Trial Outcomes & Findings for Effects of Early Community Services on Child and Family Development (NCT NCT04019977)
NCT ID: NCT04019977
Last Updated: 2025-02-21
Results Overview
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?
TERMINATED
NA
277 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
2025-02-21
Participant Flow
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.
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.
Participant milestones
| Measure |
Completed Interview
Participants who gave birth at Hospital, were City residents, enrolled in the study and completed the interview.
|
|---|---|
|
Overall Study
STARTED
|
152
|
|
Overall Study
COMPLETED
|
152
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Early Community Services on Child and Family Development
Baseline characteristics by cohort
| Measure |
Completed Interview
n=152 Participants
The mothers enrolled in the study and completed the interview.
|
|---|---|
|
Age, Continuous
|
29.87 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
152 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
146 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 mPopulation: Those who completed the interview
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?
Outcome measures
| Measure |
Infant ER Visit
n=152 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Study-specific Structured Maternal Report Interview on Infant Emergency Room Use
Yes
|
20 Participants
|
|
Study-specific Structured Maternal Report Interview on Infant Emergency Room Use
No
|
132 Participants
|
PRIMARY outcome
Timeframe: Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study terminationPopulation: Due to COVID-19, this study ended prematurely, in March 2020. No follow-up interview was conducted.
records from Sinai Hospital and/or the Maryland Department of Health indicating number of emergency room visits
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 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 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?
Outcome measures
| Measure |
Infant ER Visit
n=152 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Study-specific Structured Maternal Report Interview on Number of Infant Overnight Hospital Stays
Yes
|
7 Participants
|
|
Study-specific Structured Maternal Report Interview on Number of Infant Overnight Hospital Stays
No
|
145 Participants
|
PRIMARY outcome
Timeframe: 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 mrecords from Sinai Hospital and/or the Maryland Department of Health indicating number of overnight hospital stays
Outcome measures
| Measure |
Infant ER Visit
n=152 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Data Collection From Records on Infant Overnight Hospital Stays
|
0.05 number of overnight hospital stays
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Infant ER Visit
n=152 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources
|
3.99 Number of resources used
Standard Deviation 2.24
|
PRIMARY outcome
Timeframe: 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 mPopulation: Total n's may be less than 152 due to missing data.
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
Outcome measures
| Measure |
Infant ER Visit
n=152 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
WIC · yes
|
89 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Medicaid · yes
|
75 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Transportation assistance · no
|
148 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Furniture assistance · no
|
152 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
SNAP · yes
|
61 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
SNAP · no
|
91 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
WIC · no
|
63 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
SSI · yes
|
2 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
SSI · no
|
150 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
TCA · yes
|
17 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
TCA · no
|
135 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Medicaid · no
|
77 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
SCHIP · yes
|
96 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
SCHIP · no
|
56 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Private health insurance · yes
|
74 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Private health insurance · no
|
78 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Job services · yes
|
7 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Job services · no
|
145 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Transportation assistance · yes
|
4 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Shelter assistance · yes
|
0 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Shelter assistance · no
|
152 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Housing assistance · yes
|
3 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Housing assistance · no
|
149 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Food bank · yes
|
9 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Food bank · no
|
142 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Clothing assistance · yes
|
3 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Clothing assistance · no
|
149 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Furniture assistance · yes
|
0 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Heating/cooling assistance · yes
|
2 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Heating/cooling assistance · no
|
150 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Family planning clinic · yes
|
3 Participants
|
|
Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)
Family planning clinic · no
|
147 Participants
|
PRIMARY outcome
Timeframe: 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 mPopulation: 3 participants did not respond to this question
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.
Outcome measures
| Measure |
Infant ER Visit
n=149 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Maternal Wellbeing as Assessed Using the Parenting Stress Index
|
53.56 total score on a scale
Standard Deviation 19.59
|
PRIMARY outcome
Timeframe: 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 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.
Outcome measures
| Measure |
Infant ER Visit
n=152 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Maternal Social Support as Assessed Using The Social Provisions Scale
|
44.26 total score on a scale
Standard Deviation 5.07
|
PRIMARY outcome
Timeframe: 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 mPopulation: N does not equal 152 due to missing data.
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.
Outcome measures
| Measure |
Infant ER Visit
n=151 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Maternal Wellbeing as Assessed Using the Edinburgh Postpartum Depression Scale
|
4.72 units on a scale
Standard Deviation 3.93
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Infant ER Visit
n=152 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Maternal Wellbeing as Assessed Using the Generalized Anxiety Disorder (GAD-7)
|
4.01 total score on a scale
Standard Deviation 3.53
|
PRIMARY outcome
Timeframe: 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 mPopulation: Participants did not respond to all questions and each row represents another outcome related to the main outcome.
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?
Outcome measures
| Measure |
Infant ER Visit
n=152 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Dr. or clinic visit(s) for mother illness, injury, or emergency · Yes
|
51 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Completed maternal 6-week post-partum check-up · No
|
10 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Sees a health care provider regularly · Refused or N/A
|
0 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Use of contraception or birth control at this time · Yes
|
100 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Use of contraception or birth control at this time · No
|
44 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Mother ER visits · Refused or N/A
|
0 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
If sick and wanted to be seen by a doctor, mother would go to...emergency room · Yes
|
10 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Payment for health care: Other · No
|
148 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Payment for health care: health insurance · Yes
|
78 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Dr. or clinic visit(s) for mother illness, injury, or emergency · No
|
101 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Dr. or clinic visit(s) for mother illness, injury, or emergency · Refused or N/A
|
0 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Completed maternal 6-week post-partum check-up · Yes
|
142 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Completed maternal 6-week post-partum check-up · Refused or N/A
|
0 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Chronic health conditions such as high blood pressure or diabetes · Yes
|
21 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Chronic health conditions such as high blood pressure or diabetes · No
|
130 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Payment for health care: health insurance · No
|
74 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Chronic health conditions such as high blood pressure or diabetes · Refused or N/A
|
0 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Sees a health care provider regularly · Yes
|
125 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Sees a health care provider regularly · No
|
27 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Use of contraception or birth control at this time · Refused or N/A
|
6 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Mother ER visits · Yes
|
24 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Mother ER visits · No
|
128 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Hospital overnight for mother illness, injury, or emergency · Yes
|
8 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Hospital overnight for mother illness, injury, or emergency · No
|
144 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Hospital overnight for mother illness, injury, or emergency · Refused or N/A
|
0 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
If sick and wanted to be seen by a doctor, mother would go to...PCP · Yes
|
109 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
If sick and wanted to be seen by a doctor, mother would go to...PCP · No
|
43 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
If sick and wanted to be seen by a doctor, mother would go to...PCP · Refused or N/A
|
0 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
If sick and wanted to be seen by a doctor, mother would go to...health care clinic/urgent care · Yes
|
27 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
If sick and wanted to be seen by a doctor, mother would go to...health care clinic/urgent care · No
|
125 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
If sick and wanted to be seen by a doctor, mother would go to...health care clinic/urgent care · Refused or N/A
|
0 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
If sick and wanted to be seen by a doctor, mother would go to...emergency room · No
|
142 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
If sick and wanted to be seen by a doctor, mother would go to...emergency room · Refused or N/A
|
0 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
If sick and wanted to be seen by a doctor, mother would go to...(Other) · Yes
|
6 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
If sick and wanted to be seen by a doctor, mother would go to...(Other) · No
|
146 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
If sick and wanted to be seen by a doctor, mother would go to...(Other) · Refused or N/A
|
0 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Payment for health care: out of pocket · Yes
|
2 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Payment for health care: out of pocket · No
|
150 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Payment for health care: out of pocket · Refused or N/A
|
0 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Payment for health care: health insurance · Refused or N/A
|
0 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Payment for health care: Medicaid · Yes
|
68 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Payment for health care: Medicaid · No
|
84 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Payment for health care: Medicaid · Refused or N/A
|
0 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Payment for health care: Other · Yes
|
4 Participants
|
|
Maternal Wellbeing as Assessed Using Study-specific Structured Interview on Health Status
Payment for health care: Other · Refused or N/A
|
0 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 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.
home quality as assessed using H.O.M.E. during study-specific structured interview
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 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 mPopulation: 42 mothers did not respond
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?
Outcome measures
| Measure |
Infant ER Visit
n=110 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Study-specific Structured Maternal Report Interview on Father's Supportive Parenting
|
20.94 units on a scale
Standard Deviation 9.21
|
PRIMARY outcome
Timeframe: 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 mPopulation: N's may not add up to 152 due to missing data
4 items to measure parental use of discipline (yes/no), type of physical punishment used (spank/tap)
Outcome measures
| Measure |
Infant ER Visit
n=152 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Parenting Indicators (Discipline)
Use of physical discipline · Yes
|
2 Participants
|
|
Parenting Indicators (Discipline)
Use of physical discipline · No
|
148 Participants
|
|
Parenting Indicators (Discipline)
If yes, type of physical punishment used: spank/pop or slap · Yes
|
1 Participants
|
|
Parenting Indicators (Discipline)
If yes, type of physical punishment used: spank/pop or slap · No
|
1 Participants
|
|
Parenting Indicators (Discipline)
If yes, type of physical punishment used: Tap · Yes
|
1 Participants
|
|
Parenting Indicators (Discipline)
If yes, type of physical punishment used: Tap · No
|
1 Participants
|
PRIMARY outcome
Timeframe: 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 mPopulation: 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.
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.
Outcome measures
| Measure |
Infant ER Visit
n=15 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Study-specific Structured Maternal Report Interview on Quality Rating of Child's Care Center of Child Care, According to the EXCELS Rating System
EXCELS Level 1
|
0 Participants
|
|
Study-specific Structured Maternal Report Interview on Quality Rating of Child's Care Center of Child Care, According to the EXCELS Rating System
EXCELS Level 2
|
0 Participants
|
|
Study-specific Structured Maternal Report Interview on Quality Rating of Child's Care Center of Child Care, According to the EXCELS Rating System
EXCELS Level 3
|
0 Participants
|
|
Study-specific Structured Maternal Report Interview on Quality Rating of Child's Care Center of Child Care, According to the EXCELS Rating System
EXCELS Level 4
|
2 Participants
|
|
Study-specific Structured Maternal Report Interview on Quality Rating of Child's Care Center of Child Care, According to the EXCELS Rating System
EXCELS Level 5
|
1 Participants
|
|
Study-specific Structured Maternal Report Interview on Quality Rating of Child's Care Center of Child Care, According to the EXCELS Rating System
Level unknown
|
12 Participants
|
PRIMARY outcome
Timeframe: 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 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)
Outcome measures
| Measure |
Infant ER Visit
n=152 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Study-specific Structured Maternal Report Interview on Infant Immunizations
Yes
|
138 Participants
|
|
Study-specific Structured Maternal Report Interview on Infant Immunizations
No
|
14 Participants
|
PRIMARY outcome
Timeframe: 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 mPopulation: N's may not add to 152 due to missing data.
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
Outcome measures
| Measure |
Infant ER Visit
n=152 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Study-specific Structured Maternal Report Interview on Infant Well-baby Visits
Within the last month
|
72 Participants
|
|
Study-specific Structured Maternal Report Interview on Infant Well-baby Visits
Within the last 3 months
|
75 Participants
|
|
Study-specific Structured Maternal Report Interview on Infant Well-baby Visits
More than 3 months ago
|
5 Participants
|
PRIMARY outcome
Timeframe: 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 report of number of resources used during study-specific structured interview, i.e. a sum of all of the resources named in the interview
Outcome measures
| Measure |
Infant ER Visit
n=152 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Study-specific Structured Maternal Report Interview on the Number of Community Resources Family Uses
|
3.99 total number of resources used
Standard Deviation 2.24
|
PRIMARY outcome
Timeframe: 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 mPopulation: Multiple outcomes are measured for infant wellbeing. Therefore, not all outcomes add up to N = 152
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?
Outcome measures
| Measure |
Infant ER Visit
n=152 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Infant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health Status
Currently breastfeeding · yes
|
138 Participants
|
|
Infant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health Status
Currently breastfeeding · no
|
14 Participants
|
|
Infant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health Status
Infant has a regular bedtime · yes
|
124 Participants
|
|
Infant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health Status
Infant has a regular bedtime · no
|
27 Participants
|
|
Infant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health Status
Infant has regular bedtime routine · yes
|
138 Participants
|
|
Infant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health Status
Infant has regular bedtime routine · no
|
13 Participants
|
|
Infant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health Status
Smoking in household · yes
|
2 Participants
|
|
Infant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health Status
Smoking in household · no
|
150 Participants
|
|
Infant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health Status
Does the baby have a healthcare provider · yes
|
148 Participants
|
|
Infant Wellbeing Assessed Using Study-specific Structured Interview on Infant Health Status
Does the baby have a healthcare provider · no
|
2 Participants
|
SECONDARY outcome
Timeframe: Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study terminationPopulation: Due to COVID-19, this study ended prematurely, in March 2020. No follow-up interview nor record scanning was conducted.
records from the Maryland Department of Human Services
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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 mPopulation: 151 participants responded to this scale
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)....
Outcome measures
| Measure |
Infant ER Visit
n=151 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Maternal Wellbeing as Assessed Using the Adult Attachment Style (AAS)
Avoidant
|
26 Participants
|
|
Maternal Wellbeing as Assessed Using the Adult Attachment Style (AAS)
Secure
|
118 Participants
|
|
Maternal Wellbeing as Assessed Using the Adult Attachment Style (AAS)
Anxious
|
7 Participants
|
SECONDARY outcome
Timeframe: 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 mPopulation: Total number of ACE's (0 - 10)
maternal wellbeing as assessed using the Adverse Childhood Experiences (ACEs) during study-specific structured interview. The range is 0-10 ACEs total.
Outcome measures
| Measure |
Infant ER Visit
n=144 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Maternal Wellbeing as Assessed Using the Adverse Childhood Experiences (ACEs)
|
1.5 Total ACEs
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: 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 mPopulation: (possible range 4-16)
neighborhood quality as assessed using The Neighborhood Collective Efficacy during study-specific structured interview
Outcome measures
| Measure |
Infant ER Visit
n=141 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Neighborhood Quality as Assessed Using The Neighborhood Collective Efficacy
|
6.85 units on a scale
Standard Deviation 2.96
|
SECONDARY outcome
Timeframe: 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 mPopulation: N's may not add to 152 due to missing data.
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?
Outcome measures
| Measure |
Infant ER Visit
n=152 Participants
If the infant has visited the ER, and if so, how many times.
|
|---|---|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: taxi/rideshare · No
|
149 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Does anyone in the household own a working car, van, truck? · Yes
|
138 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Does anyone in the household own a working car, van, truck? · No
|
12 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: own (family) car · Yes
|
122 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: own (family) car · No
|
30 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: other (family) person's car · Yes
|
2 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: other (family) person's car · No
|
150 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: own (family) car/taxi or rideshare · Yes
|
4 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: own (family) car/taxi or rideshare · No
|
148 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: own (family) car/public transportation · Yes
|
2 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: own (family) car/public transportation · No
|
150 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: own (family) car/walk · Yes
|
2 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: own (family) car/walk · No
|
150 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: Other person's car · Yes
|
7 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: Other person's car · No
|
145 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: walk/taxi or rideshare · Yes
|
5 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: walk/taxi or rideshare · No
|
147 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: other person's car/public transportation · Yes
|
1 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: other person's car/public transportation · No
|
151 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: other person's car/public transit/CASA worker · Yes
|
1 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: other person's car/public transit/CASA worker · No
|
151 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: taxi/rideshare · Yes
|
3 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: Public transportation · Yes
|
3 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
Forms of transportation used: Public transportation · No
|
149 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
How easy is it to get where you need to go? -- Very easy · Yes
|
125 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
How easy is it to get where you need to go? -- Very easy · No
|
27 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
How easy is it to get where you need to go?- Somewhat easy · Yes
|
20 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
How easy is it to get where you need to go?- Somewhat easy · No
|
132 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
How easy is it to get where you need to go?-- Moderately easy/difficult · Yes
|
5 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
How easy is it to get where you need to go?-- Moderately easy/difficult · No
|
147 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
How easy is it to get where you need to go?-- extremely difficult · Yes
|
2 Participants
|
|
Study-specific Structured Maternal Report Interview on Transportation
How easy is it to get where you need to go?-- extremely difficult · No
|
150 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study terminationPopulation: We did not collect these data.
records from the Maryland State Department of Education, exploratory
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study terminationPopulation: We did not collect these data.
records from the Maryland State Department of Education, exploratory
Outcome measures
Outcome data not reported
Adverse Events
No Adverse Events Were Monitored
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lisa Berlin
University of Maryland School of Social Work
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place