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

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ClinicalTrials.gov Identifier: NCT03184298
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : March 11, 2020
Sponsor:
Collaborators:
Rhode Island Hospital
University of North Carolina, Charlotte
Information provided by (Responsible Party):
Womack Army Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Sexual Assault and Rape Risk Behavior Alcohol Abuse Other: Surveys Other: Interviews Other: Group Discussions Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Piloting ProHealth: A Program for Male Soldiers on Sex, Dating and Alcohol-Use at Fort Bragg
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Group
Participants receive three interventions: Surveys, Interviews, and Group Workshops
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.

Other: Interviews
These Motivational Interviews aim to promote change in behavior through open-ended questions, affirmations, and reflections.

Other: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male, Active duty Soldier (Active-duty Army, Activated Reservist and National Guardsmen) at Fort Bragg, NC
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184298


Contacts
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Contact: Amber Lane, BSCR 2533072479 amber.r.lane2.ctr@mail.mil

Locations
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United States, North Carolina
Womack Army Medical Center Recruiting
Fort Bragg, North Carolina, United States, 28310
Contact: Amber Lane, BSCR    910-907-1042    amber.r.lane2.ctr@mail.mil   
Sponsors and Collaborators
Womack Army Medical Center
Rhode Island Hospital
University of North Carolina, Charlotte
Investigators
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Principal Investigator: Cristobal Berry-Caban, PhD Womack Army Medical Center
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Responsible Party: Womack Army Medical Center
ClinicalTrials.gov Identifier: NCT03184298    
Other Study ID Numbers: RHC-A-18-011
W81XWH-15-2-0055 ( Other Grant/Funding Number: Congressionally Directed Medical Research Programs )
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Womack Army Medical Center:
Military Personnel
Sexual Assault
Military Sexual Trauma
Alcohol and Substance Abuse
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders