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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05428514
Other study ID # 22-04-7182
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 30, 2022
Est. completion date December 1, 2025

Study information

Verified date May 2022
Source University of Notre Dame
Contact William Evans, PhD
Phone 5746317039
Email wevans1@nd.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The process begins when an expectant month calls a home seeking housing. The maternity home caseworker will ask basic screening questions to determine eligibility. Those found ineligible are referred elsewhere. If the mom is eligible, the caseworker will send her a link to an online application asking a variety of questions surrounding her current housing and employment, health and mental health, other children, criminal justice involvement, etc. The application will include a brief consent form asking for permission to use her information. She will have the option of consenting or not. When she submits her response, the caseworker will be able to review her answers. If there are any answers that would make the mom ineligible at this point, the caseworker will call her and refer her to other local services. If she is still a good fit, the caseworker will call her and let her know that she is eligible but that they don't have any open beds, and that she will be put on a waitlist for the next available bed. When a bed becomes available, a caseworker will call the top two moms on the waitlist and schedule a time for an in-person interview. They will conduct both interviews to confirm eligibility. After the interview, caseworkers might convene at the home to discuss whether the moms are good fits for group living (for example, the mothers are sometimes unwilling to abide by house rules and they might indicate hesitancy during an interview). If one is not a good fit, the caseworker will let her know she is ineligible and bring in the next mom on the list for an interview. Once two moms are found eligible, the caseworkers will put their names into a separate survey form, which on the backend will randomly assign one to treatment and one to control. The caseworker will call each mom back and let her know if they are going to be able to help her based on her randomization status. Control moms will be referred to other local services. Treatment moms will schedule a time to move in. Both consented and unconsented moms will be randomized the same - having the same odds of receiving services. Note that three of the five homes will utilize the procedure above. The fourth and fifth homes will complete the same process up to the waitlist stage. Once a bed is available, the caseworker will call the top two moms on the waitlist to confirm they are still interested, then they will randomize them and let them know their status. Only the treatment mom will be brought in for an interview since this home is confident they will be able to determine eligibility based off of the phone and survey application screen and only need the interview to determine services for moms who will actually move into the home. All moms will complete a follow up survey about one year after the estimated birth of the child (as reported as the due date at baseline).


Recruitment information / eligibility

Status Recruiting
Enrollment 1048
Est. completion date December 1, 2025
Est. primary completion date December 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Maternity Housing
Receives a bed in the maternity home, wrap-around services, etc.

Locations

Country Name City State
United States University of Notre Dame Notre Dame Indiana

Sponsors (6)

Lead Sponsor Collaborator
University of Notre Dame Aid for Women, Bethlehem House, In My Shoes, Maggie's Place, USA, Our Lady's Inn, USA

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Difference in housing stability between treatment and control groups The research team will explore using information from Infutor Data Solutions to also capture address changes and will compare these findings with the self-reported information about housing. Infutor data will only be an exploratory outcome. 1 year after approximate due date of baby
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