Effects of Early Community Services on Child and Family Development

Study Overview
=================
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.

Official Title
-----------------
Effects of Early Community Services on Child and Family Development

Conditions
-----------------
Child Development

Intervention / Treatment
-----------------
* Other: Nurse Home Visiting Program


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse Home Visiting Group<br>This group will be offered services from the nurse home visiting program. | Other: Nurse Home Visiting Program<br>* Brief nurse home visiting program<br>|
| No Intervention: Non-intervention Group<br>This group will not be offered services from the nurse home visiting program. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| study-specific structured maternal report interview on infant emergency room use | maternal report of infant emergency room use during study-specific structured interview, i.e.: Since you came home from the hospital after birth, has the baby had to go to the emergency room or emergency department for an illness, injury, or emergency? | collected at infant's age 6 months | 
| 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 | up to five and a half years post-psychosocial interview (which occurs at infant age 6 months) | 
| study-specific structured maternal report interview on number of infant overnight hospital stays | maternal report of number of infant overnight hospital stays during study-specific structured interview, i.e.: Since you came home from the hospital after birth, has the baby stayed overnight in the hospital for an illness, injury, or emergency? If yes, how many times? | collected at infant's age 6 months | 
| 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 | up to five and a half years post-psychosocial interview (which occurs at infant age 6 months0 | 
| study-specific structured maternal report interview on family use of community resources | maternal report of resources used during study-specific structured interview, i.e.: Did you use this service (Food Stamps, WIC, SSI, Work First- Family Cash Assistance, Medicaid (for the mother) Medicaid or 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 services, Mental health counseling, Substance use services, Couples counseling or domestic violence help, Veterans Services, CPS, the nurse home visiting program nurse home visit, Faith-based services, Child care consultants/Maryland Family Network, The Arc, B'more for Healthy Babies, child care subsidy service, A child care center or home based child care with other children or individual child care provider, Other) | collected at infant's age 6 months | 
| data collection from records on family use of community resources | records from the nurse home visiting program indicating number of community resources used | up to five and a half years post-psychosocial interview (which occurs at infant age 6 months) | 
| maternal wellbeing as assessed using the Parenting Stress Index | maternal wellbeing as assessed using the Parenting Stress Index during study-specific structured interview | collected at infant's age 6 months | 
| maternal wellbeing as assessed using The Social Provisions Scale | maternal wellbeing as assessed using The Social Provisions during study-specific structured interview | collected at infant's age 6 months | 
| maternal wellbeing as assessed using the Edinburgh Postpartum Depression Scale | maternal wellbeing as assessed using Edinburgh Postpartum Depression Scale during study-specific structured interview | collected at infant's age 6 months | 
| maternal wellbeing as assessed using the Generalized Anxiety Disorder (GAD-7) | maternal wellbeing as assessed using the Generalized Anxiety Disorder (GAD-7) during study-specific structured interview | collected at infant's age 6 months | 
| maternal wellbeing as assessed using study-specific structured interview on health status | maternal wellbeing as assessed using study-specific structured interview, i.e.: Are you or your partner using any form of contraception or birth control at this time? Since you came home from the hospital after birth, have you had to go to your doctor or a health clinic, to the emergency room or emergency department, or stayed overnight in the hospital for illness/injury/emergency? Did you complete your 6-week post-partum check-up? Do you currently have any kind of chronic health conditions? If yes, are you under the regular care of a doctor to help manage this condition? What type of health care provider do you regularly see? In general, how do you pay for your health care? If you were sick and you wanted to be seen by a doctor, where would you go for care? | collected at infant's age 6 months | 
| home safety as assessed using H.O.M.E. | home safety as assessed using H.O.M.E. during study-specific structured interview | collected at infant's age 6 months | 
| home quality as assessed using H.O.M.E. | home quality as assessed using H.O.M.E. during study-specific structured interview | collected at infant's age 6 months | 
| study-specific structured maternal report interview on father's supportive parenting | maternal report of father's supportive parenting during study-specific structured interview, i.e.: How frequently does the father/partner (with/to the baby): Play games? Sing songs or nursery rhymes? Read stories? Tell stories? Play inside with toys? Take the baby to visit relatives? Helps the baby get dressed? Feeds the baby? Hug or show physical affection to the baby? Put the baby to bed? How often does he look after the baby? How often does he run errands for you? How often does he fix things around your home, paint, or help make it look nicer in other ways? How often does he take the baby places the baby needs to go? How often does your child's father buy the following items: clothes, toys, medicine, child care items, food or formula, anything else? | collected at infant's age 6 months | 
| mother's supportive parenting as assessed using H.O.M.E. | mother's supportive parenting as assessed using H.O.M.E during study-specific structured interview | collected at infant's age 6 months | 
| study-specific structured maternal report interview on quality of child care using the EXCELS measure | maternal report of quality of child care during study-specific structured interview using the EXCELS measure, which is a rating given to all licensed family and center-based child care providers in Maryland | collected at infant's age 6 months | 
| study-specific structured maternal report interview on infant immunizations | maternal report of infant being up to date on immunizations during study-specific structured interview, i.e. Is the baby up to date on his/her immunizations? (yes/no) | collected at infant's age 6 months | 
| 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')? | collected at infant's age 6 months | 
| study-specific structured maternal report interview on the number of community resources family uses | maternal report of number of resources used during study-specific structured interview, i.e. a sum of all of the resources named in the interview | collected at infant's age 6 months | 
| infant wellbeing assessed using study-specific structured interview on infant health status | infant wellbeing as assessed using study-specific structured interview, i.e.: Are you currently breastfeeding? In no about how old was baby when you stopped breastfeeding? Does baby have a regular bedtime? Does baby have a regular bedtime routine? In which one position do you most often lay your baby down to sleep now? How often does baby sleep in the same bed with you or anyone else? Does anyone who lives in your home smoke cigarettes, cigars, pipes, or e-cigarettes anywhere in inside your home? Does your baby have a healthcare provider whom s/he sees regularly? If baby was sick and you wanted him/her to be seen by a doctor, where would you take baby for care? In general, how do you pay for your baby's health care? | collected at infant's age 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| data collection from records of rates of official investigations for child maltreatment | records from the Maryland Department of Human Services | up to five and a half years post-psychosocial interview | 
| maternal wellbeing as assessed using the Adult Attachment (AAS) | maternal wellbeing as assessed using the Adult Attachment (AAS) during study-specific structured interview | collected at infant's age 6 months | 
| 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 | collected at infant's age 6 months | 
| neighborhood quality as assessed using The Neighborhood Collective Efficacy | neighborhood quality as assessed using The Neighborhood Collective Efficacy during study-specific structured interview | collected at infant's age 6 months | 
| study-specific structured maternal report interview on transportation | study-specific structured maternal report interview on transportation, i.e. Does anyone in your household own a working car, van, or truck? How do you usually get around, for example if you need to go somewhere like to work, the store or the doctor's office? How easy is it for you to get where you need to go (work, store, doctor's office, etc.) by personal car? | collected at infant's age 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nurse Home Visiting