NCT03184298

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

April 23, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

2.7 years

First QC Date

June 2, 2017

Last Update Submit

March 9, 2020

Conditions

Keywords

Military PersonnelSexual AssaultMilitary Sexual TraumaAlcohol and Substance Abuse

Outcome Measures

Primary Outcomes (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 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.

    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.

    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.

    12 months

Study Arms (1)

Group

OTHER

Participants receive three interventions: Surveys, Interviews, and Group Workshops

Other: SurveysOther: InterviewsOther: Group Discussions

Interventions

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.

Group

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

Group

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.

Group

Eligibility Criteria

Age18 Years - 26 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale, Active duty Soldier (Active-duty Army, Activated Reservist and National Guardsmen) at Fort Bragg, NC
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Screen positive for alcohol withdrawal on the ASWC (score of \> 23)
  • Report or indicate suicidal or homicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

RECRUITING

MeSH Terms

Conditions

Risk-TakingAlcoholismMilitary Sexual TraumaSubstance-Related Disorders

Interventions

Surveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

BehaviorAlcohol-Related DisordersChemically-Induced DisordersMental DisordersSexual TraumaStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Cristobal Berry-Caban, PhD

    Womack Army Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2017

First Posted

June 12, 2017

Study Start

April 23, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 11, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

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.

Locations