Clinical trial NCT02355470: College Health Center-based Alcohol and Sexual Violence Intervention
Official title: GIFTSS (Giving Information for Trauma Support and Safety): A College Health Center-based Alcohol and Sexual Violence Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Assault
Alcohol Consumption
Intimate Partner Violence
Keywords: Sexual assault
Alcohol consumption
Intimate partner violence
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 2295
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Change in recognition of alcohol-related sexual violence and sexual risk from baseline to follow up
timeFrame: 4 months and 12 months
Secondary outcomes:
measure: Change in self-efficacy to use harm reduction strategies
timeFrame: 4 months and 12 months
measure: Change in knowledge of sexual violence related services from baseline to follow up
timeFrame: 4 months and 12 months
measure: Change in self-efficacy to use sexual violence related services
timeFrame: 4 months and 12 months
measure: Change in intentions to intervene from baseline to follow up
timeFrame: 4 months and 12 months
measure: Change in positive bystander behaviors from baseline to follow up
timeFrame: 4 months and 12 months
measure: Change in recognition of sexual coercion from baseline to follow up
timeFrame: 4 months and 12 months
measure: Change in self-efficacy to obtain sexual consent
timeFrame: 4 months and 12 months
Other outcomes:
measure: Change in sexual violence victimization from baseline to follow up
timeFrame: 4 months and 12 months
measure: Sexual violence disclosure to health center provider
timeFrame: At time of baseline clinical encounter, 4 months, and 12 months
measure: Change in use of sexual violence related services
timeFrame: 12 months
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References:
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.
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.