Recruiting

Observational Study

Sponsor:

University of Notre Dame

Code:

NCT05428514

Conditions

Housing Problems

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Maternity Housing

Study Details

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.

Conditions

Housing Problems

Pregnancy Related

Study ID

NCT05428514

Start date

May 30, 2022

Status verified date

May, 2022

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Design

Enrollment

1048 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Maternity Home Bed

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

no intervention: Control

Referred to other services available in the community

Interventions

Maternity Housing

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

Primary outcome measure

  • Difference in rates of self-reported taking baby to term between treatment and control groups [ Time Frame: 1 year after approximate due date of baby ]
  • Difference in rates of self-reported retaining custody of baby between treatment and control groups [ Time Frame: 1 year after approximate due date of baby ]
  • Difference in rates of self-reported loneliness and depression between treatment and control groups [ Time Frame: 1 year after approximate due date of baby ]
  • Difference in rates of self-reported life satisfaction between treatment and control groups [ Time Frame: 1 year after approximate due date of baby ]
  • Difference in rates of self-reported sense of self-efficacy between treatment and control groups [ Time Frame: 1 year after approximate due date of baby ]
  • Difference in housing stability between treatment and control groups [ Time Frame: 1 year after approximate due date of baby ]
  • Difference in rates of continuum of care utilization between treatment and control groups [ Time Frame: 1 year after approximate due date of baby ]
  • Difference in employment rates between treatment and control groups [ Time Frame: 1 year after approximate due date of baby ]
  • Difference in safety-net utilization rates between treatment and control groups [ Time Frame: 1 year after approximate due date of baby ]
  • Difference in education rates between treatment and control groups [ Time Frame: 1 year after approximate due date of baby ]

Central Contacts and Locations

Central contacts

William Evans, PhD

5746317039wevans1@nd.edu

Vivian Crumlish, MEd

5746311669vcrumlis@nd.edu

Locations

University of Notre Dame

Recruiting

Notre Dame, Indiana, United States, 46556

Contacts

William Evans, PhD

574-631-7039wevans1@nd.edu

Vivian Crumlish, MEd

574-631-1669vcrumlis@nd.edu

More Information

Sponsor

University of Notre Dame

Last update posted

Jun 23, 2022

Last verified

May, 2022

Keywords

  • Housing
  • Homelessness
  • Substance-related disorders
  • Alcohol-related disorders
  • Pregnant Women

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Notre Dame on 2022-06-23.