Effects of Early Community Services on Child and Family Development

Effects of Early Community Services on Child and Family Development

Sponsors

Lead Sponsor: University of Maryland, Baltimore

Collaborator: LifeBridge Health

Source University of Maryland, Baltimore
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.

Overall Status Recruiting
Start Date July 18, 2019
Completion Date January 2026
Primary Completion Date January 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
study-specific structured maternal report interview on infant emergency room use collected at infant's age 6 months
data collection from records on infant emergency room use 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 collected at infant's age 6 months
study-specific structured maternal report interview on family use of community resources collected at infant's age 6 months
data collection from records on family use of community resources 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 collected at infant's age 6 months
maternal wellbeing as assessed using The Social Provisions Scale collected at infant's age 6 months
maternal wellbeing as assessed using the Edinburgh Postpartum Depression Scale collected at infant's age 6 months
maternal wellbeing as assessed using the Generalized Anxiety Disorder (GAD-7) collected at infant's age 6 months
maternal wellbeing as assessed using study-specific structured interview on health status collected at infant's age 6 months
home safety as assessed using H.O.M.E. collected at infant's age 6 months
home quality as assessed using H.O.M.E. collected at infant's age 6 months
study-specific structured maternal report interview on father's supportive parenting collected at infant's age 6 months
mother's supportive parenting as assessed using H.O.M.E. collected at infant's age 6 months
study-specific structured maternal report interview on quality of child care using the EXCELS measure collected at infant's age 6 months
study-specific structured maternal report interview on infant immunizations collected at infant's age 6 months
study-specific structured maternal report interview on infant well-baby visits collected at infant's age 6 months
study-specific structured maternal report interview on the number of community resources family uses collected at infant's age 6 months
Secondary Outcome
Measure Time Frame
data collection from records of rates of official investigations for child maltreatment up to five and a half years post-psychosocial interview
maternal wellbeing as assessed using the Adult Attachment (AAS) collected at infant's age 6 months
maternal wellbeing as assessed using the Adverse Childhood Experiences (ACEs) collected at infant's age 6 months
neighborhood quality as assessed using The Neighborhood Collective Efficacy collected at infant's age 6 months
study-specific structured maternal report interview on transportation collected at infant's age 6 months
Enrollment 400
Condition
Intervention

Intervention Type: Other

Intervention Name: Nurse Home Visiting Program

Description: Brief nurse home visiting program

Arm Group Label: Nurse Home Visiting Group

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

Gender: Female

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Lisa J Berlin, PhD Principal Investigator University of Maryland, College Park
Overall Contact

Last Name: Lisa J Berlin, PhD

Phone: 410.706.6392

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
UMaryland | Baltimore, Maryland, 21201, United States Not yet recruiting Lisa Berlin, PhD 410-706-6392 [email protected] Lisa Berlin, PhD Principal Investigator
Sinai Hospital | Baltimore, Maryland, 21215, United States Recruiting Jennifer Berkeley 410-601-9515
Location Countries

United States

Verification Date

August 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Maryland, College Park

Investigator Full Name: Lisa Berlin

Investigator Title: Associate Professor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Nurse Home Visiting Group

Type: Experimental

Description: This group will be offered services from the nurse home visiting program.

Label: Non-intervention Group

Type: No Intervention

Description: This group will not be offered services from the nurse home visiting program.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Participant)

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.

Source: ClinicalTrials.gov