College Health Center-based Alcohol and Sexual Violence Intervention (GIFTSS)
GIFTSS (Giving Information for Trauma Support and Safety): A College Health Center-based Alcohol and Sexual Violence Intervention
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Intervention
Participants will receive the GIFTSS intervention provided by college health center staff and clinicians
|
Universal education and brief counseling regarding sexual violence
Other Names:
|
|
Active Comparator: Control
Participants will receive a brief alcohol use reduction intervention based on NIAAA guidelines provided by college health center staff and clinicians
|
Brief education and counseling intervention to promote safer alcohol use, reduce binge drinking
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in recognition of alcohol-related sexual violence and sexual risk from baseline to follow up
Time Frame: 4 months and 12 months
|
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
|
4 months and 12 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in self-efficacy to use harm reduction strategies
Time Frame: 4 months and 12 months
|
Post-intervention levels of self-efficacy to use specified harm reduction strategies to reduce risk for sexual violence adjusting for baseline general self-efficacy
|
4 months and 12 months
|
|
Change in knowledge of sexual violence related services from baseline to follow up
Time Frame: 4 months and 12 months
|
Knowing about specified sexual violence related services comparing baseline and follow up summary scores
|
4 months and 12 months
|
|
Change in self-efficacy to use sexual violence related services
Time Frame: 4 months and 12 months
|
Changes in mean score measuring self-efficacy to use violence related services comparing baseline and follow up
|
4 months and 12 months
|
|
Change in intentions to intervene from baseline to follow up
Time Frame: 4 months and 12 months
|
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
|
4 months and 12 months
|
|
Change in positive bystander behaviors from baseline to follow up
Time Frame: 4 months and 12 months
|
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)
|
4 months and 12 months
|
|
Change in recognition of sexual coercion from baseline to follow up
Time Frame: 4 months and 12 months
|
Changes in mean score measuring recognition of what constitutes sexual coercion comparing baseline and follow up
|
4 months and 12 months
|
|
Change in self-efficacy to obtain sexual consent
Time Frame: 4 months and 12 months
|
Changes in mean score assessing self-efficacy to obtain sexual consent comparing baseline and follow up
|
4 months and 12 months
|
Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in sexual violence victimization from baseline to follow up
Time Frame: 4 months and 12 months
|
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
|
4 months and 12 months
|
|
Sexual violence disclosure to health center provider
Time Frame: At time of baseline clinical encounter, 4 months, and 12 months
|
Among those reporting exposure to sexual violence, disclosed to health center provider during health center visits
|
At time of baseline clinical encounter, 4 months, and 12 months
|
|
Change in use of sexual violence related services
Time Frame: 12 months
|
Any use of sexual violence related services (summary score)
|
12 months
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 14110392
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.