Effects of Early Community Services on Child and Family Development

NCT ID: NCT04019977

Last Updated: 2025-02-21

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

277 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-18

Study Completion Date

2021-07-19

Brief Summary

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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

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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.

Conditions

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Child Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Nurse Home Visiting Group

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

Group Type EXPERIMENTAL

Nurse Home Visiting Program

Intervention Type OTHER

Brief nurse home visiting program

Non-intervention Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nurse Home Visiting Program

Brief nurse home visiting program

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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LifeBridge Health

OTHER

Sponsor Role collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Lisa Berlin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisa J Berlin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Locations

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UMaryland

Baltimore, Maryland, United States

Site Status

Sinai Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Dodge KA, Goodman WB, Murphy RA, O'Donnell K, Sato J. Randomized controlled trial of universal postnatal nurse home visiting: impact on emergency care. Pediatrics. 2013 Nov;132 Suppl 2(Suppl 2):S140-6. doi: 10.1542/peds.2013-1021M.

Reference Type BACKGROUND
PMID: 24187116 (View on PubMed)

Dodge KA, Goodman WB, Murphy RA, O'Donnell K, Sato J, Guptill S. Implementation and randomized controlled trial evaluation of universal postnatal nurse home visiting. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):S136-43. doi: 10.2105/AJPH.2013.301361. Epub 2013 Dec 19.

Reference Type BACKGROUND
PMID: 24354833 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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HP-00076256

Identifier Type: -

Identifier Source: org_study_id

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