Piloting ProHealth: A Program for Male Soldiers on Sex, Dating and Alcohol-Use at Fort Bragg
Primary Purpose
Sexual Assault and Rape, Risk Behavior, Alcohol Abuse
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surveys
Interviews
Group Discussions
Sponsored by
About this trial
This is an interventional prevention trial for Sexual Assault and Rape focused on measuring Military Personnel, Sexual Assault, Military Sexual Trauma, Alcohol and Substance Abuse
Eligibility 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
Sites / Locations
- Womack Army Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Group
Arm Description
Participants receive three interventions: Surveys, Interviews, and Group Workshops
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03184298
First Posted
June 2, 2017
Last Updated
March 9, 2020
Sponsor
Womack Army Medical Center
Collaborators
Rhode Island Hospital, University of North Carolina, Charlotte
1. Study Identification
Unique Protocol Identification Number
NCT03184298
Brief Title
Piloting ProHealth: A Program for Male Soldiers on Sex, Dating and Alcohol-Use at Fort Bragg
Official Title
Piloting ProHealth: A Program for Male Soldiers on Sex, Dating and Alcohol-Use at Fort Bragg
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Womack Army Medical Center
Collaborators
Rhode Island Hospital, University of North Carolina, Charlotte
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Assault and Rape, Risk Behavior, Alcohol Abuse
Keywords
Military Personnel, Sexual Assault, Military Sexual Trauma, Alcohol and Substance Abuse
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group
Arm Type
Other
Arm Description
Participants receive three interventions: Surveys, Interviews, and Group Workshops
Intervention Type
Other
Intervention Name(s)
Surveys
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Interviews
Intervention Description
These Motivational Interviews aim to promote change in behavior through open-ended questions, affirmations, and reflections.
Intervention Type
Other
Intervention Name(s)
Group Discussions
Intervention Description
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 Measure Information:
Title
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.
Description
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.
Time Frame
12 months
Title
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.
Description
These Motivational Interviews aim to promote change through open-ended questions, affirmations, and reflections.
Time Frame
12 months
Title
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.
Description
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.
Time Frame
12 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male, Active duty Soldier (Active-duty Army, Activated Reservist and National Guardsmen) at Fort Bragg, NC
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amber Lane, BSCR
Phone
2533072479
Email
amber.r.lane2.ctr@mail.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristobal Berry-Caban, PhD
Organizational Affiliation
Womack Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Womack Army Medical Center
City
Fort Bragg
State/Province
North Carolina
ZIP/Postal Code
28310
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber Lane, BSCR
Phone
910-907-1042
Email
amber.r.lane2.ctr@mail.mil
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Piloting ProHealth: A Program for Male Soldiers on Sex, Dating and Alcohol-Use at Fort Bragg
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