Sexual Assault and RapeNCT03184298
Piloting ProHealth: A Program for Male Soldiers on Sex, Dating and Alcohol-Use at Fort Bragg
A study testing Surveys, Interviews and Group Discussions in people with Sexual Assault and Rape and Risk Behavior, run by Womack Army Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Assault and Rape, Risk Behavior, Alcohol Abuse
- What is being tested?
- Surveys, Interviews and Group Discussions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Screen positive for alcohol withdrawal on the ASWC (score of > 23)
- Report or indicate suicidal or homicidal ideation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Womack Army Medical Center
Fort Bragg, North Carolina, 28310
Amber Lane, BSCR, 910-907-1042, amber.r.lane2.ctr@mail.mil
About this study
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.
Read the 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.
- Conditions
- Sexual Assault and Rape, Risk Behavior, Alcohol Abuse
- Being tested
- Surveys, Interviews, Group Discussions
- Keywords
- Military Personnel, Sexual Assault, Military Sexual Trauma, Alcohol and Substance Abuse
- Medical subject headings
- Risk-Taking, Alcoholism, Military Sexual Trauma, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
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.
InterviewsOther
These Motivational Interviews aim to promote change in behavior through open-ended questions, affirmations, and reflections.
Group DiscussionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group | Other | Participants receive three interventions: Surveys, Interviews, and Group Workshops Receives: Other: Surveys; Other: Interviews; Other: Group Discussions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
These Motivational Interviews aim to promote change through open-ended questions, affirmations, and reflections.
Measured: 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.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start23 Apr 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual Assault and RapeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Womack Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Rhode Island Hospital, University of North Carolina, Charlotte
- Responsible party
- Sponsor
- Investigators
- Cristobal Berry-Caban, PhD, Principal investigator, Womack Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184298
- Sponsor's protocol ID
- RHC-A-18-011
- Other IDs
- W81XWH-15-2-0055
- Status last verified
- Mar 2020
- First submitted
- 2 Jun 2017
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting ProHealth: A Program for Male Soldiers on Sex, Dating and Alcohol-Use at Fort Bragg
- ClinicalTrials.gov ID
- NCT03184298
- Acronym / sponsor ID
- RHC-A-18-011
- Conditions
- Sexual Assault and Rape, Risk Behavior, Alcohol Abuse
- Keywords
- Military Personnel, Sexual Assault, Military Sexual Trauma, Alcohol and Substance Abuse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Womack Army Medical CenterUS federal agency
- Collaborators
- Rhode Island Hospital, University of North Carolina, Charlotte
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 12 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | Other | Other: Surveys, Other: Interviews, Other: Group DiscussionsParticipants receive three interventions: Surveys, Interviews, and Group Workshops |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Screen positive for alcohol withdrawal on the ASWC (score of > 23)
- Report or indicate suicidal or homicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveysThe 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 | Group |
| InterviewsThese Motivational Interviews aim to promote change in behavior through open-ended questions, affirmations, and reflections. | Other | Group |
| Group DiscussionsThe 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. | Other | Group |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristobal Berry-Caban, PhD principal investigator
Womack Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surveys, Interviews and Group Discussions in people with Sexual Assault and Rape and Risk Behavior, run by Womack Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amber Lane, BSCR (2533072479, amber.r.lane2.ctr@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.