Piloting ProHealth: A Program for Male Soldiers on Sex, Dating and Alcohol-Use at Fort Bragg

March 9, 2020 updated by: Womack Army Medical Center
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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • North Carolina
      • Fort Bragg, North Carolina, United States, 28310

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 26 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group
Participants receive three interventions: Surveys, Interviews, and Group Workshops
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.
These Motivational Interviews aim to promote change in behavior through open-ended questions, affirmations, and reflections.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 12 months
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
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.
Time Frame: 12 months
These Motivational Interviews aim to promote change through open-ended questions, affirmations, and reflections.
12 months
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.
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Cristobal Berry-Caban, PhD, Womack Army Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2018

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 9, 2017

First Posted (Actual)

June 12, 2017

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • RHC-A-18-011
  • W81XWH-15-2-0055 (Other Grant/Funding Number: Congressionally Directed Medical Research Programs)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will be housed on a secure server in the Department of Clinical Investigation at Womack Army Medical Center. All information will be treated as confidential material and access will be restricted to research staff.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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