NCT07888153

Brief Summary

The National Institute of Health Academic Research Enhancement Award research study fills a major gap in sexual violence and alcohol misuse prevention on college campuses by implementing and testing the feasibility of a multi-level social ecological model approach consisting of six established e-health primary prevention strategies in a feasibility study.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for phase_2

Timeline
24mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Oct 2028

First Submitted

Initial submission to the registry

May 5, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

September 21, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 22, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

October 22, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

May 5, 2026

Last Update Submit

October 15, 2026

Conditions

Keywords

sexual violencesexual assaultalcohol misuseE-Healthbystander

Outcome Measures

Primary Outcomes (4)

  • Sexual Experiences Survey-Short Form Victimization

    Sexual assault victimization was assessed with Revised Sexual Experience Survey. Participants were asked how often they experienced 7 unwanted sexual experiences. Also, the tactic that was used (for example, "using force") was also noted. Response options ranged from 0 (never) to 3 (3 or more times). An overall score for the Revised Sexual Experience Survey, was calculated by Summing each Outcome and Tactic Score with a range from 0 to 135 with higher scores indicating more sexual violence victimization, a worse score than the lower scores. The second method combines several of the outcomes, but keeps tactics separate, resulting in a potential range of 0 to 63 with the higher score being a worse score than the lower score.

    Baseline, 8 weeks, 16 weeks

  • Sexual Experiences Survey-Short Form Perpetration

    The Sexual Experiences Survey-Short Form Perpetration is a 7-item, behaviorally specific self-report instrument designed to assess the perpetration of unwanted sexual behaviors. It covers sexual coercion, unwanted contact, attempted rape, and rape, typically asking about acts committed since age 14 or in the past year. The higher score indicates more unwanted sexual experiences and therefore is a worse score than a lower score.

    Baseline, 8 weeks, 16 weeks

  • Alcohol Use Disorders Identification Test-Concise

    The Alcohol Use Disorders Identification Test is a 10-item screening tool developed by the World Health Organization to assess alcohol consumption, drinking behaviors, and alcohol-related problems. The higher the score indicates more alcohol related problems, therefore a worse score.

    Baseline, 8 weeks, 16 weeks

  • Drinking Behavior Questionnaire

    A ten-item self report measure looking at an individual's drinking habits. The higher the score indicates more problematic drinking habits, therefore a worse score.

    Baseline, 8 weeks, 16 weeks

Secondary Outcomes (7)

  • Bystander Attitudes Scale Revised

    Baseline, 8 weeks, 16 weeks

  • Barriers to Sexual Assault Bystander Intervention Scale

    Baseline, 8 weeks, 16 weeks

  • Social Self-identification Scale

    8 weeks, 16 weeks

  • Bystander Efficacy Scale

    Baseline, 8 weeks, 16 weeks

  • Updated Illinois Rape Myth Acceptance Scale,

    Baseline, 8 weeks, 16 weeks

  • +2 more secondary outcomes

Study Arms (2)

Cross Cutting e-health Prevention Program Individual Programming Intervention

EXPERIMENTAL

Participants in the intervention arm will participate in the RealConsent serial webinar program, the +Change Social Norms Program, and the ShipHappens Bystander Video Game.

Behavioral: Cross Cutting e-health Prevention Program Individual Interventions

Cross Cutting e-health Prevention Program Control Arm

NO INTERVENTION

True control group.

Interventions

Three sexual violence and alcohol misuse ehealth prevention programs for college students.

Also known as: RealConsent, +Change, ShipHappens
Cross Cutting e-health Prevention Program Individual Programming Intervention

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • full-time University of New Hampshire student
  • first-year University of New Hampshire student
  • live in the University of New Hampshire residence halls
  • not married

You may not qualify if:

  • not a University of New Hampshire first-year student
  • does not live in the University of New Hampshire residence halls
  • married

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Hampshire

Durham, New Hampshire, 03824, United States

RECRUITING

Related Publications (20)

  • Potter SJ, Moynihan MM, Stapleton JG. Using social self-identification in social marketing materials aimed at reducing violence against women on campus. J Interpers Violence. 2011 Mar;26(5):971-90. doi: 10.1177/0886260510365870. Epub 2010 Jun 3.

    PMID: 20522887BACKGROUND
  • Salazar LF, Vivolo-Kantor A, Hardin J, Berkowitz A. A web-based sexual violence bystander intervention for male college students: randomized controlled trial. J Med Internet Res. 2014 Sep 5;16(9):e203. doi: 10.2196/jmir.3426.

    PMID: 25198417BACKGROUND
  • Salazar LF, Vivolo-Kantor A, McGroarty-Koon K. Formative Research With College Men to Inform Content and Messages for a Web-Based Sexual Violence Prevention Program. Health Commun. 2017 Sep;32(9):1133-1141. doi: 10.1080/10410236.2016.1214219. Epub 2016 Sep 3.

    PMID: 27593559BACKGROUND
  • Schipani-McLaughlin AM, Gilmore AK, Salazar LF, Potter SJ, Stapleton JG, Orchowski LM. Advancing a Comprehensive Multilevel Approach to Sexual Violence Prevention Using Existing Efficacious Programs. J Forensic Nurs. 2024 Jan-Mar 01;20(1):20-29. doi: 10.1097/JFN.0000000000000457. Epub 2023 Nov 24.

    PMID: 38015061BACKGROUND
  • Basile KC, DeGue S, Jones K, et al. STOP SV: A Technical Package to Prevent Sexual Violence. National Center for Injury Prevention and Control, Centers for Disease Control and Prevension. Published online 2016.

    BACKGROUND
  • Potter S, Howard R, Murphy S, Moynihan MM. Long-term impacts of college sexual assaults on women survivors' educational and career attainments. J Am Coll Health. 2018 Aug-Sep;66(6):496-507. doi: 10.1080/07448481.2018.1440574. Epub 2018 Mar 30.

    PMID: 29447618BACKGROUND
  • doi:10.1177/1521025115584750

    BACKGROUND
  • doi:10.1037/a0033470

    BACKGROUND
  • Crosby RA, Salazar LF. Essentials of Public Health Research Methods. 1st ed. Jones & Bartlett Learning; 2021. Accessed October 11, 2023. https://www.jblearning.com/catalog

    BACKGROUND
  • Moynihan MM, Banyard VL, Cares AC, Potter SJ, Williams LM, Stapleton JG. Encouraging responses in sexual and relationship violence prevention: what program effects remain 1 year later? J Interpers Violence. 2015 Jan;30(1):110-32. doi: 10.1177/0886260514532719. Epub 2014 May 20.

    PMID: 24850763BACKGROUND
  • Potter SJ, Stapleton JG. Bringing in the target audience in bystander social marketing materials for communities: suggestions for practitioners. Violence Against Women. 2011 Jun;17(6):797-812. doi: 10.1177/1077801211410364.

    PMID: 21727157BACKGROUND
  • Potter SJ, Flanagan M, Seidman M, Hodges H, Stapleton JG. Developing and Piloting Videogames to Increase College and University Students' Awareness and Efficacy of the Bystander Role in Incidents of Sexual Violence. Games Health J. 2019 Feb;8(1):24-34. doi: 10.1089/g4h.2017.0172. Epub 2018 Sep 5.

    PMID: 30183345BACKGROUND
  • Gilmore AK, Lewis MA, George WH. A randomized controlled trial targeting alcohol use and sexual assault risk among college women at high risk for victimization. Behav Res Ther. 2015 Nov;74:38-49. doi: 10.1016/j.brat.2015.08.007. Epub 2015 Aug 29.

    PMID: 26408290BACKGROUND
  • Gilmore AK, Leone RM, Oesterle DW, Davis KC, Orchowski LM, Ramakrishnan V, Kaysen D. Web-Based Alcohol and Sexual Assault Prevention Program With Tailored Content Based on Gender and Sexual Orientation: Preliminary Outcomes and Usability Study of Positive Change (+Change). JMIR Form Res. 2022 Jul 22;6(7):e23823. doi: 10.2196/23823.

    PMID: 35867393BACKGROUND
  • Salazar LF, Schipani-McLaughlin AM, Sebeh Y, Nizam Z, Hayat M. A Web-Based Sexual Violence, Alcohol Misuse, and Bystander Intervention Program for College Women (RealConsent): Randomized Controlled Trial. J Med Internet Res. 2023 Jun 21;25:e43740. doi: 10.2196/43740.

    PMID: 37342080BACKGROUND
  • Schipani-McLaughlin AM, Salazar LF, Muilenburg JL, Lauckner C, Swartzendruber A, Walters D. A Mixed Media Campaign to Promote Bystander Intervention and Reduce Alcohol Use Among College Students: A Pilot Study. Health Promot Pract. 2022 Nov;23(6):973-983. doi: 10.1177/15248399211027542. Epub 2021 Jul 31.

    PMID: 34338037BACKGROUND
  • Potter SJ, Moschella EA, Smith D, Draper N. Exploring the Usage of a Violence Prevention and Response App Among Community College Students. Health Educ Behav. 2020 Jun;47(1_suppl):44S-53S. doi: 10.1177/1090198120910995.

    PMID: 32452252BACKGROUND
  • 10.1080/15228835.2021.1929665

    BACKGROUND
  • Salazar LF, Vivolo-Kantor A, Schipani-McLaughlin AM. Theoretical Mediators of RealConsent: A Web-Based Sexual Violence Prevention and Bystander Education Program. Health Educ Behav. 2019 Feb;46(1):79-88. doi: 10.1177/1090198118779126. Epub 2018 Jul 11.

    PMID: 29996689BACKGROUND
  • Potter SJ. Using a multimedia social marketing campaign to increase active bystanders on the college campus. J Am Coll Health. 2012;60(4):282-95. doi: 10.1080/07448481.2011.599350.

    PMID: 22559087BACKGROUND

Central Study Contacts

Sharyn J Potter, PhD, MPH

CONTACT

Jane G Stapleton, MS

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2026

First Posted

October 22, 2026

Study Start

September 21, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

October 1, 2028

Last Updated

October 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

The research team will retain and share aggregated quantitative and qualitative data (after all identifying information is redacted), if users commit to the following: (1) using the data only for research purposes and not to identify any individual participant; (2) securing the data using appropriate computer technology (for example, using a secure firewall-protected server to store datasets and transcriptions); and (3) destroying or returning the data after analyses are completed. If the researcher agrees to these stipulations, the PI will send him/her the data set prepared using Statistical Package for Social Sciences 29 and/or the de-identified transcriptions from focus groups. Research participants will be identified by number. All data, including focus group transcriptions, will not include identifying information from any participant. Any information that could potentially identify a participant will be removed from the data set.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The scientific data will be made available to other users no later than time of an associated publication or end of the performance period, whichever comes first and for how long data will be available.
Access Criteria
Upon completion of the proposed study, we will work with the program officer to access how to share the data and will follow their direction.

Locations