, administrative policies, etc. Higher numbers reflect higher overall quality of the child care program.
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Study-specific Structured Maternal Report Interview on Infant Immunizations
maternal report of infant being up to date on immunizations during study-specific structured interview, i.e. "Is the baby up to date on his/her immunizations?" (yes/no)
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Study-specific Structured Maternal Report Interview on Infant Well-baby Visits
maternal report of infant having their well-baby visit during study-specific structured interview, i.e. "When was the last time you took the baby to see the doctor for a general examination (also known as a "well-baby visit')?" They were asked to select from the following options: within the last month, within the last three months, more than three months ago, I don't remember, I don't take my baby to the doctor for general examinations
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Study-specific Structured Maternal Report Interview on the Number of Community Resources Family Uses
maternal report of number of resources used during study-specific structured interview, i.e. a sum of all of the resources named in the interview
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Infant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health Status
infant wellbeing as assessed using study-specific structured interview, i.e.: Are you currently breastfeeding? In no about how old was baby when you stopped breastfeeding? Does baby have a regular bedtime? Does baby have a regular bedtime routine? In which one position do you most often lay your baby down to sleep now? How often does baby sleep in the same bed with you or anyone else? Does anyone who lives in your home smoke cigarettes, cigars, pipes, or e-cigarettes anywhere in inside your home? Does your baby have a healthcare provider whom s/he sees regularly? If baby was sick and you wanted him/her to be seen by a doctor, where would you take baby for care? In general, how do you pay for your baby's health care?
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Secondary outcomes (5)
Data Collection From Records of Rates of Official Investigations for Child Maltreatment
records from the Maryland Department of Human Services
Measured: Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination
Maternal Wellbeing as Assessed Using the Adult Attachment Style (AAS)
In the AAS, mothers selected one of three brief narrative descriptions, each of which corresponds to an adult attachment style. i.e. : 1) somewhat uncomfortable being close to and trusting others …(avoidant); 2) relatively easy to get close to others and comfortable depending on them.... (secure); 3) others are reluctant to get as close as I would like (anxious)....
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Maternal Wellbeing as Assessed Using the Adverse Childhood Experiences (ACEs)
maternal wellbeing as assessed using the Adverse Childhood Experiences (ACEs) during study-specific structured interview. The range is 0-10 ACEs total.
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Neighborhood Quality as Assessed Using The Neighborhood Collective Efficacy
neighborhood quality as assessed using The Neighborhood Collective Efficacy during study-specific structured interview
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Study-specific Structured Maternal Report Interview on Transportation
study-specific structured maternal report interview on transportation. Participants were asked the following questions: Does anyone in your household own a working car, van, or truck? How do you usually get around, for example if you need to go somewhere like to work, the store or the doctor's office? How easy is it for you to get where you need to go (work, store, doctor's office, etc.) by personal car?
Measured: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start18 Jul 2019
- Primary completion29 Sep 2020
- Study completion19 Jul 2021
Why it stopped: The COVID-19 pandemic halted research activities at the collaborating hospital.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Participant
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- LifeBridge Health
- Responsible party
- Principal investigator, Lisa Berlin, University of Maryland, Baltimore
- Investigators
- Lisa J Berlin, PhD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019977
- Sponsor's protocol ID
- HP-00076256
- Status last verified
- Jan 2025
- First submitted
- 12 Jul 2019
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual results will not be shared with participants nor their primary care physician. Study results will be shared in aggregate in the form of a one-page infographic available to study participants at their request. De-identified and masked study findings will be shared with the Sinai Hospital research team and with other community service providers upon request. Finally, aggregate findings will be reported in scholarly journals.
Publications
Dodge 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 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 24354833
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Community Services on Child and Family Development
- ClinicalTrials.gov ID
- NCT04019977
- Acronym / sponsor ID
- HP-00076256
- Conditions
- Child Development
- Keywords
- Nurse Home Visiting
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The COVID-19 pandemic halted research activities at the collaborating hospital.
- Enrolment
- 277 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- LifeBridge Health
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 19 Jul 2021 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Posted 21 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the current study is to evaluate the effects on early child development of early community services, including a brief nurse home visiting program. Investigators hypothesize that nurse home visiting program participants will be significantly different than non- nurse home visiting program participants on the following child and family outcomes: (a) (reduced) infant emergency room use and overnight hospital stays; (b) (increased) family use of community resources and (higher quality) child care; (c) (increased) maternal wellbeing; and (d) (increased) quality of the home environment, including home safety and supportive parenting by both parents. The study will also explore long-term differences between the nurse home visiting program recipients and non-recipients in (a) rates of official investigations for child maltreatment and (b) two indicators of early educational achievement: kindergarten readiness scores and rates of kindergarten attendance.
Detailed description
The purpose of the current study is to evaluate the effects on child and family development of early community services, including a brief nurse home visiting program. The proposed study will be conducted in partnership with the brief nurse home visiting program and Sinai Hospital, both located in Baltimore, MD. For the purposes of this study, Sinai Hospital will serve as the community/catchment area. Nurse home visitors enroll new mothers into the nurse home visiting program while they are still in the hospital/maternity ward. When the current study officially begins, nurse home visitors will recruit new mothers into the nurse home visiting program every other day only (on odd dates). Research staff will recruit all Baltimore City residents who give birth at Sinai Hospital, regardless of odd/even birth date, while they are still in the hospital/maternity ward.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse Home Visiting Group | Experimental | Other: Nurse Home Visiting ProgramThis group will be offered services from the nurse home visiting program. |
| Non-intervention Group | No intervention | –This group will not be offered services from the nurse home visiting program. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Mother and Infant are Baltimore City Residents
- Mother gave birth to infant at Sinai Hospital in Baltimore, MD beginning approximately July 15, 2019
- Mother speaks English
Key exclusion criteria (3 listed)
- Mother and Infant are not Baltimore City Residents
- Mother did not give birth to infant at Sinai Hospital in Baltimore, MD beginning approximately July 15, 2019
- Mother does not speak English
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 |
|---|---|---|
| Nurse Home Visiting ProgramBrief nurse home visiting program | Other | Nurse Home Visiting Group |
Primary outcome
Study-specific Structured Maternal Report Interview on Infant Emergency Room Use
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
maternal report of infant emergency room use during study-specific structured interview, i.e.: Since you came home from the hospital after birth, has the baby had to go to the emergency room or emergency department for an illness, injury, or emergency?
Data Collection From Records on Infant Emergency Room Use
Time frame: Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination
records from Sinai Hospital and/or the Maryland Department of Health indicating number of emergency room visits
Study-specific Structured Maternal Report Interview on Number of Infant Overnight Hospital Stays
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
maternal report of number of infant overnight hospital stays during study-specific structured interview, i.e.: Since you came home from the hospital after birth, has the baby stayed overnight in the hospital for an illness, injury, or emergency? If yes, how many times?
Data Collection From Records on Infant Overnight Hospital Stays
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
records from Sinai Hospital and/or the Maryland Department of Health indicating number of overnight hospital stays
Study-specific Structured Maternal Report Interview on Family Use of Community Resources
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Mothers were asked if they use the following services (yes/no): Food Stamps, Special Supplemental Nutrition Program for Women, Infants and Children (WIC), Supplemental Security Income (SSI), Work First- Family Cash Assistance, Medicaid (for the mother) or State Children's Health Insurance Program (S-CHIP) for child, Private health insurance, Job seeking assistance, Transportation assistance, Shelter/housing assistance, Food assistance, Clothing assistance, Furniture assistance, Heating/cooling assistance, Family planning clinic, Breastfeeding support, Mental health counseling, Substance use support, Couples counseling or domestic violence help, Veterans Affairs, Child Protective Services (CPS), Faith-based services, Maryland Family Network, The ARC of Maryland (for disabilities), B'more for Healthy Babies (services to prevent infant mortality), child care subsidy service, child care center or home based child care with other children or individual child care provider, Other
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Mothers were asked if they use the following services (yes/no): Food Stamps, Special Supplemental Nutrition Program for Women, Infants and Children (WIC), Supplemental Security Income (SSI), Work First- Family Cash Assistance, Medicaid (for the mother) or State Children's Health Insurance Program (S-CHIP) for child, Private health insurance, Job seeking assistance, Transportation assistance, Shelter/housing assistance, Food assistance, Clothing assistance, Furniture assistance, Heating/cooling assistance, Family planning clinic, Breastfeeding support, Mental health counseling, Substance use support, Couples counseling or domestic violence help, Veterans Affairs, Child Protective Services (CPS), Faith-based services, Maryland Family Network, The ARC of Maryland (for disabilities), B'more for Healthy Babies (services to prevent infant mortality), child care subsidy service, child care center or home based child care with other children or individual child care provider, Other
Maternal Wellbeing as Assessed Using the Parenting Stress Index
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
During the study-specific structured interview, maternal stress was measured using the Parenting Stress Index-Short Form (PSI-SF), which includes three subscales-Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child, each containing 12 items. Mothers rated each of the 36 items on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Subscales are summed to compute a total score. The possible range is 36-180. Higher raw scores generally indicate higher levels of stress.
Maternal Social Support as Assessed Using The Social Provisions Scale
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Maternal social support was assessed using The Social Provisions Scale during study-specific structured interview. Mothers were asked to think about their current relationships and rate 24 statements on a scale of 1 (strongly disagree) to 4 (strongly agree). The possible total range is 12-48, with higher scores indicating higher levels of social support.
Maternal Wellbeing as Assessed Using the Edinburgh Postpartum Depression Scale
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
maternal wellbeing as assessed using Edinburgh Postpartum Depression Scale (EPDS) during study-specific structured interview The possible range for the EPDS is 0-30, with higher scores indicating more depressive symptoms. Scores greater than or equal to 13 indicate possible clinical depression.
Maternal Wellbeing as Assessed Using the Generalized Anxiety Disorder (GAD-7)
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
During the study-specific structured interview, maternal well-being was measured using the Generalized Anxiety Disorder (GAD-7). Mothers were asked seven questions about how often they have been bothered by various problems, on a scale from 0 (not at all) to 3 (nearly every day). If they checked off any problems, they were additionally asked how difficult the problems have made it for them to do work, take care of things, or get along with others, on a scale from 0 (not difficult at all) to 3 (nearly every day).The possible range is a total score of 0-24, with higher scores indicating greater anxiety.
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
maternal wellbeing as assessed using study-specific structured interview, i.e.: Are you or your partner using any form of contraception or birth control at this time? Since you came home from the hospital after birth, have you had to go to your doctor or a health clinic, to the emergency room or emergency department, or stayed overnight in the hospital for illness/injury/emergency? Did you complete your 6-week post-partum check-up? Do you currently have any kind of chronic health conditions? If yes, are you under the regular care of a doctor to help manage this condition? What type of health care provider do you regularly see? In general, how do you pay for your health care? If you were sick and you wanted to be seen by a doctor, where would you go for care?
Home Safety as Assessed Using H.O.M.E.
Time frame: Planned collection: at/around the time infant turned 6 months old; As this is an in-home observational measure only and all in-home data collection was halted due to COVID-related precautions, we do not have data for the H.O.M.E.
The Home Observation for Measurement of Environment (HOME) Inventory is an observational instrument of 45 items that measures a child's home environment, including the emotional and verbal responsivity of the mother, acceptance of the child, organization of the environment, provision of appropriate play materials, maternal involvement with the child, and variety in daily stimulation.
Home Quality as Assessed Using H.O.M.E.
Time frame: Planned collection: at/around the time infant turned 6 months old; As this is an in-home measure only and all in-home data collection was halted due to COVID-related precautions, we do not have data for the H.O.M.E.
home quality as assessed using H.O.M.E. during study-specific structured interview
Study-specific Structured Maternal Report Interview on Father's Supportive Parenting
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
maternal report of father's supportive parenting during study-specific structured interview, i.e.: How frequently does the father/partner (with/to the baby): Play games? Sing songs or nursery rhymes? Read stories? Tell stories? Play inside with toys? Take the baby to visit relatives? Helps the baby get dressed? Feeds the baby? Hug or show physical affection to the baby? Put the baby to bed? How often does he look after the baby? How often does he run errands for you? How often does he fix things around your home, paint, or help make it look nicer in other ways? How often does he take the baby places the baby needs to go? How often does your child's father buy the following items: clothes, toys, medicine, child care items, food or formula, anything else?
Parenting Indicators (Discipline)
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
4 items to measure parental use of discipline (yes/no), type of physical punishment used (spank/tap)
Study-specific Structured Maternal Report Interview on Quality Rating of Child's Care Center of Child Care, According to the EXCELS Rating System
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
maternal report of quality of child care during study-specific structured interview, according to the EXCELS rating system. EXCELS is the state's child care quality rating system for all licensed family and center-based child care providers in Maryland. Programs are rated on a 1 to 5 scale according to multiple quality indicators, including developmentally appropriate learning and practice, accreditation and rating scales, licensing and compliance, staff qualifications and professional development, administrative policies, etc. Higher numbers reflect higher overall quality of the child care program.
Study-specific Structured Maternal Report Interview on Infant Immunizations
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
maternal report of infant being up to date on immunizations during study-specific structured interview, i.e. "Is the baby up to date on his/her immunizations?" (yes/no)
Study-specific Structured Maternal Report Interview on Infant Well-baby Visits
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
maternal report of infant having their well-baby visit during study-specific structured interview, i.e. "When was the last time you took the baby to see the doctor for a general examination (also known as a "well-baby visit')?" They were asked to select from the following options: within the last month, within the last three months, more than three months ago, I don't remember, I don't take my baby to the doctor for general examinations
Study-specific Structured Maternal Report Interview on the Number of Community Resources Family Uses
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
maternal report of number of resources used during study-specific structured interview, i.e. a sum of all of the resources named in the interview
Infant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health Status
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
infant wellbeing as assessed using study-specific structured interview, i.e.: Are you currently breastfeeding? In no about how old was baby when you stopped breastfeeding? Does baby have a regular bedtime? Does baby have a regular bedtime routine? In which one position do you most often lay your baby down to sleep now? How often does baby sleep in the same bed with you or anyone else? Does anyone who lives in your home smoke cigarettes, cigars, pipes, or e-cigarettes anywhere in inside your home? Does your baby have a healthcare provider whom s/he sees regularly? If baby was sick and you wanted him/her to be seen by a doctor, where would you take baby for care? In general, how do you pay for your baby's health care?
5 secondary outcomes
Data Collection From Records of Rates of Official Investigations for Child Maltreatment
Time frame: Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination
Maternal Wellbeing as Assessed Using the Adult Attachment Style (AAS)
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Maternal Wellbeing as Assessed Using the Adverse Childhood Experiences (ACEs)
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Neighborhood Quality as Assessed Using The Neighborhood Collective Efficacy
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Study-specific Structured Maternal Report Interview on Transportation
Time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: 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.
- Background: 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.
- Individual participant dataSharing planned: No. Individual results will not be shared with participants nor their primary care physician. Study results will be shared in aggregate in the form of a one-page infographic available to study participants at their request. De-identified and masked study findings will be shared with the Sinai Hospital research team and with other community service providers upon request. Finally, aggregate findings will be reported in scholarly journals.
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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.
Lisa J Berlin, PhD principal investigator
University of Maryland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Home Visiting Program in people with Child Development, run by University of Maryland, Baltimore at 2 sites 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: stopped early, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Study-specific Structured Maternal Report Interview on Infant Emergency Room Use (time frame: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m). The study lists 20 primary outcomes in all. 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 NCT04019977, 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 21 Feb 2025.