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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03184298
Other study ID # RHC-A-18-011
Secondary ID W81XWH-15-2-0055
Status Recruiting
Phase N/A
First received
Last updated
Start date April 23, 2018
Est. completion date December 31, 2020

Study information

Verified date March 2020
Source Womack Army Medical Center
Contact Amber Lane, BSCR
Phone 2533072479
Email amber.r.lane2.ctr@mail.mil
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed project will provide data concerning dating and sexual interactions that occur on Fort Bragg, North Carolina, in addition to piloting a sexual assault prevention program through the use of social norms and bystander intervention concepts. The investigators will be able to use data and feedback gained from this research to help reduce rates of sexual assault in the military by providing a sexual assault prevention program tailored to at risk male Soldiers that can be disseminated across military posts.


Description:

Research has shown that one beneficial preliminary step to sexual assault prevention is the examination of a population's social norms pertaining to sex, dating, and alcohol- use. Studies show that the social norms surrounding these behaviors can be risk factors that increase the likelihood that certain high-risk men will perpetrate sexual assault.

Among college-age men, research on social norms has been used to inform the development of a sexual assault prevention program that positively impacts high-risk men. A hallmark of this approach is its exploration of the climate of a given population with regard to sex, dating and alcohol-use, and its use of data gathered to inform the development of a sexual assault program. Researchers have yet to study the effectiveness of this approach in the U.S. Army.

It has been well documented that sexual assault in the Army carries a significant threat to the readiness of the force. As such, the Army continues to make strong and laudable efforts to reduce sexual assault. However, there remains a need to better understand how young at-risk men behave in the social situations where sexual assault can occur and what they subjectively believe about these behaviors in order to effectively reduce perpetration.

In order to fill this gap, the investigators propose to implement a sexual assault prevention program by using social norms and bystander approach concepts via surveys, interviews and group workshops. The data and feedback from this research have the potential to produce insight that could help leaders and the investigators more effectively promote health in male Soldiers' dating and sexual relationships.


Recruitment information / eligibility

Status Recruiting
Enrollment 82
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 26 Years
Eligibility Inclusion Criteria:

- Male

- Active-duty Soldier (Active-duty Army, Activated Reservist or National Guardsmen) at Fort Bragg, NC

- Between the ages of 18 and 26; usage of "18-26" means at least 18 years of age but less than 27 years of age

- Reported having engaged in oral, vaginal, or anal sex within previous 4 months

- Able to speak and comprehend English sufficiently to complete the study procedures

- Indicate at risk-drinking via an AUDIT-C score >4

Exclusion Criteria:

- Screen positive for alcohol withdrawal on the ASWC (score of > 23)

- Report or indicate suicidal or homicidal ideation

Study Design


Intervention

Other:
Surveys
The purpose of the surveys is to collect quantitative data to determine the relative impact of the intervention program on participants' sexual behaviors and alcohol use.
Interviews
These Motivational Interviews aim to promote change in behavior through open-ended questions, affirmations, and reflections.
Group Discussions
The purpose of the group workshop is to create discussions surrounding perceived and collective social norms found among male soldiers that have been connected to sexual aggression. These discussions are used to promote bystander intervention among participants and help identify the prosocial attitudes that may be more common than previously perceived.

Locations

Country Name City State
United States Womack Army Medical Center Fort Bragg North Carolina

Sponsors (3)

Lead Sponsor Collaborator
Womack Army Medical Center Rhode Island Hospital, University of North Carolina, Charlotte

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The feasibility and impact of a sexual assault prevention program on active duty male Army Service members, Activated Reservists, and Activated National Guardsmen as assessed by surveys. The purpose of the surveys is to collect quantitative data to determine the relative impact of the intervention program on participants' sexual behaviors and alcohol use. 12 months
Primary The feasibility and impact of a sexual assault prevention program on active duty male Army Service members, Activated Reservists, and Activated National Guardsmen as assessed by individual Motivation Interviews. These Motivational Interviews aim to promote change through open-ended questions, affirmations, and reflections. 12 months
Primary The feasibility and impact of a sexual assault prevention program on active duty male Army Service members, Activated Reservists, and Activated National Guardsmen as assessed by group workshops. The purpose of the group workshops is to create discussions surrounding perceived and collective social norms found among male soldiers that have been connected to sexual aggression. These discussions are used to promote bystander intervention among participants and help identify the attitudes that may be more common than previously perceived. 12 months
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