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Effects of Early Community Services on Child and Family Development

Effects of Early Community Services on Child and Family Development

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04019977
Enrollment
277
Registered
2019-07-15
Start date
2019-07-18
Completion date
2021-07-19
Last updated
2025-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development

Keywords

Nurse Home Visiting

Brief summary

The purpose of the current study is to evaluate the effects on early child development of early community services, including a brief nurse home visiting program. Investigators hypothesize that nurse home visiting program participants will be significantly different than non- nurse home visiting program participants on the following child and family outcomes: (a) (reduced) infant emergency room use and overnight hospital stays; (b) (increased) family use of community resources and (higher quality) child care; (c) (increased) maternal wellbeing; and (d) (increased) quality of the home environment, including home safety and supportive parenting by both parents. The study will also explore long-term differences between the nurse home visiting program recipients and non-recipients in (a) rates of official investigations for child maltreatment and (b) two indicators of early educational achievement: kindergarten readiness scores and rates of kindergarten attendance.

Detailed description

The purpose of the current study is to evaluate the effects on child and family development of early community services, including a brief nurse home visiting program. The proposed study will be conducted in partnership with the brief nurse home visiting program and Sinai Hospital, both located in Baltimore, MD. For the purposes of this study, Sinai Hospital will serve as the community/catchment area. Nurse home visitors enroll new mothers into the nurse home visiting program while they are still in the hospital/maternity ward. When the current study officially begins, nurse home visitors will recruit new mothers into the nurse home visiting program every other day only (on odd dates). Research staff will recruit all Baltimore City residents who give birth at Sinai Hospital, regardless of odd/even birth date, while they are still in the hospital/maternity ward.

Interventions

OTHERNurse Home Visiting Program

Brief nurse home visiting program

Sponsors

LifeBridge Health
CollaboratorOTHER
University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

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.

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

Inclusion criteria

* Mother and Infant are Baltimore City Residents * Mother gave birth to infant at Sinai Hospital in Baltimore, MD beginning approximately July 15, 2019 * Mother speaks English

Exclusion criteria

* Mother and Infant are not Baltimore City Residents * Mother did not give birth to infant at Sinai Hospital in Baltimore, MD beginning approximately July 15, 2019 * Mother does not speak English

Design outcomes

Primary

MeasureTime frameDescription
Infant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health Statuscollected 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 minfant 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?
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Statuscollected 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 mmaternal wellbeing as assessed using study-specific structured interview, i.e.: Are you or your partner using any form of contraception or birth control at this time? Since you came home from the hospital after birth, have you had to go to your doctor or a health clinic, to the emergency room or emergency department, or stayed overnight in the hospital for illness/injury/emergency? Did you complete your 6-week post-partum check-up? Do you currently have any kind of chronic health conditions? If yes, are you under the regular care of a doctor to help manage this condition? What type of health care provider do you regularly see? In general, how do you pay for your health care? If you were sick and you wanted to be seen by a doctor, where would you go for care?
Home Safety as Assessed Using H.O.M.E.Planned collection: at/around the time infant turned 6 months old; As this is an in-home observational measure only and all in-home data collection was halted due to COVID-related precautions, we do not have data for the H.O.M.E.The Home Observation for Measurement of Environment (HOME) Inventory is an observational instrument of 45 items that measures a child's home environment, including the emotional and verbal responsivity of the mother, acceptance of the child, organization of the environment, provision of appropriate play materials, maternal involvement with the child, and variety in daily stimulation.
Parenting Indicators (Discipline)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 m4 items to measure parental use of discipline (yes/no), type of physical punishment used (spank/tap)
Study-specific Structured Maternal Report Interview on Quality Rating of Child's Care Center of Child Care, According to the EXCELS Rating Systemcollected 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 mmaternal report of quality of child care during study-specific structured interview, according to the EXCELS rating system. EXCELS is the state's child care quality rating system for all licensed family and center-based child care providers in Maryland. Programs are rated on a 1 to 5 scale according to multiple quality indicators, including developmentally appropriate learning and practice, accreditation and rating scales, licensing and compliance, staff qualifications and professional development, administrative policies, etc. Higher numbers reflect higher overall quality of the child care program.
Study-specific Structured Maternal Report Interview on Infant Immunizationscollected 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 mmaternal report of infant being up to date on immunizations during study-specific structured interview, i.e. Is the baby up to date on his/her immunizations? (yes/no)
Study-specific Structured Maternal Report Interview on Infant Well-baby Visitscollected 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 mmaternal report of infant having their well-baby visit during study-specific structured interview, i.e. When was the last time you took the baby to see the doctor for a general examination (also known as a well-baby visit')? They were asked to select from the following options: within the last month, within the last three months, more than three months ago, I don't remember, I don't take my baby to the doctor for general examinations
Study-specific Structured Maternal Report Interview on the Number of Community Resources Family Usescollected 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 mmaternal report of number of resources used during study-specific structured interview, i.e. a sum of all of the resources named in the interview
Home Quality as Assessed Using H.O.M.E.Planned collection: at/around the time infant turned 6 months old; As this is an in-home measure only and all in-home data collection was halted due to COVID-related precautions, we do not have data for the H.O.M.E.home quality as assessed using H.O.M.E. during study-specific structured interview
Study-specific Structured Maternal Report Interview on Infant Emergency Room Usecollected 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 mmaternal report of infant emergency room use during study-specific structured interview, i.e.: Since you came home from the hospital after birth, has the baby had to go to the emergency room or emergency department for an illness, injury, or emergency?
Data Collection From Records on Infant Emergency Room UseIntended collection time: five and a half years post-psychosocial interview; Unable to collect due to study terminationrecords from Sinai Hospital and/or the Maryland Department of Health indicating number of emergency room visits
Study-specific Structured Maternal Report Interview on Number of Infant Overnight Hospital Stayscollected 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 mmaternal report of number of infant overnight hospital stays during study-specific structured interview, i.e.: Since you came home from the hospital after birth, has the baby stayed overnight in the hospital for an illness, injury, or emergency? If yes, how many times?
Data Collection From Records on Infant Overnight Hospital Stayscollected 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 mrecords from Sinai Hospital and/or the Maryland Department of Health indicating number of overnight hospital stays
Study-specific Structured Maternal Report Interview on Father's Supportive Parentingcollected 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 mmaternal 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?
Study-specific Structured Maternal Report Interview on Family Use of Community Resourcescollected 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 mMothers were asked if they use the following services (yes/no): Food Stamps, Special Supplemental Nutrition Program for Women, Infants and Children (WIC), Supplemental Security Income (SSI), Work First- Family Cash Assistance, Medicaid (for the mother) or State Children's Health Insurance Program (S-CHIP) for child, Private health insurance, Job seeking assistance, Transportation assistance, Shelter/housing assistance, Food assistance, Clothing assistance, Furniture assistance, Heating/cooling assistance, Family planning clinic, Breastfeeding support, Mental health counseling, Substance use support, Couples counseling or domestic violence help, Veterans Affairs, Child Protective Services (CPS), Faith-based services, Maryland Family Network, The ARC of Maryland (for disabilities), B'more for Healthy Babies (services to prevent infant mortality), child care subsidy service, child care center or home based child care with other children or individual child care provider, Other
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)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 mMothers were asked if they use the following services (yes/no): Food Stamps, Special Supplemental Nutrition Program for Women, Infants and Children (WIC), Supplemental Security Income (SSI), Work First- Family Cash Assistance, Medicaid (for the mother) or State Children's Health Insurance Program (S-CHIP) for child, Private health insurance, Job seeking assistance, Transportation assistance, Shelter/housing assistance, Food assistance, Clothing assistance, Furniture assistance, Heating/cooling assistance, Family planning clinic, Breastfeeding support, Mental health counseling, Substance use support, Couples counseling or domestic violence help, Veterans Affairs, Child Protective Services (CPS), Faith-based services, Maryland Family Network, The ARC of Maryland (for disabilities), B'more for Healthy Babies (services to prevent infant mortality), child care subsidy service, child care center or home based child care with other children or individual child care provider, Other
Maternal Wellbeing as Assessed Using the Parenting Stress Indexcollected 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 mDuring the study-specific structured interview, maternal stress was measured using the Parenting Stress Index-Short Form (PSI-SF), which includes three subscales-Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child, each containing 12 items. Mothers rated each of the 36 items on a 5-point scale ranging from strongly disagree (1) to strongly agree (5). Subscales are summed to compute a total score. The possible range is 36-180. Higher raw scores generally indicate higher levels of stress.
Maternal Social Support as Assessed Using The Social Provisions Scalecollected 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 mMaternal social support was assessed using The Social Provisions Scale during study-specific structured interview. Mothers were asked to think about their current relationships and rate 24 statements on a scale of 1 (strongly disagree) to 4 (strongly agree). The possible total range is 12-48, with higher scores indicating higher levels of social support.
Maternal Wellbeing as Assessed Using the Edinburgh Postpartum Depression Scalecollected 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 mmaternal wellbeing as assessed using Edinburgh Postpartum Depression Scale (EPDS) during study-specific structured interview The possible range for the EPDS is 0-30, with higher scores indicating more depressive symptoms. Scores greater than or equal to 13 indicate possible clinical depression.
Maternal Wellbeing as Assessed Using the Generalized Anxiety Disorder (GAD-7)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 mDuring 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.

Secondary

MeasureTime frameDescription
Maternal Wellbeing as Assessed Using the Adverse Childhood Experiences (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 mmaternal wellbeing as assessed using the Adverse Childhood Experiences (ACEs) during study-specific structured interview. The range is 0-10 ACEs total.
Data Collection From Records of Rates of Official Investigations for Child MaltreatmentIntended collection time: five and a half years post-psychosocial interview; Unable to collect due to study terminationrecords from the Maryland Department of Human Services
Maternal Wellbeing as Assessed Using the Adult Attachment Style (AAS)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 mIn 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)....
Neighborhood Quality as Assessed Using The Neighborhood Collective Efficacycollected 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 mneighborhood quality as assessed using The Neighborhood Collective Efficacy during study-specific structured interview
Study-specific Structured Maternal Report Interview on Transportationcollected 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 mstudy-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?

Other

MeasureTime frameDescription
Data Collection From Records of Early Educational Achievement: Rates of Kindergarten Attendance, ExploratoryIntended collection time: five and a half years post-psychosocial interview; Unable to collect due to study terminationrecords from the Maryland State Department of Education, exploratory
Data Collection From Records of Early Educational Achievement: Kindergarten Readiness Scores, ExploratoryIntended collection time: five and a half years post-psychosocial interview; Unable to collect due to study terminationrecords from the Maryland State Department of Education, exploratory

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
Completed Interview
The mothers enrolled in the study and completed the interview.
152
Total152

Baseline characteristics

CharacteristicCompleted Interview
Age, Continuous29.87 years
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
146 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
4 Participants
Race (NIH/OMB)
Black or African American
71 Participants
Race (NIH/OMB)
More than one race
6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
71 Participants
Sex: Female, Male
Female
152 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

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

Time frame: Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination

Population: Due to COVID-19, this study ended prematurely, in March 2020. No follow-up interview was conducted.

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

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

ArmMeasureValue (MEAN)Dispersion
Infant ER VisitData Collection From Records on Infant Overnight Hospital Stays0.05 number of overnight hospital staysStandard Deviation 0.21
Primary

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.

Population: Due to COVID-19 precautions, we did not collect these data.

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.

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.

Population: Due to COVID-19 precautions, we did not collect these data.

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?

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

Population: Multiple outcomes are measured for infant wellbeing. Therefore, not all outcomes add up to N = 152

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Infant ER VisitInfant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health StatusInfant has a regular bedtimeyes124 Participants
Infant ER VisitInfant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health StatusCurrently breastfeedingyes138 Participants
Infant ER VisitInfant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health StatusCurrently breastfeedingno14 Participants
Infant ER VisitInfant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health StatusInfant has a regular bedtimeno27 Participants
Infant ER VisitInfant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health StatusInfant has regular bedtime routineyes138 Participants
Infant ER VisitInfant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health StatusInfant has regular bedtime routineno13 Participants
Infant ER VisitInfant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health StatusSmoking in householdyes2 Participants
Infant ER VisitInfant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health StatusSmoking in householdno150 Participants
Infant ER VisitInfant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health StatusDoes the baby have a healthcare provideryes148 Participants
Infant ER VisitInfant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health StatusDoes the baby have a healthcare providerno2 Participants
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.

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

ArmMeasureValue (MEAN)Dispersion
Infant ER VisitMaternal Social Support as Assessed Using The Social Provisions Scale44.26 total score on a scaleStandard Deviation 5.07
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?

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

Population: Participants did not respond to all questions and each row represents another outcome related to the main outcome.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusChronic health conditions such as high blood pressure or diabetesNo130 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusDr. or clinic visit(s) for mother illness, injury, or emergencyYes51 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusDr. or clinic visit(s) for mother illness, injury, or emergencyNo101 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusDr. or clinic visit(s) for mother illness, injury, or emergencyRefused or N/A0 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusCompleted maternal 6-week post-partum check-upYes142 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusCompleted maternal 6-week post-partum check-upNo10 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusCompleted maternal 6-week post-partum check-upRefused or N/A0 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusChronic health conditions such as high blood pressure or diabetesYes21 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusChronic health conditions such as high blood pressure or diabetesRefused or N/A0 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusSees a health care provider regularlyYes125 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusSees a health care provider regularlyNo27 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusSees a health care provider regularlyRefused or N/A0 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusUse of contraception or birth control at this timeYes100 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusUse of contraception or birth control at this timeNo44 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusUse of contraception or birth control at this timeRefused or N/A6 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusMother ER visitsYes24 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusMother ER visitsNo128 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusMother ER visitsRefused or N/A0 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusHospital overnight for mother illness, injury, or emergencyYes8 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusHospital overnight for mother illness, injury, or emergencyNo144 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusHospital overnight for mother illness, injury, or emergencyRefused or N/A0 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusIf sick and wanted to be seen by a doctor, mother would go to...PCPYes109 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusIf sick and wanted to be seen by a doctor, mother would go to...PCPNo43 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusIf sick and wanted to be seen by a doctor, mother would go to...PCPRefused or N/A0 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusIf sick and wanted to be seen by a doctor, mother would go to...health care clinic/urgent careYes27 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusIf sick and wanted to be seen by a doctor, mother would go to...health care clinic/urgent careNo125 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusIf sick and wanted to be seen by a doctor, mother would go to...health care clinic/urgent careRefused or N/A0 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusIf sick and wanted to be seen by a doctor, mother would go to...emergency roomYes10 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusIf sick and wanted to be seen by a doctor, mother would go to...emergency roomNo142 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusIf sick and wanted to be seen by a doctor, mother would go to...emergency roomRefused or N/A0 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusIf sick and wanted to be seen by a doctor, mother would go to...(Other)Yes6 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusIf sick and wanted to be seen by a doctor, mother would go to...(Other)No146 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusIf sick and wanted to be seen by a doctor, mother would go to...(Other)Refused or N/A0 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusPayment for health care: out of pocketYes2 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusPayment for health care: out of pocketNo150 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusPayment for health care: out of pocketRefused or N/A0 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusPayment for health care: health insuranceYes78 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusPayment for health care: health insuranceNo74 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusPayment for health care: health insuranceRefused or N/A0 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusPayment for health care: MedicaidYes68 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusPayment for health care: MedicaidNo84 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusPayment for health care: MedicaidRefused or N/A0 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusPayment for health care: OtherYes4 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusPayment for health care: OtherNo148 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using Study-specific Structured Interview on Health StatusPayment for health care: OtherRefused or N/A0 Participants
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.

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

Population: N does not equal 152 due to missing data.

ArmMeasureValue (MEAN)Dispersion
Infant ER VisitMaternal Wellbeing as Assessed Using the Edinburgh Postpartum Depression Scale4.72 units on a scaleStandard Deviation 3.93
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.

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

ArmMeasureValue (MEAN)Dispersion
Infant ER VisitMaternal Wellbeing as Assessed Using the Generalized Anxiety Disorder (GAD-7)4.01 total score on a scaleStandard Deviation 3.53
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.

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

Population: 3 participants did not respond to this question

ArmMeasureValue (MEAN)Dispersion
Infant ER VisitMaternal Wellbeing as Assessed Using the Parenting Stress Index53.56 total score on a scaleStandard Deviation 19.59
Primary

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

Population: N's may not add up to 152 due to missing data

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Infant ER VisitParenting Indicators (Discipline)Use of physical disciplineYes2 Participants
Infant ER VisitParenting Indicators (Discipline)Use of physical disciplineNo148 Participants
Infant ER VisitParenting Indicators (Discipline)If yes, type of physical punishment used: spank/pop or slapYes1 Participants
Infant ER VisitParenting Indicators (Discipline)If yes, type of physical punishment used: spank/pop or slapNo1 Participants
Infant ER VisitParenting Indicators (Discipline)If yes, type of physical punishment used: TapYes1 Participants
Infant ER VisitParenting Indicators (Discipline)If yes, type of physical punishment used: TapNo1 Participants
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

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

ArmMeasureValue (MEAN)Dispersion
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources3.99 Number of resources usedStandard Deviation 2.24
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

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

Population: Total n's may be less than 152 due to missing data.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)SNAPyes61 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)SNAPno91 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)WICyes89 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)WICno63 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)SSIyes2 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)SSIno150 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)TCAyes17 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)TCAno135 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Medicaidyes75 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Medicaidno77 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)SCHIPyes96 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)SCHIPno56 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Private health insuranceyes74 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Private health insuranceno78 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Job servicesyes7 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Job servicesno145 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Transportation assistanceyes4 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Transportation assistanceno148 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Shelter assistanceyes0 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Shelter assistanceno152 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Housing assistanceyes3 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Housing assistanceno149 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Food bankyes9 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Food bankno142 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Clothing assistanceyes3 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Clothing assistanceno149 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Furniture assistanceyes0 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Furniture assistanceno152 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Heating/cooling assistanceyes2 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Heating/cooling assistanceno150 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Family planning clinicyes3 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)Family planning clinicno147 Participants
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?

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

Population: 42 mothers did not respond

ArmMeasureValue (MEAN)Dispersion
Infant ER VisitStudy-specific Structured Maternal Report Interview on Father's Supportive Parenting20.94 units on a scaleStandard Deviation 9.21
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?

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

Population: Those who completed the interview

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Infant ER VisitStudy-specific Structured Maternal Report Interview on Infant Emergency Room UseYes20 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Infant Emergency Room UseNo132 Participants
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)

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Infant ER VisitStudy-specific Structured Maternal Report Interview on Infant ImmunizationsYes138 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Infant ImmunizationsNo14 Participants
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

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

Population: N's may not add to 152 due to missing data.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Infant ER VisitStudy-specific Structured Maternal Report Interview on Infant Well-baby VisitsWithin the last month72 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Infant Well-baby VisitsWithin the last 3 months75 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Infant Well-baby VisitsMore than 3 months ago5 Participants
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?

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Infant ER VisitStudy-specific Structured Maternal Report Interview on Number of Infant Overnight Hospital StaysYes7 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Number of Infant Overnight Hospital StaysNo145 Participants
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.

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

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Infant ER VisitStudy-specific Structured Maternal Report Interview on Quality Rating of Child's Care Center of Child Care, According to the EXCELS Rating SystemEXCELS Level 10 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Quality Rating of Child's Care Center of Child Care, According to the EXCELS Rating SystemEXCELS Level 20 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Quality Rating of Child's Care Center of Child Care, According to the EXCELS Rating SystemEXCELS Level 30 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Quality Rating of Child's Care Center of Child Care, According to the EXCELS Rating SystemEXCELS Level 42 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Quality Rating of Child's Care Center of Child Care, According to the EXCELS Rating SystemEXCELS Level 51 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on Quality Rating of Child's Care Center of Child Care, According to the EXCELS Rating SystemLevel unknown12 Participants
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

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

ArmMeasureValue (MEAN)Dispersion
Infant ER VisitStudy-specific Structured Maternal Report Interview on the Number of Community Resources Family Uses3.99 total number of resources usedStandard Deviation 2.24
Secondary

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

Population: Due to COVID-19, this study ended prematurely, in March 2020. No follow-up interview nor record scanning was conducted.

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)....

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

Population: 151 participants responded to this scale

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Infant ER VisitMaternal Wellbeing as Assessed Using the Adult Attachment Style (AAS)Avoidant26 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using the Adult Attachment Style (AAS)Secure118 Participants
Infant ER VisitMaternal Wellbeing as Assessed Using the Adult Attachment Style (AAS)Anxious7 Participants
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.

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

Population: Total number of ACE's (0 - 10)

ArmMeasureValue (MEAN)Dispersion
Infant ER VisitMaternal Wellbeing as Assessed Using the Adverse Childhood Experiences (ACEs)1.5 Total ACEsStandard Deviation 2.12
Secondary

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

Population: (possible range 4-16)

ArmMeasureValue (MEAN)Dispersion
Infant ER VisitNeighborhood Quality as Assessed Using The Neighborhood Collective Efficacy6.85 units on a scaleStandard Deviation 2.96
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?

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

Population: N's may not add to 152 due to missing data.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: own (family) car/taxi or rideshareYes4 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: own (family) car/taxi or rideshareNo148 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationDoes anyone in the household own a working car, van, truck?Yes138 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationDoes anyone in the household own a working car, van, truck?No12 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: own (family) carYes122 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: own (family) carNo30 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: other (family) person's carYes2 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: other (family) person's carNo150 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: own (family) car/public transportationYes2 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: own (family) car/public transportationNo150 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: own (family) car/walkYes2 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: own (family) car/walkNo150 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: Other person's carYes7 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: Other person's carNo145 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: walk/taxi or rideshareYes5 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: walk/taxi or rideshareNo147 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: other person's car/public transportationYes1 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: other person's car/public transportationNo151 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: other person's car/public transit/CASA workerYes1 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: other person's car/public transit/CASA workerNo151 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: taxi/rideshareYes3 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: taxi/rideshareNo149 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: Public transportationYes3 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationForms of transportation used: Public transportationNo149 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationHow easy is it to get where you need to go? -- Very easyYes125 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationHow easy is it to get where you need to go? -- Very easyNo27 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationHow easy is it to get where you need to go?- Somewhat easyYes20 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationHow easy is it to get where you need to go?- Somewhat easyNo132 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationHow easy is it to get where you need to go?-- Moderately easy/difficultYes5 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationHow easy is it to get where you need to go?-- Moderately easy/difficultNo147 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationHow easy is it to get where you need to go?-- extremely difficultYes2 Participants
Infant ER VisitStudy-specific Structured Maternal Report Interview on TransportationHow easy is it to get where you need to go?-- extremely difficultNo150 Participants
Other Pre-specified

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

Population: We did not collect these data.

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

Time frame: Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination

Population: We did not collect these data.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026