临床试验/NCT04019977

NCT04019977终止不适用

Effects of Early Community Services on Child and Family Development

University of Maryland, Baltimore4 个研究点分布在 1 个国家目标入组 277 人开始时间: 2019年7月18日最近更新: 2025年2月21日

适应症

试验速览

阶段: 不适用
状态: 终止
发起方: University of Maryland, Baltimore
入组人数: 277
试验地点: 4
主要终点: Study-specific Structured Maternal Report Interview on Infant Emergency Room Use

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Single (Participant)

盲法说明

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.

入排标准

性别: Female
接受健康志愿者: 是

入选标准

•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

排除标准

•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

结局指标

主要结局

Study-specific Structured Maternal Report Interview on Infant Emergency Room Use

时间窗: collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m

maternal 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 Use

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

records 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 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?

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

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

Study-specific Structured Maternal Report Interview on Family Use of Community Resources (Cont.)

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.

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.

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.

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.

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?

Home Safety as Assessed Using H.O.M.E.

时间窗: 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.

Home Quality as Assessed Using H.O.M.E.

时间窗: 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 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?

Parenting Indicators (Discipline)

4 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 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.

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)

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

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

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?

次要结局

Data Collection From Records of Rates of Official Investigations for Child Maltreatment(Intended collection time: five and a half years post-psychosocial interview; Unable to collect due to study termination)
Maternal Wellbeing as Assessed Using the Adult Attachment Style (AAS)(collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m)
Study-specific Structured Maternal Report Interview on Transportation(collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m)
Maternal Wellbeing as Assessed Using the Adverse Childhood Experiences (ACEs)(collected at/around the time infant turned 6 months old (approximately 6 months from baseline); Due to COVID-related disruptions, we loosened time parameters to anytime we could reach the family; Mean age = 6.78 m; Acceptable/actual range= 5.8-14 m)
Neighborhood Quality as Assessed Using The Neighborhood Collective Efficacy(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)

研究者

发起方

University of Maryland, Baltimore

申办方类型

Other

责任方

Principal Investigator

主要研究者

Lisa Berlin

Associate Professor

University of Maryland, Baltimore

研究点 (4)

Loading locations...

相似试验

招募中

不适用

Early Institutionalization Intervention Impact ProjectSocioemotional DevelopmentCognitive AbilityBehavioral and Neural Patterns of AttentionBrain FunctionPsychopathology

NCT04165746Boston Children's Hospital220

已完成

2 期

The Pakistan Early Childhood Development Scale Up TrialEarly Child Development and Growth

NCT00715936Aga Khan University1,489

已完成

不适用

Family orientated early intervention enhances social-interactive behaviour of premature infants and mother-infant-interactio

ISRCTN41063599Beta Institute for Research and Development in Social Medicine (Germany)108

尚未招募

Unknown

Community-Based oral health promotio

CTRI/2023/05/052225Dr Lydia Thenmozhi

已完成

不适用

Explorer Babies Early Intervention ProgramPrematureDevelopmental DisabilityMotor DisordersDevelopment, InfantCerebral Palsy

NCT04203589Marmara University60