Nurse Home Visiting for Child Development

Recruiting at 1 trial location

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Non-Baltimore residents, Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

277 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lisa J Berlin, PhD

Principal Investigator

University of Maryland

Eligibility Criteria

This trial is for mothers and infants living in Baltimore City, where the birth took place at Sinai Hospital starting around July 15, 2019. Participants must speak English. It's not open to those who don't meet these location, hospital birth timing, or language requirements.

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

Exclusion Criteria

Mother did not give birth to infant at Sinai Hospital in Baltimore, MD beginning approximately July 15, 2019

Mother and Infant are not Baltimore City Residents

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Enrollment and Initial Assessment

Nurse home visitors enroll new mothers into the nurse home visiting program while they are still in the hospital/maternity ward.

Immediate post-birth

1 visit (in-person)

Intervention

Participants in the experimental group receive services from the nurse home visiting program.

6 months

Regular home visits

Follow-up

Participants are monitored for outcomes such as infant emergency room use, family use of community resources, and maternal wellbeing.

6 months

Structured interviews and data collection

Long-term Follow-up

Exploration of long-term differences in child maltreatment investigations and early educational achievement.

5.5 years

Treatment Details

Interventions

• Nurse Home Visiting Program

Trial Overview The study tests if a nurse home visiting program can improve child development and family outcomes. This includes reducing infant ER visits/hospital stays, increasing use of community resources/quality childcare, improving maternal wellbeing, and enhancing home safety/supportive parenting.

Participant Groups

Group I: Nurse Home Visiting Group Experimental Treatment 1 Intervention

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

Group II: Non-intervention Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

LifeBridge Health

Collaborator

Trials

32

Recruited

4,500+