Home Visiting for Mother and Infant Well-being

(MIHOPE Trial)

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: MDRC

Disqualifiers: Already enrolled, Foster care, Homeless, others

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

Compensation: Varies

Number of Visits: 4

4232 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Home Visiting for improving mother and infant well-being?

Research shows that home visiting programs can lead to moderate improvements in mothers' well-being and infant care, especially when mothers feel close to their home visitors and when the visitors are trained professionals. High-risk mothers tend to benefit more, particularly in infant care. ^{1 2 3 4 5}

Is home visiting safe for mothers and infants?

Home visiting programs have been shown to improve health and safety outcomes for mothers and infants, such as safer homes and better health practices. These programs are generally considered safe and beneficial for families, especially those at high risk for negative health outcomes. ^{1 2 6 7 8}

How does the home visiting treatment for mother and infant well-being differ from other treatments?

Home visiting is unique because it involves trained professionals visiting mothers and infants in their homes to provide support and guidance, focusing on improving the mother-infant relationship and overall family well-being. Unlike other treatments that may occur in clinical settings, this approach is personalized and can address specific needs in the family's natural environment, which is particularly beneficial for high-risk or vulnerable populations. ^{1 9 10 11 12}

What is the purpose of this trial?

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.

Research Team

Virginia Knox, PhD

Principal Investigator

MDRC

Charles Michalopoulos, PhD

Principal Investigator

MDRC

Anne Duggan, ScD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for pregnant individuals or those with a child under 28 weeks old, at least 15 years of age, and eligible for the home visiting program. It excludes women already in such programs, children in foster care using EHS model sites, homeless families at EHS sites, and non-English/Spanish speakers.

Inclusion Criteria

I am 15 years old or older.

Eligible for home visiting program selected to be in the study

Pregnant or have a child under 28 weeks old

Exclusion Criteria

homeless families in sites using EHS program model

children in foster care in sites using EHS program model

women already enrolled in home visiting (for example, with an older child)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Initial data collection including a one-hour survey and home environment assessment

1-2 weeks

1 visit (in-person)

Home Visiting Program

Participants receive home visiting services or are referred to other community services

15 months

Regular visits (frequency varies)

Follow-up Data Collection

Follow-up data collection when the child is 15 months old, including surveys and assessments

1-2 weeks

1 visit (in-person)

Extended Follow-up

Additional follow-up surveys conducted when the child is 2.5 and 3.5 years old

2 years

2 visits (in-person)

Treatment Details

Interventions

• Home Visiting

Trial Overview The MIHOPE study tests the effectiveness of home visiting services versus community service referrals on family outcomes. It involves over four thousand families across multiple states and uses data from various sources to evaluate these effects.

Participant Groups

Group I: Home visiting Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

MDRC

Lead Sponsor

Trials

8

Recruited

18,900+

Mathematica Policy Research, Inc.

Collaborator

Trials

68

Recruited

31,130,000+

University of Georgia

Collaborator

Trials

109

Recruited

43,500+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

James Bell Associates

Collaborator

Trials

2

Recruited

5,300+

Findings from Research

In a study of 643 high-risk families, home visiting programs did not show significant differences in short- and long-term outcomes for mothers compared to control groups, indicating that the overall effectiveness may be limited.

However, maternal relationship security played a crucial role; mothers with high relationship anxiety but low avoidance benefited the most from home visiting, while those with high anxiety and avoidance experienced negative effects, suggesting the need for tailored approaches in home visiting services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal relationship security as a moderator of home visiting impacts on maternal psychosocial functioning. McFarlane, E., Burrell, L., Crowne, S., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

A typology of the potential outcomes of maternal-child home visits: a literature analysis. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

PREDICTORS OF SELF-REPORTED GAINS IN A RELATIONSHIP-BASED HOME-VISITING PROJECT FOR MOTHERS AFTER CHILDBIRTH. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Is home visiting an effective strategy? A meta-analytic review of home visiting programs for families with young children. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Parent satisfaction with sustained home visiting care for mothers and children: an integrative review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Mother and Home Visitor Emotional Well-Being and Alignment on Goals for Home Visiting as Factors for Program Engagement. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

WIDENING THE SCOPE OF SOCIAL SUPPORT: THE FLORIDA MATERNAL, INFANT, AND EARLY CHILDHOOD HOME VISITING PROGRAM. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Maternal relationship security as a moderator of home visiting impacts on maternal psychosocial functioning. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Health and safety intervention with first-time mothers. [2018]

9. Chile pubmed.ncbi.nlm.nih.gov

[Effectiveness of a home visit program for adolescent mothers and their children]. [2011]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Family Connects Dissemination to Four High-Poverty Rural Counties. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Social support and psychological functioning among high-risk mothers: the impact of the Baby Love Maternal Outreach Worker Program. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Targeted home visiting intervention: the impact on mother-infant relationships. [2019]