- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05428514
Evaluating the Impact of Emergency Maternity Housing
Evaluating the Impact of Emergency Maternity Housing on Mother and Child Well-being, Housing, and Employment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: William Evans, PhD
- Phone Number: 5746317039
- Email: wevans1@nd.edu
Study Contact Backup
- Name: Vivian Crumlish, MEd
- Phone Number: 5746311669
- Email: vcrumlis@nd.edu
Study Locations
-
-
Indiana
-
Notre Dame, Indiana, United States, 46556
- Recruiting
- University of Notre Dame
-
Contact:
- William Evans, PhD
- Phone Number: 574-631-7039
- Email: wevans1@nd.edu
-
Contact:
- Vivian Crumlish, MEd
- Phone Number: 574-631-1669
- Email: vcrumlis@nd.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Referred to other services available in the community
|
|
Experimental: Maternity Home Bed
Receives a bed in the maternity home, wrap-around services, etc.
|
Receives a bed in the maternity home, wrap-around services, etc.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
Time Frame: 1 year after approximate due date of baby
|
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
Time Frame: 1 year after approximate due date of baby
|
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
Time Frame: 1 year after approximate due date of baby
|
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
Time Frame: 1 year after approximate due date of baby
|
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
Time Frame: 1 year after approximate due date of baby
|
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
Time Frame: 1 year after approximate due date of baby
|
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
Time Frame: 1 year after approximate due date of baby
|
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
Time Frame: 1 year after approximate due date of baby
|
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
Time Frame: 1 year after approximate due date of baby
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in housing stability between treatment and control groups
Time Frame: 1 year after approximate due date of baby
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Adrienne Sabety, PhD, University of Notre Dame
- Principal Investigator: William Evans, PhD, University of Notre Dame
- Principal Investigator: Jessica Brown, PhD, University of South Carolina
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-04-7182
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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