An interventional study of Nurse Home Visiting Program in Child Development, sponsored by University of Maryland, Baltimore. Terminated at 2 sites in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Prevention
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.
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.
University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group will be offered services from the nurse home visiting program.
Other: Nurse Home Visiting Program
This group will not be offered services from the nurse home visiting program.
Brief nurse home visiting program
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?
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
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
Time frame: 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?
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
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
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 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
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 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
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 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.
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 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.
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 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.
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 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.
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 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?
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
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.
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.
Home Quality as Assessed Using H.O.M.E.
home quality as assessed using H.O.M.E. during study-specific structured interview
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.
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?
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
Parenting Indicators (Discipline)
4 items to measure parental use of discipline (yes/no), type of physical punishment used (spank/tap)
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 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.
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 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)
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 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
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 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
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 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?
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
Data Collection From Records of Rates of Official Investigations for Child Maltreatment
records from the Maryland Department of Human Services
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)
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)....
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)
maternal wellbeing as assessed using the Adverse Childhood Experiences (ACEs) during study-specific structured interview. The range is 0-10 ACEs total.
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
neighborhood quality as assessed using The Neighborhood Collective Efficacy during study-specific structured interview
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
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?
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
Data Collection From Records of Early Educational Achievement: Kindergarten Readiness Scores, Exploratory
records from the Maryland State Department of Education, exploratory
Time frame: Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination
Data Collection From Records of Early Educational Achievement: Rates of Kindergarten Attendance, Exploratory
records from the Maryland State Department of Education, exploratory
Time frame: Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination
From July 2019-March 2020, FCM staff recruited the treatment group: City residents who gave birth at a local hospital on odd dates. Simultaneously, research staff invited all city residents who gave birth at this Hospital as the control group. However, due to COVID-19, participants in the treatment group did not receive nurse visits as planned and recruitment abruptly stopped in March 2020.
| Milestone | Completed Interview |
|---|---|
| Started | 152 |
| Completed | 152 |
| Not completed | 0 |
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?
| Participants | Infant ER Visit |
|---|---|
| Yes | 20 |
| No | 132 |
records from Sinai Hospital and/or the Maryland Department of Health indicating number of emergency room visits
| Measure | Infant ER Visit |
|---|---|
| Yes | — |
| No | — |
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?
| Participants | Infant ER Visit |
|---|---|
| Yes | 7 |
| No | 145 |
records from Sinai Hospital and/or the Maryland Department of Health indicating number of overnight hospital stays
| number of overnight hospital stays | Completed Interview |
|---|---|
| Data Collection From Records on Infant Overnight Hospital Stays | 0.05 ± 0.21 |
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
| Number of resources used | Completed Interview |
|---|---|
| Study-specific Structured Maternal Report Interview on Family Use of Community Resources | 3.99 ± 2.24 |
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
| Participants | Completed Interview |
|---|---|
| SNAP — yes | 61 |
| SNAP — no | 91 |
| WIC — yes | 89 |
| WIC — no | 63 |
| SSI — yes | 2 |
| SSI — no | 150 |
| TCA — yes | 17 |
| TCA — no | 135 |
| Medicaid — yes | 75 |
| Medicaid — no | 77 |
| SCHIP — yes | 96 |
| SCHIP — no | 56 |
| Private health insurance — yes | 74 |
| Private health insurance — no | 78 |
| Job services — yes | 7 |
| Job services — no | 145 |
| Transportation assistance — yes | 4 |
| Transportation assistance — no | 148 |
| Shelter assistance — yes | 0 |
| Shelter assistance — no | 152 |
| Housing assistance — yes | 3 |
| Housing assistance — no | 149 |
| Food bank — yes | 9 |
| Food bank — no | 142 |
| Clothing assistance — yes | 3 |
| Clothing assistance — no | 149 |
| Furniture assistance — yes | 0 |
| Furniture assistance — no | 152 |
| Heating/cooling assistance — yes | 2 |
| Heating/cooling assistance — no | 150 |
| Family planning clinic — yes | 3 |
| Family planning clinic — no | 147 |
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.
| total score on a scale | Completed Interview |
|---|---|
| Maternal Wellbeing as Assessed Using the Parenting Stress Index | 53.56 ± 19.59 |
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.
| total score on a scale | Completed Interview |
|---|---|
| Maternal Social Support as Assessed Using The Social Provisions Scale | 44.26 ± 5.07 |
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.
| units on a scale | Completed Interview |
|---|---|
| Maternal Wellbeing as Assessed Using the Edinburgh Postpartum Depression Scale | 4.72 ± 3.93 |
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.
| total score on a scale | Completed Interview |
|---|---|
| Maternal Wellbeing as Assessed Using the Generalized Anxiety Disorder (GAD-7) | 4.01 ± 3.53 |
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?
| Participants | Maternal Wellbeing |
|---|---|
| Dr. or clinic visit(s) for mother illness, injury, or emergency — Yes | 51 |
| Dr. or clinic visit(s) for mother illness, injury, or emergency — No | 101 |
| Dr. or clinic visit(s) for mother illness, injury, or emergency — Refused or N/A | 0 |
| Completed maternal 6-week post-partum check-up — Yes | 142 |
| Completed maternal 6-week post-partum check-up — No | 10 |
| Completed maternal 6-week post-partum check-up — Refused or N/A | 0 |
| Chronic health conditions such as high blood pressure or diabetes — Yes | 21 |
| Chronic health conditions such as high blood pressure or diabetes — No | 130 |
| Chronic health conditions such as high blood pressure or diabetes — Refused or N/A | 0 |
| Sees a health care provider regularly — Yes | 125 |
| Sees a health care provider regularly — No | 27 |
| Sees a health care provider regularly — Refused or N/A | 0 |
| Use of contraception or birth control at this time — Yes | 100 |
| Use of contraception or birth control at this time — No | 44 |
| Use of contraception or birth control at this time — Refused or N/A | 6 |
| Mother ER visits — Yes | 24 |
| Mother ER visits — No | 128 |
| Mother ER visits — Refused or N/A | 0 |
| Hospital overnight for mother illness, injury, or emergency — Yes | 8 |
| Hospital overnight for mother illness, injury, or emergency — No | 144 |
| Hospital overnight for mother illness, injury, or emergency — Refused or N/A | 0 |
| If sick and wanted to be seen by a doctor, mother would go to...PCP — Yes | 109 |
| If sick and wanted to be seen by a doctor, mother would go to...PCP — No | 43 |
| If sick and wanted to be seen by a doctor, mother would go to...PCP — Refused or N/A | 0 |
| If sick and wanted to be seen by a doctor, mother would go to...health care clinic/urgent care — Yes | 27 |
| If sick and wanted to be seen by a doctor, mother would go to...health care clinic/urgent care — No | 125 |
| If sick and wanted to be seen by a doctor, mother would go to...health care clinic/urgent care — Refused or N/A | 0 |
| If sick and wanted to be seen by a doctor, mother would go to...emergency room — Yes | 10 |
| If sick and wanted to be seen by a doctor, mother would go to...emergency room — No | 142 |
| If sick and wanted to be seen by a doctor, mother would go to...emergency room — Refused or N/A | 0 |
| If sick and wanted to be seen by a doctor, mother would go to...(Other) — Yes | 6 |
| If sick and wanted to be seen by a doctor, mother would go to...(Other) — No | 146 |
| If sick and wanted to be seen by a doctor, mother would go to...(Other) — Refused or N/A | 0 |
| Payment for health care: out of pocket — Yes | 2 |
| Payment for health care: out of pocket — No | 150 |
| Payment for health care: out of pocket — Refused or N/A | 0 |
| Payment for health care: health insurance — Yes | 78 |
| Payment for health care: health insurance — No | 74 |
| Payment for health care: health insurance — Refused or N/A | 0 |
| Payment for health care: Medicaid — Yes | 68 |
| Payment for health care: Medicaid — No | 84 |
| Payment for health care: Medicaid — Refused or N/A | 0 |
| Payment for health care: Other — Yes | 4 |
| Payment for health care: Other — No | 148 |
| Payment for health care: Other — Refused or N/A | 0 |
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.
No measurements were reported for this outcome.
home quality as assessed using H.O.M.E. during study-specific structured interview
No measurements were reported for this outcome.
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?
| units on a scale | Completed Interview |
|---|---|
| Study-specific Structured Maternal Report Interview on Father's Supportive Parenting | 20.94 ± 9.21 |
4 items to measure parental use of discipline (yes/no), type of physical punishment used (spank/tap)
| Participants | Completed Interview |
|---|---|
| Use of physical discipline — Yes | 2 |
| Use of physical discipline — No | 148 |
| If yes, type of physical punishment used: spank/pop or slap — Yes | 1 |
| If yes, type of physical punishment used: spank/pop or slap — No | 1 |
| If yes, type of physical punishment used: Tap — Yes | 1 |
| If yes, type of physical punishment used: Tap — No | 1 |
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.
| Participants | Completed Interview |
|---|---|
| EXCELS Level 1 | 0 |
| EXCELS Level 2 | 0 |
| EXCELS Level 3 | 0 |
| EXCELS Level 4 | 2 |
| EXCELS Level 5 | 1 |
| Level unknown | 12 |
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)
| Participants | Completed Interview |
|---|---|
| Yes | 138 |
| No | 14 |
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
| Participants | Completed Interview |
|---|---|
| Within the last month | 72 |
| Within the last 3 months | 75 |
| More than 3 months ago | 5 |
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
| total number of resources used | Completed Interview |
|---|---|
| Study-specific Structured Maternal Report Interview on the Number of Community Resources Family Uses | 3.99 ± 2.24 |
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?
| Participants | Completed Interview |
|---|---|
| Currently breastfeeding — yes | 138 |
| Currently breastfeeding — no | 14 |
| Infant has a regular bedtime — yes | 124 |
| Infant has a regular bedtime — no | 27 |
| Infant has regular bedtime routine — yes | 138 |
| Infant has regular bedtime routine — no | 13 |
| Smoking in household — yes | 2 |
| Smoking in household — no | 150 |
| Does the baby have a healthcare provider — yes | 148 |
| Does the baby have a healthcare provider — no | 2 |
records from the Maryland Department of Human Services
No measurements were reported for this outcome.
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)....
| Participants | Completed Interview |
|---|---|
| Avoidant | 26 |
| Secure | 118 |
| Anxious | 7 |
maternal wellbeing as assessed using the Adverse Childhood Experiences (ACEs) during study-specific structured interview. The range is 0-10 ACEs total.
| Total ACEs | Completed Interview |
|---|---|
| Maternal Wellbeing as Assessed Using the Adverse Childhood Experiences (ACEs) | 1.5 ± 2.12 |
neighborhood quality as assessed using The Neighborhood Collective Efficacy during study-specific structured interview
| units on a scale | Completed Interview |
|---|---|
| Neighborhood Quality as Assessed Using The Neighborhood Collective Efficacy | 6.85 ± 2.96 |
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?
| Participants | Completed Interview |
|---|---|
| Does anyone in the household own a working car, van, truck? — Yes | 138 |
| Does anyone in the household own a working car, van, truck? — No | 12 |
| Forms of transportation used: own (family) car — Yes | 122 |
| Forms of transportation used: own (family) car — No | 30 |
| Forms of transportation used: other (family) person's car — Yes | 2 |
| Forms of transportation used: other (family) person's car — No | 150 |
| Forms of transportation used: own (family) car/taxi or rideshare — Yes | 4 |
| Forms of transportation used: own (family) car/taxi or rideshare — No | 148 |
| Forms of transportation used: own (family) car/public transportation — Yes | 2 |
| Forms of transportation used: own (family) car/public transportation — No | 150 |
| Forms of transportation used: own (family) car/walk — Yes | 2 |
| Forms of transportation used: own (family) car/walk — No | 150 |
| Forms of transportation used: Other person's car — Yes | 7 |
| Forms of transportation used: Other person's car — No | 145 |
| Forms of transportation used: walk/taxi or rideshare — Yes | 5 |
| Forms of transportation used: walk/taxi or rideshare — No | 147 |
| Forms of transportation used: other person's car/public transportation — Yes | 1 |
| Forms of transportation used: other person's car/public transportation — No | 151 |
| Forms of transportation used: other person's car/public transit/CASA worker — Yes | 1 |
| Forms of transportation used: other person's car/public transit/CASA worker — No | 151 |
| Forms of transportation used: taxi/rideshare — Yes | 3 |
| Forms of transportation used: taxi/rideshare — No | 149 |
| Forms of transportation used: Public transportation — Yes | 3 |
| Forms of transportation used: Public transportation — No | 149 |
| How easy is it to get where you need to go? -- Very easy — Yes | 125 |
| How easy is it to get where you need to go? -- Very easy — No | 27 |
| How easy is it to get where you need to go?- Somewhat easy — Yes | 20 |
| How easy is it to get where you need to go?- Somewhat easy — No | 132 |
| How easy is it to get where you need to go?-- Moderately easy/difficult — Yes | 5 |
| How easy is it to get where you need to go?-- Moderately easy/difficult — No | 147 |
| How easy is it to get where you need to go?-- extremely difficult — Yes | 2 |
| How easy is it to get where you need to go?-- extremely difficult — No | 150 |
records from the Maryland State Department of Education, exploratory
No measurements were reported for this outcome.
records from the Maryland State Department of Education, exploratory
No measurements were reported for this outcome.
Collected over Adverse events were not assessed in this study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Adverse Events Were Monitored | — | — | — |
Enrolled participants who completed the cross-sectional interview
| Age, Continuous(years) | Completed Interview |
|---|---|
| Mean | 29.87 (18 to 42) |
| Sex: Female, Male(Participants) | Completed Interview |
|---|---|
| Female | 152 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Completed Interview |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 146 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Completed Interview |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 71 |
| White | 71 |
| More than one race | 6 |
| Unknown or Not Reported | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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