NCT05428514

Brief Summary

Moms will call and agencies will determine if she is eligible based on basic criteria. If she is eligible, the agency will send her an intake application link to complete, which includes a consent form. After completing the survey, if she is still eligible, she will be placed on a waitlist for services. When a bed becomes available in an individual agency, the agency will call two moms at the top of the waitlist, conduct in-person interviews to confirm eligibility and good fit. They will use a computer to randomly assign one to treatment and one to control. Agency will let moms know of their status and will allow the treatment mom to move in. Moms in treatment and control will be surveyed approximately one year post the mother's reported due date of the child.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,048

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 29, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 23, 2022

Status Verified

May 1, 2022

Enrollment Period

3.5 years

First QC Date

May 29, 2022

Last Update Submit

June 17, 2022

Conditions

Housing ProblemsPregnancy Related

Keywords

HousingHomelessnessSubstance-related disordersAlcohol-related disordersPregnant Women

Outcome Measures

Primary Outcomes (10)

  • Difference in rates of self-reported taking baby to term between treatment and control groups

    The research team will use self-reported rates of taking the baby to term between treatment and control groups

    1 year after approximate due date of baby

  • Difference in rates of self-reported retaining custody of baby between treatment and control groups

    The research team will use survey data to quantify the impact of receiving a bed in the maternity home on self-reported retaining custody of the baby

    1 year after approximate due date of baby

  • Difference in rates of self-reported loneliness and depression between treatment and control groups

    The research team will use survey data to quantify the impact of receiving a bed in the maternity home on self-reported loneliness and depression levels.

    1 year after approximate due date of baby

  • Difference in rates of self-reported life satisfaction between treatment and control groups

    The research team will use survey data to quantify the impact of receiving a bed in the maternity home on self-reported life satisfaction

    1 year after approximate due date of baby

  • Difference in rates of self-reported sense of self-efficacy between treatment and control groups

    The research team will use survey data to quantify the impact of receiving a bed in the maternity home on self-reported sense of self-efficacy

    1 year after approximate due date of baby

  • Difference in housing stability between treatment and control groups

    The research team will use self-reported independent living status and whether the mom has a mortgage or lease in her own name at the time of follow to quantify the impact of receiving a bed in the maternity home on housing stability.

    1 year after approximate due date of baby

  • Difference in rates of continuum of care utilization between treatment and control groups

    The research team will use mother's interactions with other local service agencies involved in the locality's continuum of care system to quantify the impact of receiving a bed in the maternity home on continuum of care interactions.

    1 year after approximate due date of baby

  • Difference in employment rates between treatment and control groups

    The research team will use survey data to quantify the impact of receiving a bed in the maternity home on self-reported employment.

    1 year after approximate due date of baby

  • Difference in safety-net utilization rates between treatment and control groups

    The research team will use survey data to quantify the impact of receiving a bed in the maternity home on self-reported amount of welfare received, for example TANF, WIC, SNAP, etc.

    1 year after approximate due date of baby

  • Difference in education rates between treatment and control groups

    The research team will use survey data to quantify the impact of receiving a bed in the maternity home on self-reported education level.

    1 year after approximate due date of baby

Secondary Outcomes (1)

  • Difference in housing stability between treatment and control groups

    1 year after approximate due date of baby

Study Arms (2)

Maternity Home Bed

EXPERIMENTAL

Receives a bed in the maternity home, wrap-around services, etc.

Other: Maternity Housing

Control

NO INTERVENTION

Referred to other services available in the community

Interventions

Maternity HousingOTHER

Receives a bed in the maternity home, wrap-around services, etc.

Also known as: Emergency Maternity Housing
Maternity Home Bed

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Each home has their own eligibility criteria. The main three criteria common across homes are that a woman must be at least 18 years old, experiencing housing instability, and pregnant. No home has an income standard because, by definition, applicants are in a precarious housing situation so most women are low-income. Each home does have slightly different eligibility criteria. For example, some homes allow other children to come with her into the home, while other homes do not. Some homes require a background check and might allow a woman to enter the home anyway depending on the prior offense.

You may not qualify if:

  • Women who are not pregnant, men, pregnant women under 18, some homes exclude mothers who have other children currently in their care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Notre Dame

Notre Dame, Indiana, 46556, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related DisordersAlcohol-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • William Evans, PhD

    University of Notre Dame

    PRINCIPAL INVESTIGATOR

  • Adrienne Sabety, PhD

    University of Notre Dame

    PRINCIPAL INVESTIGATOR

  • Jessica Brown, PhD

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Central Study Contacts

William Evans, PhD

CONTACT

5746317039wevans1@nd.edu

Vivian Crumlish, MEd

CONTACT

5746311669vcrumlis@nd.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Clients will be consented on a baseline application. After the application, clients will be on a waitlist. When a bed is available, the agency will bring the top two moms on the waitlist in for an in person interview to confirm they are good fits for the home. The agency will then use a computer to randomly assign one mom to treatment (receiving the bed in the home) and one mom to control (referrals to other services).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. William Evans, Keough Hesburgh Professor of Economics

Study Record Dates

First Submitted

May 29, 2022

First Posted

June 23, 2022

Study Start

May 30, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

June 23, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

We plan to create a de-identified dataset of participant data, which we will make available for other researchers. This dataset will contain the data necessary to replicate the analysis detailed in publications resulting from the study. We will only share data in a manner consistent with data sharing agreements which we establish with data providers. These data sharing agreements are still in process, so while we plan to share de-identified data at this time, we will only do so if our data sharing agreements allow it.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
We will make data available when we release a publication resulting from the study. There will not be an end date for when data will be available.
Access Criteria
We will make our dataset available to the general public by posting it on the website for the Inter-University Consortium for Political and Social Research (ICPSR).

Locations

US(1)