Sexual AssaultGIFTSSNCT02355470
College Health Center-based Alcohol and Sexual Violence Intervention
A study testing GIFTSS and Brief alcohol use intervention in people with Sexual Assault and Alcohol Consumption, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Assault, Alcohol Consumption, Intimate Partner Violence
- What is being tested?
- GIFTSS and Brief alcohol use intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,295 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 27 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-24
- Able to read English
- Seeking care at the college health center for any reason
Who cannot join
- Younger than 18 or older than 24 years
- Not seeking care at the college health center
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: GIFTSS (Giving Information for Trauma Support and Safety): A College Health Center-based Alcohol and Sexual Violence Intervention
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.
Read the 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).
- Being tested
- GIFTSS, Brief alcohol use intervention
- Keywords
- Sexual assault, Alcohol consumption, Intimate partner violence
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIFTSSBehavioural
Also called Giving Information for Trauma Support and Safety
Universal education and brief counseling regarding sexual violence
Brief alcohol use interventionBehavioural
Brief education and counseling intervention to promote safer alcohol use, reduce binge drinking
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive the GIFTSS intervention provided by college health center staff and clinicians Receives: 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 Receives: Behavioral: Brief alcohol use intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months and 12 months
Secondary outcomes (7)
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
Measured: 4 months and 12 months
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
Measured: 4 months and 12 months
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
Measured: 4 months and 12 months
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
Measured: 4 months and 12 months
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)
Measured: 4 months and 12 months
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
Measured: 4 months and 12 months
Change in self-efficacy to obtain sexual consent
Changes in mean score assessing self-efficacy to obtain sexual consent comparing baseline and follow up
Measured: 4 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startAug 2015
- Primary completion27 Apr 2018
- Study completion27 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sexual AssaultStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,295 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Miller, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355470
- Sponsor's protocol ID
- 14110392
- Acronym
- GIFTSS
- Status last verified
- Apr 2018
- First submitted
- 30 Jan 2015
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38761368Anderson 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.
PubMed 37525258Miller 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.
PubMed 32362510Abebe 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.
PubMed 29287667
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GIFTSS (Giving Information for Trauma Support and Safety): A College Health Center-based Alcohol and Sexual Violence Intervention
- ClinicalTrials.gov ID
- NCT02355470
- Acronym / sponsor ID
- GIFTSS / 14110392
- Keywords
- Sexual assault, Alcohol consumption, Intimate partner violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,295 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: GIFTSSParticipants will receive the GIFTSS intervention provided by college health center staff and clinicians |
| Control | Active comparator | Behavioral: Brief alcohol use interventionParticipants will receive a brief alcohol use reduction intervention based on NIAAA guidelines provided by college health center staff and clinicians |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages 18-24
- Able to read English
- Seeking care at the college health center for any reason
Key exclusion criteria (2 listed)
- Younger than 18 or older than 24 years
- Not seeking care at the college health center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIFTSSAlso: Giving Information for Trauma Support and SafetyUniversal education and brief counseling regarding sexual violence | Behavioural | Intervention |
| Brief alcohol use interventionBrief education and counseling intervention to promote safer alcohol use, reduce binge drinking | Behavioural | Control |
Primary outcome
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
7 secondary outcomes
Change in self-efficacy to use harm reduction strategies
Time frame: 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
Change in self-efficacy to use sexual violence related services
Time frame: 4 months and 12 months
Change in intentions to intervene from baseline to follow up
Time frame: 4 months and 12 months
Change in positive bystander behaviors from baseline to follow up
Time frame: 4 months and 12 months
Change in recognition of sexual coercion from baseline to follow up
Time frame: 4 months and 12 months
Change in self-efficacy to obtain sexual consent
Time frame: 4 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Derived from this study: PubMed 38761368Coulter 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.
- Derived from this study: PubMed 37525258Anderson 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.
- Derived from this study: PubMed 32362510Miller 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.
- Derived from this study: PubMed 29287667Abebe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIFTSS and Brief alcohol use intervention in people with Sexual Assault and Alcohol Consumption, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in recognition of alcohol-related sexual violence and sexual risk from baseline to follow up (time frame: 4 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02355470, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.