- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03303326
Arab American Women's Health Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Wayne State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Arab American or Chaldean
- Female
- Age 18-35
Exclusion Criteria:
- Non-English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate Interview
A 60-minute interview about women's health conducted immediately after baseline questionnaires.
|
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.
Other Names:
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No Intervention: Delayed Interview
The interview is conducted after the follow-up questionnaires are completed, rather than after baseline.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire
Time Frame: Change from baseline to 5-week follow-up
|
Physical symptoms
|
Change from baseline to 5-week follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Symptom Inventory
Time Frame: Change from baseline to 5-week follow-up
|
Psychological symptoms
|
Change from baseline to 5-week follow-up
|
Satisfaction with Life Scale
Time Frame: Change from baseline to 5-week follow-up
|
Satisfaction with life
|
Change from baseline to 5-week follow-up
|
Sexual Self-Schema Scale
Time Frame: Change from baseline to 5-week follow-up
|
Sexual self-schemas
|
Change from baseline to 5-week follow-up
|
Sexual Self Disclosure Scale (Catania)
Time Frame: Change from baseline to 5-week follow-up
|
Self-reported ease or difficulty with disclosing information about sexuality
|
Change from baseline to 5-week follow-up
|
Sexual Self Disclosure Scale (Herold & Way)
Time Frame: Change from baseline to 5-week follow-up
|
Degree of past sexual disclosure
|
Change from baseline to 5-week follow-up
|
Female Sexual Function Index
Time Frame: Change from baseline to 5-week follow-up
|
Female sexual function
|
Change from baseline to 5-week follow-up
|
Sexual Satisfaction Scale for Women
Time Frame: Change from baseline to 5-week follow-up
|
Sexual satisfaction
|
Change from baseline to 5-week follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Lumley, PhD, Wayne State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Other Study ID Numbers
- 064917B3E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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