- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03303326
Arab American Women's Health Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Sexuality is an important aspect of health, in part because emotional conflicts over sexuality as well as unwanted sexual experiences can impact physical and psychological health; yet no studies have examined sexual health among Arab American women in the U.S. These women face the task of negotiating their heritage culture and the American culture in which they reside. This may result in bicultural identity conflict for some women as they try to negotiate these two identities, which may have implications for sexuality and sexual health due to the two cultures' disparate views on sexuality. Confidential discussion of these sensitive topics with a knowledgeable interviewer may yield beneficial effects.
The overall goal of the current study is to fill the gap in the literature on Arab American sexual health by examining how sexual health is related to physical and psychological health. This will be accomplished using both: a) correlational findings about sexual, physical, and psychological health from information gathered through self-report questionnaires and a 60-minute women's health interview; and b) an experimental test of the effects of the women's health interview on physical and psychological health. A sample of young adult Arab American women will be assessed at baseline via questionnaires for various constructs (sexual attitudes, cultural and religious identity, and physical and mental health), and then randomized to either an immediate or delayed health interview, with a 5-week follow-up reassessment.
It is hypothesized that lower sexual well-being, negative sexual self-schemas, and unwanted sexual experiences will correlate with more somatic and psychological health symptoms and lower satisfaction with life. It is also hypothesized that participants who have the immediate interview will report greater reduction in somatic and psychological symptoms and a greater willingness to discuss sexual health with medical providers compared to participants who are not interviewed (i.e., have a delayed interview after follow-up assessment).
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Michigan
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Detroit, Michigan, Estados Unidos, 48201
- Wayne State University
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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:
- Arab American or Chaldean
- Female
- Age 18-35
Exclusion Criteria:
- Non-English speaking
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Immediate Interview
A 60-minute interview about women's health conducted immediately after baseline questionnaires.
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A women's health interview that obtains information about physical, mental, and sexual health, particularly relatively private sexual health-related attitudes and experiences, as well as conflicts and stress related to sexuality.
Otros nombres:
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Sin intervención: Delayed Interview
The interview is conducted after the follow-up questionnaires are completed, rather than after baseline.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Patient Health Questionnaire
Periodo de tiempo: Change from baseline to 5-week follow-up
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Physical symptoms
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Change from baseline to 5-week follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Brief Symptom Inventory
Periodo de tiempo: Change from baseline to 5-week follow-up
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Psychological symptoms
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Change from baseline to 5-week follow-up
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Satisfaction with Life Scale
Periodo de tiempo: Change from baseline to 5-week follow-up
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Satisfaction with life
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Change from baseline to 5-week follow-up
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Sexual Self-Schema Scale
Periodo de tiempo: Change from baseline to 5-week follow-up
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Sexual self-schemas
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Change from baseline to 5-week follow-up
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Sexual Self Disclosure Scale (Catania)
Periodo de tiempo: Change from baseline to 5-week follow-up
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Self-reported ease or difficulty with disclosing information about sexuality
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Change from baseline to 5-week follow-up
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Sexual Self Disclosure Scale (Herold & Way)
Periodo de tiempo: Change from baseline to 5-week follow-up
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Degree of past sexual disclosure
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Change from baseline to 5-week follow-up
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Female Sexual Function Index
Periodo de tiempo: Change from baseline to 5-week follow-up
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Female sexual function
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Change from baseline to 5-week follow-up
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Sexual Satisfaction Scale for Women
Periodo de tiempo: Change from baseline to 5-week follow-up
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Sexual satisfaction
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Change from baseline to 5-week follow-up
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mark Lumley, PhD, Wayne State University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- 064917B3E
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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