- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05428514
Evaluating the Impact of Emergency Maternity Housing
Evaluating the Impact of Emergency Maternity Housing on Mother and Child Well-being, Housing, and Employment
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: William Evans, PhD
- Número de teléfono: 5746317039
- Correo electrónico: wevans1@nd.edu
Copia de seguridad de contactos de estudio
- Nombre: Vivian Crumlish, MEd
- Número de teléfono: 5746311669
- Correo electrónico: vcrumlis@nd.edu
Ubicaciones de estudio
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Indiana
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Notre Dame, Indiana, Estados Unidos, 46556
- Reclutamiento
- University of Notre Dame
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Contacto:
- William Evans, PhD
- Número de teléfono: 574-631-7039
- Correo electrónico: wevans1@nd.edu
-
Contacto:
- Vivian Crumlish, MEd
- Número de teléfono: 574-631-1669
- Correo electrónico: vcrumlis@nd.edu
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: Control
Referido a otros servicios disponibles en la comunidad
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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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Difference in rates of self-reported taking baby to term between treatment and control groups
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Difference in housing stability between treatment and control groups
Periodo de tiempo: 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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Adrienne Sabety, PhD, University of Notre Dame
- Investigador principal: William Evans, PhD, University of Notre Dame
- Investigador principal: Jessica Brown, PhD, University of South Carolina
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 22-04-7182
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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