- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03184298
Piloting ProHealth: A Program for Male Soldiers on Sex, Dating and Alcohol-Use at Fort Bragg
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amber Lane, BSCR
- Phone Number: 2533072479
- Email: amber.r.lane2.ctr@mail.mil
Study Locations
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-
North Carolina
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Fort Bragg, North Carolina, United States, 28310
- Recruiting
- Womack Army Medical Center
-
Contact:
- Amber Lane, BSCR
- Phone Number: 910-907-1042
- Email: amber.r.lane2.ctr@mail.mil
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Cristobal Berry-Caban, PhD, Womack Army Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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