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The COVID-19 pandemic halted research activities at the collaborating hospital.
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| Name | Class |
|---|---|
| LifeBridge Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse Home Visiting Group | Experimental | This 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse Home Visiting Program | Other | Brief nurse home visiting program |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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? | 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 | 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? | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Data Collection From Records of Rates of Official Investigations for Child Maltreatment | records from the Maryland Department of Human Services | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Data Collection From Records of Early Educational Achievement: Kindergarten Readiness Scores, Exploratory | records from the Maryland State Department of Education, exploratory | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa J Berlin, PhD | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMaryland | Baltimore | Maryland | 21201 | United States | ||
| Sinai Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24187116 | Background | 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. | |
| 24354833 | Background | Dodge KA, Goodman WB, Murphy RA, O'Donnell K, Sato J, Guptill S. Implementation and randomized controlled trial evaluation of universal postnatal nurse home visiting. Am J Public Health. 2014 Feb;104 Suppl 1(0 1):S136-43. doi: 10.2105/AJPH.2013.301361. Epub 2013 Dec 19. |
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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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Due to the COVID-19 pandemic and the participating hospital halting research activities, recruitment abruptly stopped in March, 2020, and participants in the treatment group did not receive the intervention. Because randomization and service delivery failed to occur, results are reported as an aggregate of all 152 participants that completed an interview.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Completed Interview | Participants who gave birth at Hospital, were City residents, enrolled in the study and completed the interview. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Enrolled participants who completed the cross-sectional interview
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| ID | Title | Description |
|---|---|---|
| BG000 | Completed Interview | The mothers enrolled in the study and completed the interview. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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? | Those who completed the interview | Posted | Count of Participants | Participants | 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 |
|
Adverse events were not assessed in this study
Adverse events were not assessed in this study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Adverse Events Were Monitored | No adverse events were monitored | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Berlin | University of Maryland School of Social Work | 410 706 6392 | lberlin@ssw.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 24, 2020 | Jan 27, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 24, 2020 | Jan 27, 2025 | SAP_001.pdf |
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As described above, the nurse home visiting program is being provided on a random-assignment basis according to child birthdate. Nurse home visitors will enroll new mothers into the nurse home visiting program every other day only (on odd dates). The new mothers who give birth on an even date will not be offered the nurse home visiting program. They will be considered the "control" group and are expected to access community services as they normally would.
| 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 | 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 | 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. | 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. | 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. | 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. | 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? | 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. | 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 | 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? | 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) | 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. | 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) | 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 | 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 | 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? | 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 |
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).... |
| 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. | 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 | 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? | 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 the Maryland State Department of Education, exploratory |
| Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination |
| Baltimore |
| Maryland |
| 21215 |
| United States |
| years |
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| Sex: Female, Male | Interview | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Interview | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | 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 | Due to COVID-19, this study ended prematurely, in March 2020. No follow-up interview was conducted. | Posted | Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination |
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| Primary | 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? | Posted | Count of Participants | Participants | 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 |
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| Primary | 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 | Posted | Mean | Standard Deviation | number of overnight hospital stays | 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 |
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| Primary | 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 | Posted | Mean | Standard Deviation | Number of resources used | 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 |
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| Primary | 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 | Total n's may be less than 152 due to missing data. | Posted | Count of Participants | Participants | 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 |
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| Primary | 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. | 3 participants did not respond to this question | Posted | Mean | Standard Deviation | total score on a scale | 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 |
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| Primary | 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. | Posted | Mean | Standard Deviation | total score on a scale | 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 |
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| Primary | 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. | N does not equal 152 due to missing data. | Posted | Mean | Standard Deviation | units on a scale | 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 |
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| Primary | 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. | Posted | Mean | Standard Deviation | total score on a scale | 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 |
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| Primary | 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? | Participants did not respond to all questions and each row represents another outcome related to the main outcome. | Posted | Count of Participants | Participants | 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 |
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| Primary | 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. | Due to COVID-19 precautions, we did not collect these data. | Posted | 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. |
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| Primary | Home Quality as Assessed Using H.O.M.E. | home quality as assessed using H.O.M.E. during study-specific structured interview | Due to COVID-19 precautions, we did not collect these data. | Posted | 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. |
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| Primary | 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? | 42 mothers did not respond | Posted | Mean | Standard Deviation | units on a scale | 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 |
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| Primary | Parenting Indicators (Discipline) | 4 items to measure parental use of discipline (yes/no), type of physical punishment used (spank/tap) | N's may not add up to 152 due to missing data | Posted | Count of Participants | Participants | 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 |
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| Primary | 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. | Only those who indicated their child is in family day care or a child care center were asked to complete this question. N's do not add to 17 due to missing data. | Posted | Count of Participants | Participants | 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 |
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| Primary | 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) | Posted | Count of Participants | Participants | 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 |
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| Primary | 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 | N's may not add to 152 due to missing data. | Posted | Count of Participants | Participants | 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 |
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| Primary | 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 | Posted | Mean | Standard Deviation | total number of resources used | 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 |
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| Primary | 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? | Multiple outcomes are measured for infant wellbeing. Therefore, not all outcomes add up to N = 152 | Posted | Count of Participants | Participants | 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 |
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| Secondary | Data Collection From Records of Rates of Official Investigations for Child Maltreatment | records from the Maryland Department of Human Services | Due to COVID-19, this study ended prematurely, in March 2020. No follow-up interview nor record scanning was conducted. | Posted | Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination |
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| Secondary | 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).... | 151 participants responded to this scale | Posted | Count of Participants | Participants | 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 |
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| Secondary | 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. | Total number of ACE's (0 - 10) | Posted | Mean | Standard Deviation | Total ACEs | 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 |
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| Secondary | Neighborhood Quality as Assessed Using The Neighborhood Collective Efficacy | neighborhood quality as assessed using The Neighborhood Collective Efficacy during study-specific structured interview | (possible range 4-16) | Posted | Mean | Standard Deviation | units on a scale | 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 |
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| Secondary | 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? | N's may not add to 152 due to missing data. | Posted | Count of Participants | Participants | 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 |
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| Other Pre-specified | Data Collection From Records of Early Educational Achievement: Kindergarten Readiness Scores, Exploratory | records from the Maryland State Department of Education, exploratory | We did not collect these data. | Posted | Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination |
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| Other Pre-specified | Data Collection From Records of Early Educational Achievement: Rates of Kindergarten Attendance, Exploratory | records from the Maryland State Department of Education, exploratory | We did not collect these data. | Posted | Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
Not provided
Not provided
| WIC |
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| SSI |
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| TCA |
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| Medicaid |
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| SCHIP |
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| Private health insurance |
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| Job services |
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| Transportation assistance |
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| Shelter assistance |
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| Housing assistance |
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| Food bank |
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| Clothing assistance |
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| Furniture assistance |
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| Heating/cooling assistance |
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| Family planning clinic |
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| Refused or N/A |
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| Completed maternal 6-week post-partum check-up |
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| Chronic health conditions such as high blood pressure or diabetes |
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| Sees a health care provider regularly |
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| Use of contraception or birth control at this time |
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| Mother ER visits |
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| Hospital overnight for mother illness, injury, or emergency |
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| If sick and wanted to be seen by a doctor, mother would go to...PCP |
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| If sick and wanted to be seen by a doctor, mother would go to...health care clinic/urgent care |
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| If sick and wanted to be seen by a doctor, mother would go to...emergency room |
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| If sick and wanted to be seen by a doctor, mother would go to...(Other) |
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| Payment for health care: out of pocket |
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| Payment for health care: health insurance |
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| Payment for health care: Medicaid |
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| Payment for health care: Other |
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| If yes, type of physical punishment used: spank/pop or slap |
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| If yes, type of physical punishment used: Tap |
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| Title | Measurements |
|---|---|
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| EXCELS Level 4 |
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| EXCELS Level 5 |
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| Level unknown |
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| Title | Measurements |
|---|---|
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| Infant has a regular bedtime |
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| Infant has regular bedtime routine |
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| Smoking in household |
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| Does the baby have a healthcare provider |
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| Forms of transportation used: own (family) car |
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| Forms of transportation used: other (family) person's car |
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| Forms of transportation used: own (family) car/taxi or rideshare |
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| Forms of transportation used: own (family) car/public transportation |
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| Forms of transportation used: own (family) car/walk |
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| Forms of transportation used: Other person's car |
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| Forms of transportation used: walk/taxi or rideshare |
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| Forms of transportation used: other person's car/public transportation |
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| Forms of transportation used: other person's car/public transit/CASA worker |
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| Forms of transportation used: taxi/rideshare |
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| Forms of transportation used: Public transportation |
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| How easy is it to get where you need to go? -- Very easy |
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| How easy is it to get where you need to go?- Somewhat easy |
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| How easy is it to get where you need to go?-- Moderately easy/difficult |
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| How easy is it to get where you need to go?-- extremely difficult |
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