College Health Center-based Alcohol and Sexual Violence Intervention (GIFTSS)
Primary Purpose
Sexual Assault, Alcohol Consumption, Intimate Partner Violence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GIFTSS
Brief alcohol use intervention
Sponsored by

About this trial
This is an interventional prevention trial for Sexual Assault focused on measuring Sexual assault, Alcohol consumption, Intimate partner violence
Eligibility Criteria
Inclusion Criteria:
- Ages 18-24
- Able to read English
- Seeking care at the college health center for any reason
Exclusion Criteria:
- Younger than 18 or older than 24 years
- Not seeking care at the college health center
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Participants will receive the GIFTSS intervention provided by college health center staff and clinicians
Participants will receive a brief alcohol use reduction intervention based on NIAAA guidelines provided by college health center staff and clinicians
Outcomes
Primary Outcome Measures
Change in recognition of alcohol-related sexual violence and sexual risk from baseline to follow up
Changes in overall mean knowledge score measuring recognition of what constitutes sexual violence and the role of alcohol in risk for sexual violence comparing baseline and follow up
Secondary Outcome Measures
Change in self-efficacy to use harm reduction strategies
Post-intervention levels of self-efficacy to use specified harm reduction strategies to reduce risk for sexual violence adjusting for baseline general self-efficacy
Change in knowledge of sexual violence related services from baseline to follow up
Knowing about specified sexual violence related services comparing baseline and follow up summary scores
Change in self-efficacy to use sexual violence related services
Changes in mean score measuring self-efficacy to use violence related services comparing baseline and follow up
Change in intentions to intervene from baseline to follow up
Proclivity to intervene when witnessing disrespectful and harmful behaviors among peers comparing baseline and follow up mean scores on a scale assessing likelihood of trying to stop harmful behaviors among peers
Change in positive bystander behaviors from baseline to follow up
Assessment of recent positive bystander behavior in students when witnessing disrespectful and harmful behaviors among peers comparing baseline and follow up summary scores. Students report if they have witnessed peers' abusive behaviors in recent months and if witnessed, how they responded (whether they intervened to interrupt the behavior)
Change in recognition of sexual coercion from baseline to follow up
Changes in mean score measuring recognition of what constitutes sexual coercion comparing baseline and follow up
Change in self-efficacy to obtain sexual consent
Changes in mean score assessing self-efficacy to obtain sexual consent comparing baseline and follow up
Full Information
NCT ID
NCT02355470
First Posted
January 30, 2015
Last Updated
April 27, 2018
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT02355470
Brief Title
College Health Center-based Alcohol and Sexual Violence Intervention
Acronym
GIFTSS
Official Title
GIFTSS (Giving Information for Trauma Support and Safety): A College Health Center-based Alcohol and Sexual Violence Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
April 27, 2018 (Actual)
Study Completion Date
April 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will offer the first formal assessment for sexual violence (SV) in the college student health center setting, developed for a high risk group of college students, and is designed to facilitate patient and provider comfort in discussing sexual violence and related abusive experiences (including the role of alcohol) via semi-scripted screening tools. The intervention specifically involves the training of all clinical staff (health educators, counselors, medical assistants, nurses, and clinicians) to deliver a universal education and brief counseling intervention titled GIFTSS (Giving Information for Trauma Support and Safety) to all clients seeking college health services integrated into usual clinical practice, provide universal education about SV regardless of disclosure, counsel clients on harm reduction strategies to reduce risk for SV, and provide supported referrals to sexual assault advocates, with the goal of reducing SV among college students.
Detailed Description
This is a stakeholder-engaged longitudinal study to test, via a 2-armed cluster randomized controlled trial , a brief harm reduction intervention to reduce risk for sexual violence among male and female college students ages 18-24 receiving care from college student health services (K = 28 colleges; baseline N = 2295). Sexual violence (SV) (including sexual coercion, non-consensual sexual contact, and rape) is common among college women, and over three quarters of women who have been sexually assaulted report that the first of such experiences occurred before the age of 25. Alcohol-related SV, in particular, is highly prevalent on college campuses, with about half of sexual assault cases occurring in the context of victim and/or perpetrator intoxication. Multiple pathways have been implicated in this association between alcohol and SV, with social norms regarding alcohol consumption and expectations for SV facilitating both the occurrence and underreporting of such violence. College student health centers remain an untapped setting to reach youth for both SV prevention and intervention. This study draws on several intervention studies by the investigative team, integrating successful components from each: 1) the bystander approach in which individuals are taught skills as active interveners in SV prevention rather than responding with apathy or tolerance is an effective strategy for promoting change within social contexts; 2) universal education about SV regardless of disclosure in the clinical setting can result in increased recognition of SV and use of relevant services; and 3) harm reduction strategies introduced by clinicians can increase intentions to use strategies to help oneself and friends that increase safety. The brief counseling intervention uses a palm-size educational card with information about SV and harm reduction given to all patients during clinical encounters. GIFTSS (Giving Information for Trauma Support and Safety) provides (a) patient education and assessment regarding SV; (b) discussion of harm reduction behaviors to reduce risk of SV for self and peers (including bystander intervention); and (c) supported referrals to victim services. Interventions effective in reaching more college-age young adults who either witness or experience SV are needed. College student health centers randomized into the GIFTSS intervention arm will receive training in this brief intervention integrated into routine college health visits. The control sites will receive a brief alcohol intervention. Compared to controls, male and female clients receiving the GIFTSS intervention are expected to have greater recognition of what constitutes SV and alcohol-related sexual risk (primary outcome), recognition of sexual coercion, self-efficacy to obtain sexual consent, self-efficacy to enact harm reduction strategies, intentions to intervene, and knowledge of and self-efficacy to use SV-related services (Aim 1). Among participants who have witnessed peer SV, those receiving GIFTSS will be more likely to report interventions to interrupt peer's harmful behaviors (Aim 2). Clients with SV victimization history who receive GIFTSS are expected to be more likely to disclose SV during their clinic visit, report greater use of SV-related services, and report less recent SV victimization at follow up compared to control clients (Aim 3).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Assault, Alcohol Consumption, Intimate Partner Violence
Keywords
Sexual assault, Alcohol consumption, Intimate partner violence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2295 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will receive the GIFTSS intervention provided by college health center staff and clinicians
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants will receive a brief alcohol use reduction intervention based on NIAAA guidelines provided by college health center staff and clinicians
Intervention Type
Behavioral
Intervention Name(s)
GIFTSS
Other Intervention Name(s)
Giving Information for Trauma Support and Safety
Intervention Description
Universal education and brief counseling regarding sexual violence
Intervention Type
Behavioral
Intervention Name(s)
Brief alcohol use intervention
Intervention Description
Brief education and counseling intervention to promote safer alcohol use, reduce binge drinking
Primary Outcome Measure Information:
Title
Change in recognition of alcohol-related sexual violence and sexual risk from baseline to follow up
Description
Changes in overall mean knowledge score measuring recognition of what constitutes sexual violence and the role of alcohol in risk for sexual violence comparing baseline and follow up
Time Frame
4 months and 12 months
Secondary Outcome Measure Information:
Title
Change in self-efficacy to use harm reduction strategies
Description
Post-intervention levels of self-efficacy to use specified harm reduction strategies to reduce risk for sexual violence adjusting for baseline general self-efficacy
Time Frame
4 months and 12 months
Title
Change in knowledge of sexual violence related services from baseline to follow up
Description
Knowing about specified sexual violence related services comparing baseline and follow up summary scores
Time Frame
4 months and 12 months
Title
Change in self-efficacy to use sexual violence related services
Description
Changes in mean score measuring self-efficacy to use violence related services comparing baseline and follow up
Time Frame
4 months and 12 months
Title
Change in intentions to intervene from baseline to follow up
Description
Proclivity to intervene when witnessing disrespectful and harmful behaviors among peers comparing baseline and follow up mean scores on a scale assessing likelihood of trying to stop harmful behaviors among peers
Time Frame
4 months and 12 months
Title
Change in positive bystander behaviors from baseline to follow up
Description
Assessment of recent positive bystander behavior in students when witnessing disrespectful and harmful behaviors among peers comparing baseline and follow up summary scores. Students report if they have witnessed peers' abusive behaviors in recent months and if witnessed, how they responded (whether they intervened to interrupt the behavior)
Time Frame
4 months and 12 months
Title
Change in recognition of sexual coercion from baseline to follow up
Description
Changes in mean score measuring recognition of what constitutes sexual coercion comparing baseline and follow up
Time Frame
4 months and 12 months
Title
Change in self-efficacy to obtain sexual consent
Description
Changes in mean score assessing self-efficacy to obtain sexual consent comparing baseline and follow up
Time Frame
4 months and 12 months
Other Pre-specified Outcome Measures:
Title
Change in sexual violence victimization from baseline to follow up
Description
Among those reporting exposure to sexual violence at baseline, summary score of any sexual violence victimization (including partner violence, forced alcohol consumption prior to sex, respondent alcohol consumption prior to sex, unwanted sexual experiences), comparing the time before the intervention to after the intervention
Time Frame
4 months and 12 months
Title
Sexual violence disclosure to health center provider
Description
Among those reporting exposure to sexual violence, disclosed to health center provider during health center visits
Time Frame
At time of baseline clinical encounter, 4 months, and 12 months
Title
Change in use of sexual violence related services
Description
Any use of sexual violence related services (summary score)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ages 18-24
Able to read English
Seeking care at the college health center for any reason
Exclusion Criteria:
Younger than 18 or older than 24 years
Not seeking care at the college health center
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32362510
Citation
Miller E, Jones KA, McCauley HL, Rofey DL, Clark DB, Talis JM, Anderson JC, Chugani CD, Coulter RWS, Abebe KZ. Cluster Randomized Trial of a College Health Center Sexual Violence Intervention. Am J Prev Med. 2020 Jul;59(1):98-108. doi: 10.1016/j.amepre.2020.02.007. Epub 2020 Apr 30.
Results Reference
derived
PubMed Identifier
29287667
Citation
Abebe KZ, Jones KA, Rofey D, McCauley HL, Clark DB, Dick R, Gmelin T, Talis J, Anderson J, Chugani C, Algarroba G, Antonio A, Bee C, Edwards C, Lethihet N, Macak J, Paley J, Torres I, Van Dusen C, Miller E. A cluster-randomized trial of a college health center-based alcohol and sexual violence intervention (GIFTSS): Design, rationale, and baseline sample. Contemp Clin Trials. 2018 Feb;65:130-143. doi: 10.1016/j.cct.2017.12.008. Epub 2017 Dec 26.
Results Reference
derived
Learn more about this trial
College Health Center-based Alcohol and Sexual Violence Intervention
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