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Interactive Digital Intervention to Prevent Violence Among Young Adults

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ClinicalTrials.gov Identifier: NCT03820609
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : April 3, 2019
Sponsor:
Collaborator:
Clemson University
Information provided by (Responsible Party):
Happy People Games, LLC

Study Description
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Brief Summary:
The primary aim of this Phase I SBIR is to create and test an alpha version of Make a Change for mobile devices, and to document the technical merit, commercial viability, and proof of concept of the product. Successful completion of this proposal will result in the creation of two assets: 1) an "Intervention Manual" that (similar to a logic model) will align key game mechanics with theory and behavior change goals and, 2) the digital application for mobile devices. Focus groups and interviews with students, as well as interviews with campus stakeholders, will be used to inform development of the digital application and ensure its commercial viability. 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. This line of research and development has the potential to develop a commercially viable product with high public health impact that can be disseminated to 1700+ community colleges and 3,000+ 4-year colleges, and readily adapted to high schools, clinics and military settings.

Condition or disease Intervention/treatment Phase
Sexual Assault Behavioral: Digital Intervention Not Applicable

Detailed Description:
Sexual assault (SA) is prevalent among students at 2- and 4-year colleges. The rate of SA among college students is three times greater than the rate in the general population, making prevention on college campuses a public health priority. There are no college SA prevention programs that document reductions in SA in a rigorous research design. Digital applications that use the theory and strategies of serious games integrate proven theories of behavior change (social cognitive theory, self-determination theory) to produce sustained, measurable behavioral outcomes, and are effective for promoting change in a range of health behaviors. Digital applications have high market potential in light of widespread use of mobile devices among young adults. Problematically, there are no commercially-available digital applications for SA prevention with efficacy in reducing SA. Accordingly, in this proposal, the Interactive Digital Intervention to Prevent Violence among Young Adults team will design, create and pilot the Make a Change digital application. Make a Change is a universal 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. This team consists of experts in SA prevention, commercial videogame production, the development and testing of serious games for health, and business development and marketing. The primary aim of this Phase I SBIR is to create and test an alpha version of Make a Change for mobile devices, and to document the technical merit, commercial viability, and proof of concept of the product. Successful completion of this proposal will result in the creation of two assets: 1) an "Intervention Manual" that (similar to a logic model) will align key game mechanics with theory and behavior change goals and, 2) the digital application for mobile devices. Focus groups and interviews with students, as well as interviews with campus stakeholders, will be used to inform development of the digital application and ensure its commercial viability. 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. This line of research and development has the potential to develop a commercially viable product with high public health impact that can be disseminated to 1700+ community colleges and 3,000+ 4-year colleges, and readily adapted to high schools, clinics and military settings.
Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
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.
 Behavioral: Digital Intervention
This digital application for sexual assault prevention can be completed on a tablet computer.


Outcome Measures
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Primary Outcome Measures :
  1. Sexual aggression [ Time Frame: 1-month follow-up ]
    Assessed via the Sexual Experiences Survey - Revised

  2. Sexual victimization [ Time Frame: 1-month follow-up ]
    Assessed via the Sexual Experiences Survey - Revised

  3. Bystander intervention [ Time Frame: 1-month follow-up ]
    Assessed via the Bystander Attitudes Survey


Secondary Outcome Measures :
  1. Rape supportive beliefs [ Time Frame: 1-month follow-up ]
    Assessed via the Short-Form Illinois Rape Myth Acceptance Scale

  2. 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

  3. 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)

  4. Bystander intervention confidence [ Time Frame: 1-month follow-up ]
    Assessed via the Bystander Efficacy Scale from ARC-3

  5. Communication of consent [ Time Frame: 1-month follow-up ]
    Assessed via the Consent Experiences Scale

  6. Self-protective behavior [ Time Frame: 1-month follow-up ]
    Assessed via the Alcohol Use Self-Protective Behavior Scale

  7. Psychological barriers to resistance [ Time Frame: 1-month follow-up ]
    Assessed via the Psychological Barriers to Resistance Instrument


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 24 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between the ages of 18 and 24
  • Enrolled as a student at one of the study sites

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Happy People Games, LLC
Clemson University
Investigators
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Principal Investigator: Sharon Wood Happy People Games
More Information
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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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Happy People Games, LLC:
Sexual Assault
Digital Intervention