Interactive Digital Intervention to Prevent Violence Among Young Adults
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03820609 |
Recruitment Status :
Completed
First Posted : January 29, 2019
Last Update Posted : April 3, 2019
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Condition or disease | Intervention/treatment | Phase |
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Sexual Assault | Behavioral: Digital Intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 41 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | A non-randomized open trial with a 1-month follow up will assess preliminary effects on attitudes and behaviors, and will establish procedures for assessing change in proximal (attitude) and distal (behavioral) outcomes in preparation for large-scale evaluation in a Phase 2 SBIR proposal. |
Masking: | None (Open Label) |
Masking Description: | The outcome evaluation is a non-randomized open pilot trial. Therefore, all participants and project collaborators are aware that individuals enrolled in the study are asked to complete the prevention program. |
Primary Purpose: | Prevention |
Official Title: | Interactive Digital Intervention to Prevent Violence Among Young Adults |
Actual Study Start Date : | June 5, 2018 |
Actual Primary Completion Date : | July 15, 2018 |
Actual Study Completion Date : | August 15, 2018 |
Arm | Intervention/treatment |
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Experimental: Digital Intervention
Make a Change is a universal sexual assault (SA) prevention program that aligns with best-practices in prevention, utilizes the theory and strategies of serious games for health, and addresses risk and protective factors for SA across the social ecology of individual, peer and community factors that foster SA. This novel digital application also leverages theories of behavior change within serious games for health, and integrates successful practices in videogame design to promote engagement, learning and skill-building.
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Behavioral: Digital Intervention
This digital application for sexual assault prevention can be completed on a tablet computer. |
- Sexual aggression [ Time Frame: 1-month follow-up ]Assessed via the Sexual Experiences Survey - Revised
- Sexual victimization [ Time Frame: 1-month follow-up ]Assessed via the Sexual Experiences Survey - Revised
- Bystander intervention [ Time Frame: 1-month follow-up ]Assessed via the Bystander Attitudes Survey
- Rape supportive beliefs [ Time Frame: 1-month follow-up ]Assessed via the Short-Form Illinois Rape Myth Acceptance Scale
- Perception of peer support for sexual aggression [ Time Frame: 1-month follow-up ]Assess through items from Boeringer's Social Norms Measure and Clemson's Peer Pressure Measure
- Perceived peer norms [ Time Frame: 1-month follow-up ]Change in the accuracy in perception of peer norms (assessed via responses to in-app questions)
- Bystander intervention confidence [ Time Frame: 1-month follow-up ]Assessed via the Bystander Efficacy Scale from ARC-3
- Communication of consent [ Time Frame: 1-month follow-up ]Assessed via the Consent Experiences Scale
- Self-protective behavior [ Time Frame: 1-month follow-up ]Assessed via the Alcohol Use Self-Protective Behavior Scale
- Psychological barriers to resistance [ Time Frame: 1-month follow-up ]Assessed via the Psychological Barriers to Resistance Instrument

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Ages Eligible for Study: | 18 Years to 24 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Between the ages of 18 and 24
- Enrolled as a student at one of the study sites
Exclusion Criteria:
- None

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820609
United States, Rhode Island | |
Community College of Rhode Island | |
Warwick, Rhode Island, United States, 02886 | |
United States, South Carolina | |
Clemson University | |
Clemson, South Carolina, United States, 29634 |
Principal Investigator: | Sharon Wood | Happy People Games |
Responsible Party: | Happy People Games, LLC |
ClinicalTrials.gov Identifier: | NCT03820609 |
Other Study ID Numbers: |
HappyPeopleGames |
First Posted: | January 29, 2019 Key Record Dates |
Last Update Posted: | April 3, 2019 |
Last Verified: | April 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | There is no IPD sharing plan. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Sexual Assault Digital Intervention |