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A cluster-randomized trial of a college health center-based alcohol and sexual violence intervention (GIFTSS): Design, rationale, and baseline sample.

ABSTRACT: INTRODUCTION:Sexual violence (SV) on college campuses is common, especially alcohol-related SV. This is a 2-arm cluster randomized controlled trial to test a brief intervention to reduce risk for alcohol-related sexual violence (SV) among students receiving care from college health centers (CHCs). Intervention CHC staff are trained to deliver universal SV education to all students seeking care, to facilitate patient and provider comfort in discussing SV and related abusive experiences (including the role of alcohol). Control sites provide participants with information about drinking responsibly. METHODS:Across 28 participating campuses (12 randomized to intervention and 16 to control), 2292 students seeking care at CHCs complete surveys prior to their appointment (baseline), immediately after (exit), 4months later (T2) and one year later (T3). The primary outcome is change in recognition of SV and sexual risk. Among those reporting SV exposure at baseline, changes in SV victimization, disclosure, and use of SV services are additional outcomes. Intervention effects will be assessed using generalized linear mixed models that account for clustering of repeated observations both within CHCs and within students. RESULTS:Slightly more than half of the participating colleges have undergraduate enrollment of ?3000 students; two-thirds are public and almost half are urban. Among participants there were relatively more Asian (10 v 1%) and Black/African American (13 v 7%) and fewer White (58 v 74%) participants in the intervention compared to control. CONCLUSIONS:This study will offer the first formal assessment for SV prevention in the CHC setting. Clinical Trials #: NCT02355470.

SUBMITTER: Abebe KZ

PROVIDER: S-EPMC5803349 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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A cluster-randomized trial of a college health center-based alcohol and sexual violence intervention (GIFTSS): Design, rationale, and baseline sample.

Abebe Kaleab Z KZ Jones Kelley A KA Rofey Dana D McCauley Heather L HL Clark Duncan B DB Dick Rebecca R Gmelin Theresa T Talis Janine J Anderson Jocelyn J Chugani Carla C Algarroba Gabriela G Antonio Ashley A Bee Courtney C Edwards Clare C Lethihet Nadia N Macak Justin J Paley Joshua J Torres Irving I Van Dusen Courtney C Miller Elizabeth E

Contemporary clinical trials 20171226

<h4>Introduction</h4>Sexual violence (SV) on college campuses is common, especially alcohol-related SV. This is a 2-arm cluster randomized controlled trial to test a brief intervention to reduce risk for alcohol-related sexual violence (SV) among students receiving care from college health centers (CHCs). Intervention CHC staff are trained to deliver universal SV education to all students seeking care, to facilitate patient and provider comfort in discussing SV and related abusive experiences (i ...[more]

PMID: 29287667

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Project description:IntroductionSexual violence, particularly in the context of drinking, is prevalent on college campuses. This study tested a brief intervention to prevent sexual violence among students receiving care from college health centers.Study designThis study was a two-arm, unblinded cluster RCT.Setting/participantsOn 28 campuses with health/counseling centers (1:1 randomization allocation; 12 intervention and 16 control), from September 2015 to March 2018, a total of 2,291 students seeking care at college health centers completed surveys before the appointment, immediately after, 4 months later, and 12 months later.InterventionIntervention college health center staff received training on delivering sexual violence education to all students seeking care. Control sites provided information about drinking responsibly.Main outcome measuresThe primary outcome was students' change in recognition of sexual violence. Additional outcomes included sexual violence disclosure and use of services among students with a history of sexual violence at baseline. Generalized linear mixed models accounting for campus-level clustering assessed intervention effects. Data were analyzed from September 2018 to June 2019.ResultsHalf (55%) of students seeking care at college health centers reported any history of sexual violence exposure. No between-group differences in primary (β=0.001, 95% CI= -0.04, 0.04) or secondary outcomes emerged between intervention and control students. Post-hoc analyses adjusting for the intensity of intervention delivery (intensity-adjusted) revealed an increase in self-efficacy to use harm reduction strategies (β=0.09, 95% CI=0.01, 0.18) among intervention participants. Among those who reported sexual violence at baseline, intervention students had increased odds of disclosing violence during the visit (AOR=4.47, 95% CI=2.25, 8.89) in intensity-adjusted analyses compared with control. No between-group differences emerged for remaining outcomes.ConclusionsSexual violence exposure is high among students seeking care in college health centers. A brief provider-delivered sexual violence intervention, when implemented with fidelity, was associated with improved self-efficacy to use harm reduction and increased disclosure of sexual violence during clinical encounters but no increased use of services. More interventions that are stronger in intensity are needed to connect students to sexual violence services.Trial registrationThis study is registered at www.clinicaltrials.gov NCT02355470.

Project description:BackgroundSexual violence (SV) incidence among college women has been invariant for the past 20 years. Innovative prevention strategies that are low resource and technology driven but demonstrate efficacy are greatly needed.ObjectiveThe aim of this study was to determine the efficacy of a novel theoretically driven internet-based intervention for first-year college students who identify as women (RealConsent) in reducing their risk of exposure to SV and alcohol misuse as well as increasing alcohol protective and bystander behaviors.MethodsThis randomized controlled trial involved first-year college students who identified as women (n=881) attending 1 of 3 universities in the southeastern United States. Participants aged 18 to 20 years were randomized to RealConsent (444/881, 50.4%) or to an attention-matched placebo control (437/881, 49.6%). RealConsent is fully automated and consists of four 45-minute modules that incorporate entertainment-education media and proven behavior change techniques. The primary outcome was exposure to SV; the secondary outcomes were alcohol protective behaviors, dating risk behaviors, alcohol misuse, and bystander behavior. Study outcomes were assessed at baseline and 6-month follow-up.ResultsAmong participants with some exposure to SV, those in the RealConsent group experienced less exposure to SV than the placebo group (adjusted incidence rate ratio 0.48, 95% CI 0.33-0.69; P=.002). Furthermore, participants in the RealConsent group engaged in more alcohol protective behaviors (adjusted odds ratio 1.17, 95% CI 0.12-2.22; P=.03) and were less likely to binge drink (adjusted incidence rate ratio 0.81, 95% CI 0.67-0.97; P=.003). Finally, participants in the RealConsent group who had 100% dosage were more likely to engage in bystander behavior than those with <100% dosage plus placebo group (adjusted odds ratio 1.72, 95% CI 1.17-2.55; P=.006).ConclusionsA comprehensive exposure to SV, alcohol use, and bystander educational program was successful in decreasing the occurrence of exposure to SV among those most at risk and in increasing alcohol protective behaviors. Because of its web-based and mobile technologies, RealConsent can be easily disseminated and holds potential for reducing campus SV.Trial registrationClinicalTrials.gov NCT03726437; https://clinicaltrials.gov/ct2/show/NCT03726437.

Project description:BackgroundBystander intervention approaches offer promise for reducing rates of sexual violence on college campuses. Most interventions are in-person small-group formats, which limit their reach and reduce their overall public health impact.ObjectiveThis study evaluated the efficacy of RealConsent, a Web-based bystander approach to sexual violence prevention, in enhancing prosocial intervening behaviors and preventing sexual violence perpetration.MethodsA random probability sample of 743 male undergraduate students (aged 18 to 24 years) attending a large, urban university located in the southeastern United States was recruited online and randomized to either RealConsent (n=376) or a Web-based general health promotion program (n=367). Participants were surveyed online at baseline, postintervention, and 6-months postintervention. RealConsent was delivered via a password-protected Web portal that contained six 30-minute media-based and interactive modules covering knowledge of informed consent, communication skills regarding sex, the role of alcohol and male socialization in sexual violence, empathy for rape victims, and bystander education. Primary outcomes were self-reported prosocial intervening behaviors and sexual violence perpetration. Secondary outcomes were theoretical mediators (eg, knowledge, attitudes).ResultsAt 6-month follow-up RealConsent participants intervened more often (P=.04) and engaged in less sexual violence perpetration (P=.04) compared to controls. In addition, RealConsent participants reported greater legal knowledge of sexual assault (P<.001), greater knowledge of effective consent (P<.001), less rape myths (P<.001), greater empathy for rape victims (P<.001), less negative date rape attitudes (P<.001), less hostility toward women (P=.01), greater intentions to intervene (P=.04), less hyper-gender ideology (P<.001), less positive outcome expectancies for nonconsensual sex (P=.03), more positive outcome expectancies for intervening (P<.001), and less comfort with other men's inappropriate behaviors (P<.001).ConclusionsOur results support the efficacy of RealConsent. Due to its Web-based format, RealConsent has potential for broad-based dissemination thereby increasing its overall public health impact on sexual violence.Trial registrationClinicaltrials.gov: NCT01903876; http://clinicaltrials.gov/show/NCT01903876 (Archived by WebCite at http://www.webcitation.org/6S1PXxWKt).

Project description:BackgroundSexual violence-any sexual act committed against a person without freely given consent-disproportionately affects women. Women's first experiences of sexual violence often occur in adolescence. In Asia and the Pacific, 14% of sexually experienced adolescent girls report forced sexual debut. Early prevention with men that integrates a bystander framework is one way to address attitudes and behavior while reducing potential resistance to participation.MethodsThis paper describes a study protocol to adapt RealConsent for use in Vietnam and to test the impact of the adapted program-GlobalConsent-on cognitive/attitudinal/affective mediators, and in turn, on sexual violence perpetration and prosocial bystander behavior. RealConsent is a six-session, web-based educational entertainment program designed to prevent sexual violence perpetration and to enhance prosocial bystander behavior in young men. The program has reduced the incidence of sexual violence among men attending an urban, public university in the Southeastern United States. We used formative qualitative research and the Centers for Disease Control and Prevention's Map of the Adaptation Process to adapt RealConsent. We conducted semi-structured interviews with college men (n = 12) and women (n = 9) to understand the social context of sexual violence. We conducted focus group discussions with university men and stakeholders (n = 14) to elicit feedback on the original program. From these data, we created scripts in storyboard format of the adapted program. We worked closely with a small group of university men to elicit feedback on the storyboards and to refine them for acceptability and production. We are testing the final program-GlobalConsent-in a randomized controlled trial in heterosexual or bisexual freshmen men 18-24 years attending two universities in Hanoi. We are testing the impact of GlobalConsent (n = 400 planned), relative to a health-education attention control condition we developed (n = 400 planned), on cognitive/attitudinal/affective mediators, prosocial bystander behavior, and sexual violence perpetration.DiscussionThis project is the first to test the impact of an adapted, theoretically grounded, web-based educational entertainment program to prevent sexual violence perpetration and to promote prosocial bystander behavior among young men in a middle-income country. If effective, GlobalConsent will have exceptional potential to prevent men's sexual violence against women globally.Trial registrationU.S. National Library of Medicine Clinicaltrials.gov NCT04147455 on November 1, 2019 (Version 1). Retrospectively registered. Protocol amendments will be submitted to clinicaltrials.gov .

Project description:BackgroundUsing the multiphase optimization strategy (MOST), we previously developed and optimized an online behavioral intervention, itMatters, aimed at reducing the risk of sexually transmitted infections (STI) among first-year college students by targeting the intersection of alcohol use and sexual behaviors.PurposeWe had two goals: (a) to evaluate the optimized itMatters intervention and (b) to determine whether the candidate sexual violence prevention (SVP) component (included at the request of participating universities) had a detectable effect and therefore should be added to create a new version of itMatters. We also describe the hybrid evaluation-optimization trial we conducted to accomplish these two goals in a single experiment.MethodsFirst year college students (N = 3,098) at four universities in the USA were individually randomized in a hybrid evaluation-optimization 2 × 2 factorial trial. Data were analyzed using regression models, with pre-test outcome variables included as covariates in the models. Analyses were conducted separately with (a) immediate post-test scores and (b) 60-day follow-up scores as outcome variables.ResultsExperimental results indicated a significant effect of itMatters on targeted proximal outcomes (norms) and on one distal behavioral outcome (binge drinking). There were no significant effects on other behavioral outcomes, including the intersection of alcohol and sexual behaviors. In addition, there were mixed results (positive short-term effect; no effect at 60-day follow-up) of the SVP component on targeted proximal outcomes (students' self-efficacy to reduce/prevent sexual violence and perceived effectiveness of protective behavioral strategies).ConclusionsThe hybrid evaluation-optimization trial enabled us to evaluate the individual and combined effectiveness of the optimized itMatters intervention and the SVP component in a single experiment, conserving resources and providing greatly improved efficiency.Trial registrationNCT04095065.

Dataset Information

A cluster-randomized trial of a college health center-based alcohol and sexual violence intervention (GIFTSS): Design, rationale, and baseline sample.

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A cluster-randomized trial of a college health center-based alcohol and sexual violence intervention (GIFTSS): Design, rationale, and baseline sample.

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