College Health Center-based Alcohol and Sexual Violence Intervention

NCT ID: NCT02355470

Last Updated: 2018-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2295 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-04-27

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).

Conditions

Sexual Assault; Alcohol Consumption; Intimate Partner Violence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

Participants will receive the GIFTSS intervention provided by college health center staff and clinicians

Group Type: EXPERIMENTAL

GIFTSS

Intervention Type: BEHAVIORAL

Universal education and brief counseling regarding sexual violence

Control

Participants will receive a brief alcohol use reduction intervention based on NIAAA guidelines provided by college health center staff and clinicians

Group Type: ACTIVE_COMPARATOR

Brief alcohol use intervention

Intervention Type: BEHAVIORAL

Brief education and counseling intervention to promote safer alcohol use, reduce binge drinking

Interventions

GIFTSS

Universal education and brief counseling regarding sexual violence

Intervention Type: BEHAVIORAL

Brief alcohol use intervention

Brief education and counseling intervention to promote safer alcohol use, reduce binge drinking

Intervention Type: BEHAVIORAL

Other Intervention Names

Giving Information for Trauma Support and Safety

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Miller

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Coulter RWS, Gartner RE, Cramer C, Smith EK, Abebe KZ, Miller E. Universal Sexual Violence Intervention Effects in a Cluster-Randomized Trial: Moderation by Sexual Orientation. J Interpers Violence. 2025 Feb;40(3-4):582-606. doi: 10.1177/08862605241253031. Epub 2024 May 18.

Reference Type: DERIVED

PMID: 38761368 (View on PubMed)

Anderson JC, Peruggia G, Miller-Walfish S, Talis J, Burrell C, Hayes M, Miller E. A case series measuring campus and clinic level factors during implementation of a sexual violence prevention intervention in campus health and counseling centers: does environment matter? Implement Sci Commun. 2023 Jul 31;4(1):88. doi: 10.1186/s43058-023-00467-7.

Reference Type: DERIVED

PMID: 37525258 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32362510 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29287667 (View on PubMed)

Other Identifiers

14110392

Identifier Type: -

Identifier Source: org_study_id