NCT02069782

Brief Summary

MIHOPE is a multi-state study of home visiting programs authorized under the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program. The study is required by the federal Patient Protection and Affordable Care Act of 2010 (ACA), which created the MIECHV program. It is being conducted by MDRC under contract to the Administration for Children and Families within the US Department of Health and Human Services. In conducting the research, MDRC has subcontracted portions of the research to Mathematica Policy Research, Johns Hopkins University, Columbia University, University of Georgia, and James Bell Associates. MIHOPE is randomly assigned 4,229 families nationally to home visiting services or to a comparison group that will receive referrals to other services in the community. The study is seeking to include 88 local home visiting programs (sites) that are funded through MIECHV in approximately 12 states. Data will be collected from families, local home visiting programs, and state and federal administrative data systems to assess the effects of the programs on family outcomes and to learn more about how the programs are run. Sites included in the evaluation will be using one of four national service models (Nurse Family Partnership, Healthy Families America, Parents as Teachers, and Early Head Start-Home Visiting Option) that states have chosen for most of their MIECHV funding. MIHOPE will inform the federal government about the effectiveness of the MIECHV program in its first few years of operation, and it will provide information to help states develop and strengthen home visiting programs in the future. Research findings will be disseminated through a report to Congress in 2015; reports on program impacts, implementation, and on the relationship between program features and program impacts; journal articles; and practitioner briefs.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,232

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
16mo left

Started Oct 2012

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Oct 2012Sep 2027

Study Start

First participant enrolled

October 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
8.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Expected
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

6.3 years

First QC Date

February 19, 2014

Last Update Submit

May 9, 2025

Conditions

Keywords

Pregnancypostpartum programsinfant health services

Outcome Measures

Primary Outcomes (12)

  • New pregnancy after study entry

    Mother has had one or more pregnancies since study entry

    through child's 15th month

  • Any health encounter for injury or ingestion

    Whether the child has had an injury or ingestion that lead to a health encounter.

    through child's 15th month

  • Number of well-child visits

    Number of well-child visits

    through child's 15th month

  • Parental supportiveness

    Parental supportiveness measured from Three Bags interaction of parent with child

    at child's 15th month

  • Quality of home environment

    Quality of home environment measured using the IT-HOME

    at child's 15th month

  • Child has health insurance coverage

    Whether the child has health insurance coverage

    at child's 15th month

  • Behavior problems

    Behavior problems total score from the BITSEA parent report

    at child's 15th month

  • Frequency of minor physical assault of child

    Whether parent reports indicate child has been victim of minor physical assault

    through child's 15th month

  • Frequency of psychological aggression

    Whether parent reports indicate child has been victim of psychological aggression

    through the child's 15th month

  • Any child ED use

    Whether child has visited the ED

    through child's 15th month

  • Language skills in the normal range

    Whether child has language skills in the normal range, as measured through a direct assessment

    at child's 15th month

  • Parent receiving education or training

    Whether parent is receiving education or training

    at child's 15th month

Other Outcomes (14)

  • New birth after study entry

    When focal child is 2.5 years old and when focal child is 3.5 years old

  • Maternal depressive symptoms

    When focal child is 2.5 years old and when focal child is 3.5 years old

  • Health status of mother is rated "fair" or "poor"

    When focal child is 2.5 years old and when focal child is 3.5 years old

  • +11 more other outcomes

Study Arms (1)

Home visiting

EXPERIMENTAL

Home visiting programs in the United States grew from three major approaches that first became prominent in the 1960s: visits by public health nurses to promote infant and child health in disadvantaged families, Head Start home visiting to promote school readiness in hard-to-reach families, and home-based family support to promote positive parenting and prevent child abuse in high-risk families. All of these approaches sought to foster early childhood health and development by intervening in the home to support and improve socialization, health, and education practices.Today, home visiting is seen as a particularly important strategy for high-risk families who may be difficult to engage in other services.

Other: Home visiting

Interventions

Home visits are used to assess family needs, provide support and education, and make referrals to relevant community services. The goals of the programs are to improve child health and development, promote positive parenting, prevent child maltreatment, improve maternal and child health, and increasing parental self-sufficiency.

Also known as: HFA, PAT, EHS, NFP
Home visiting

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible for home visiting program selected to be in the study
  • At least 15 years old
  • Pregnant or have a child under 28 weeks old

You may not qualify if:

  • women already enrolled in home visiting (for example, with an older child)
  • children in foster care in sites using EHS program model
  • homeless families in sites using EHS program model
  • women who speak neither English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MDRC

New York, New York, 10016, United States

Location

Related Publications (5)

  • Charles Michalopoulos, Anne Duggan, Virginia Knox, Jill H. Filene, Helen Lee, Emily K. Snell, Sarah Crowne, Erika Lundquist, Phaedra S. Corso, Justin B. Ingels (2013). Revised Design for the Mother and Infant Home Visiting Program Evaluation. OPRE Report 2013-18. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.

    BACKGROUND
  • Charles Michalopoulos, Helen Lee, Anne Duggan, Erika Lundquist, Ada Tso, Sarah Crowne, Lori Burrell, Jennifer Somers, Jill H. Filene, and Virginia Knox. (2015). The Mother and Infant Home Visiting Program Evaluation: Early Findings on the Maternal, Infant, and Early Childhood Home Visiting Program. OPRE Report 2015-11. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.

    BACKGROUND
  • Charles Michalopoulos, Kristen Faucetta, Carolyn J. Hill, Ximena A. Portilla, Lori Burrell, Helen Lee, Anne Duggan, and Virginia Knox. (2019). Impacts on Family Outcomes of Evidence-Based Early Childhood Home Visiting: Results from the Mother and Infant Home Visiting Program Evaluation. OPRE Report 2019-07. Washington, DC: Office of Planning, Research, and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.

    BACKGROUND
  • Phaedra S. Corso, Justin B. Ingels, and Rebecca L. Walcott. (2022). Costs of Evidence-Based Early Childhood Home Visiting: Results from the Mother and Infant Home Visiting Evaluation. OPRE Report 2022-01. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.

    RESULT
  • Faucetta, Kristen, Charles Michalopoulos, Ximena A. Portilla, and Kelly Saunders 2023. Checking in with Families in the Mother and Infant Home Visiting Program Evaluation. OPRE Report 2023-140. Washington, DC: Office of Planning, Research, and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.

    RESULT

Related Links

MeSH Terms

Interventions

House Calls

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Charles Michalopoulos, PhD

    MDRC

    PRINCIPAL INVESTIGATOR
  • Virginia Knox, PhD

    MDRC

    PRINCIPAL INVESTIGATOR
  • Anne Duggan, ScD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 24, 2014

Study Start

October 1, 2012

Primary Completion

January 1, 2019

Study Completion (Estimated)

September 1, 2027

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

A restricted access file with data at baseline, 15 months, 2.5 years, and 3.5 years has been made available to researchers through ICPSR. All data were masked so that individuals cannot be identified. All data used in the study analysis were included in the file. Details about the files can be found here: https://www.icpsr.umich.edu/web/about/cms/3727.

Time Frame
Data through the 3.5 year follow-up are now available.
Access Criteria
Individuals must apply for access to the data and cannot have knowledge about any individual study participants.
More information

Locations