NCT03303326

Brief Summary

This study evaluates how Arab American women's cultural values and sexual health are related to their physical and emotional health. The study will also examine whether engaging in a sexual health interview affects women's physical and emotional health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2018

Completed
Last Updated

October 2, 2018

Status Verified

October 1, 2018

Enrollment Period

8 months

First QC Date

October 2, 2017

Last Update Submit

October 1, 2018

Conditions

Mental Health Wellness 1

Keywords

sexual health

Outcome Measures

Primary Outcomes (1)

  • Patient Health Questionnaire

    Physical symptoms

    Change from baseline to 5-week follow-up

Secondary Outcomes (7)

  • Brief Symptom Inventory

    Change from baseline to 5-week follow-up

  • Satisfaction with Life Scale

    Change from baseline to 5-week follow-up

  • Sexual Self-Schema Scale

    Change from baseline to 5-week follow-up

  • Sexual Self Disclosure Scale (Catania)

    Change from baseline to 5-week follow-up

  • Sexual Self Disclosure Scale (Herold & Way)

    Change from baseline to 5-week follow-up

  • +2 more secondary outcomes

Study Arms (2)

Immediate Interview

EXPERIMENTAL

A 60-minute interview about women's health conducted immediately after baseline questionnaires.

Behavioral: Immediate interview

Delayed Interview

NO INTERVENTION

The interview is conducted after the follow-up questionnaires are completed, rather than after baseline.

Interventions

Immediate interviewBEHAVIORAL

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.

Also known as: Women's Health Interview
Immediate Interview

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Arab American or Chaldean
  • Female
  • Age 18-35

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

Location

Study Officials

  • Mark Lumley, PhD

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 6, 2017

Study Start

September 28, 2017

Primary Completion

May 24, 2018

Study Completion

May 24, 2018

Last Updated

October 2, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)