NCT01692067

Brief Summary

The purpose of this study is to determine potential risk factors for physical and sexual assault in regular military women (as opposed to Reserve and National Guard). In addition, this study seeks to determine associations between service women's violence exposures and: current physical and mental health status (e.g. PTSD), and access to and use of DoD, DVA and civilian healthcare.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
871

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2011

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

July 19, 2019

Status Verified

July 1, 2019

Enrollment Period

3.8 years

First QC Date

July 28, 2011

Last Update Submit

July 18, 2019

Conditions

Keywords

RapeWomenMilitaryVeteransPost-traumatic Stress DisorderTraumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Organizational, situational, and individual risk factors for physical and sexual assault in women who have or currently serving in active duty Regular Military in OIF/OEF by deployment status.

    Months 28-42 of grant

Secondary Outcomes (6)

  • Traumatic brain injury

    Months 28-42 of grant

  • Current internal (e.g. PTSD) and external barriers (e.g. access to care factors)to health services

    Months 28-42 of grant

  • Identification and description of differences between Regular Military and Reserve/National Guard service women for each of these aims (building on currently funded grant).

    Months 28-42 of grant

  • PTSD

    Months 28-42 of Grant

  • Current medical health, including reproductive health

    Months 28-42 of grant

  • +1 more secondary outcomes

Study Arms (4)

D0

Not deployed

D1

Deployed to combat-related regions once

D2

Deployed to combat related regions more than once

D3

Deployed outside of the continental US but not to combat related regions

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women and Men who have or are currently serving in the USA regular military.

You may qualify if:

  • Focus Group:
  • Men or women who have or are currently active duty regular military (RM) of OIF/OEF service eras (10/7/01- present)
  • Interview phase:
  • Women, who have or are currently serving active duty RM during OIF/OEF service eras

You may not qualify if:

  • Focus Group:
  • Disabilities that render incapable of hearing
  • Comprehending
  • Communicating in a group or inhibit travel to focus group
  • Interview phase:
  • Disabilities that render incapable of hearing
  • Comprehending
  • Communicating independently with interviewers by telephone
  • Not having telephone and unable to access a nearby VA or other possible resource to contact toll free number.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Anne G. Sadler, Ph.D.; VAMC

Iowa City, Iowa, 52246, United States

Location

Iowa City VAMC

Iowa City, Iowa, 52246, United States

Location

MeSH Terms

Conditions

Sexual TraumaStress Disorders, Post-TraumaticBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Anne G Sadler, Ph.D.

    US Department of Veterans Affairs

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CADRE Core Investigator

Study Record Dates

First Submitted

July 28, 2011

First Posted

September 25, 2012

Study Start

April 1, 2009

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

July 19, 2019

Record last verified: 2019-07

Locations