College Health Center-based Alcohol and Sexual Violence Intervention

NCT02355470 | Completed DMC

• 1 other identifier: 14110392
• Study Type: interventional
• Target: 2,295
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Assault; Alcohol Consumption; Intimate Partner Violence

Keywords

Sexual assault; Alcohol consumption; Intimate partner violence

Outcome Measures

Primary Outcomes (1)

• 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

  4 months and 12 months

Secondary Outcomes (7)

• Change in self-efficacy to use harm reduction strategies

  4 months and 12 months

• Change in knowledge of sexual violence related services from baseline to follow up

  4 months and 12 months

• Change in self-efficacy to use sexual violence related services

  4 months and 12 months

• Change in intentions to intervene from baseline to follow up

  4 months and 12 months

• Change in positive bystander behaviors from baseline to follow up

  4 months and 12 months

Other Outcomes (3)

• Change in sexual violence victimization from baseline to follow up

  4 months and 12 months

• Sexual violence disclosure to health center provider

  At time of baseline clinical encounter, 4 months, and 12 months

• Change in use of sexual violence related services

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: GIFTSS

Control

ACTIVE COMPARATOR

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

Behavioral: Brief alcohol use intervention

Interventions

GIFTSS BEHAVIORAL

Universal education and brief counseling regarding sexual violence

Also known as: Giving Information for Trauma Support and Safety

Intervention

Brief alcohol use intervention BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18-24
• Able to read English
• Seeking care at the college health center for any reason

You may not qualify if:

• Younger than 18 or older than 24 years
• Not seeking care at the college health center

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

• 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.

  PMID: 38761368 DERIVED

• 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.

  PMID: 37525258 DERIVED

• 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.

  PMID: 32362510 DERIVED

• 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.

  PMID: 29287667 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Safety; Ethanol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Accident Prevention; Accidents; Public Health; Environment and Public Health; Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: February 4, 2015
• Study Start: August 1, 2015
• Primary Completion: April 27, 2018
• Study Completion: April 27, 2018
• Last Updated: April 30, 2018

Record last verified: 2018-04

Locations

US (1)