Mother and Infant Home Visiting Program Evaluation-Strong Start

NCT02076204 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1059

Last updated 2019-02-06

No results posted yet for this study

Summary

Adverse birth outcomes result in significant emotional and economic costs for families and communities. Research suggests that poor birth outcomes are influenced by a variety of social, psychological, behavioral, environmental, and biological factors. Home visiting programs represent a promising means of impacting each of these areas.

The Mother and Infant Home Visiting Program Evaluation - Strong Start (MIHOPE-Strong Start) will evaluate the effectiveness of two evidence-based home visiting models at improving birth outcomes for women who are enrolled in Medicaid or CHIP. The two models to be studied - Healthy Families America (HFA) and Nurse-Family Partnership (NFP) - have both shown some evidence of improving birth outcomes in prior research.

The overall goals of the study are to determine whether home visiting programs improve birth outcomes and reduce health care costs in the child's first year. In addition, the evaluation is designed to investigate the features of local programs and of home visitation that lead to greater effects on birth outcomes and health care costs. The study includes an impact analysis to measure what difference home visiting programs make on maternal prenatal health and health care use, preterm birth and other birth outcomes, and infant health and health care use. It also includes an implementation analysis that will describe the families who participate and examine how the program models operate in their local and state contexts. The primary data used in the study are expected to be from surveys completed by families and home visiting staff, Medicaid and CHIP data, vital records, and program service records. Among families who are eligible for the study, random assignment will be used to select families for enrollment in home visiting services. Those selected for home visiting services will form the program group, and those not selected will form a comparison group. The research team will monitor both groups over time to see if differences emerge in the outcome areas mentioned above. Although the study will affect which families can enroll in home visiting services, no fewer families will be served as a result of the study.

Conditions

  • Pregnancy
  • Postpartum Care
  • Infant Development

Interventions

BEHAVIORAL

Home visiting

MIHOPE-Strong Start will examine local programs that use either of two home visiting service models that have shown previous evidence of improving birth outcomes: Healthy Families America (HFA) and Nurse-Family Partnership (NFP). HFA and NFP provide disadvantaged expectant mothers with individualized in-home services, including assessment of prenatal and postnatal risks to child well-being; referrals to needed health care or social services; and direct education of parents by home visitors on such topics as healthy prenatal behaviors, parenting, and child development.

Sponsors & Collaborators

Principal Investigators

  • Charles Michalopoulos, Ph.D. · MDRC

  • Virginia Knox, Ph.D. · MDRC

  • Keith Kranker, Ph.D. · Mathematica Policy Research, Inc.

  • Anne Duggan, Ph.D. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2018-09-30
Completion
2019-01-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02076204 on ClinicalTrials.gov