Housing ProblemsNCT05428514
Evaluating the Impact of Emergency Maternity Housing
A study testing Maternity Housing in people with Housing Problems and Pregnancy Related, run by University of Notre Dame at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Housing Problems, Pregnancy Related
- What is being tested?
- Maternity Housing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,048 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2022to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Women who are not pregnant, men, pregnant women under 18, some homes exclude mothers who have other children currently in their care
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Notre Dame
Notre Dame, Indiana, 46556
William Evans, PhD, 574-631-7039, wevans1@nd.edu
Vivian Crumlish, MEd, 574-631-1669, vcrumlis@nd.edu
About this study
Official title: Evaluating the Impact of Emergency Maternity Housing on Mother and Child Well-being, Housing, and Employment
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.
Read the 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).
- Conditions
- Housing Problems, Pregnancy Related
- Being tested
- Maternity Housing
- Keywords
- Housing, Homelessness, Substance-related disorders, Alcohol-related disorders, Pregnant Women
- Medical subject headings
- Substance-Related Disorders, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternity HousingOther
Also called Emergency Maternity Housing
Receives a bed in the maternity home, wrap-around services, etc.
| Study group | Role | What they receive |
|---|---|---|
| Maternity Home Bed | Experimental | Receives a bed in the maternity home, wrap-around services, etc. Receives: Other: Maternity Housing |
| Control | No intervention | Referred to other services available in the community |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year after approximate due date of baby
Secondary outcomes (1)
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.
Measured: 1 year after approximate due date of baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start30 May 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Housing ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 1,048 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Notre Dame
- Sponsor type
- University, hospital or other
- Collaborators
- Bethlehem House, In My Shoes, Our Lady's Inn, USA, Aid for Women, Maggie's Place, USA
- Responsible party
- Principal investigator, William Evans, University of Notre Dame
- Investigators
- William Evans, PhD, Principal investigator, University of Notre DameAdrienne Sabety, PhD, Principal investigator, University of Notre DameJessica Brown, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428514
- Sponsor's protocol ID
- 22-04-7182
- Status last verified
- May 2022
- First submitted
- 29 May 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Emergency Maternity Housing on Mother and Child Well-being, Housing, and Employment
- ClinicalTrials.gov ID
- NCT05428514
- Acronym / sponsor ID
- 22-04-7182
- Conditions
- Housing Problems, Pregnancy Related
- Keywords
- Housing, Homelessness, Substance-related disorders, Alcohol-related disorders, Pregnant Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,048 participants (estimated)
- Lead sponsor
- University of Notre DameUniversity, hospital or other
- Collaborators
- Bethlehem House, In My Shoes, Our Lady's Inn, USA, Aid for Women, Maggie's Place, USA
- Study start
- 30 May 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Maternity Home Bed | Experimental | Other: Maternity HousingReceives a bed in the maternity home, wrap-around services, etc. |
| Control | No intervention | –Referred to other services available in the community |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Women who are not pregnant, men, pregnant women under 18, some homes exclude mothers who have other children currently in their care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternity HousingAlso: Emergency Maternity HousingReceives a bed in the maternity home, wrap-around services, etc. | Other | Maternity Home Bed |
Primary outcome
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
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
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.
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
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
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.
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.
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.
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.
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 secondary outcome
Difference in housing stability between treatment and control groups
Time frame: 1 year after approximate due date of baby
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Evans, PhD principal investigator
University of Notre Dame
Adrienne Sabety, PhD principal investigator
University of Notre Dame
Jessica Brown, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternity Housing in people with Housing Problems and Pregnancy Related, run by University of Notre Dame at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William Evans, PhD (5746317039, wevans1@nd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.