Interactive Digital Intervention to Prevent Violence Among Young Adults

Sexual Assault Clinical Trial

Official title:

Interactive Digital Intervention to Prevent Violence Among Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03820609
• Other study ID #: HappyPeopleGames
• Status: Completed
• Phase: N/A
• Start date: June 5, 2018
• Est. completion date: August 15, 2018

Study information

• Verified date: April 2019
• Source: Happy People Games, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 15, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

Inclusion Criteria:

• Between the ages of 18 and 24

• Enrolled as a student at one of the study sites

Exclusion Criteria:

Related Conditions & MeSH terms

• Sexual Assault

Intervention

Behavioral:
• Digital Intervention
This digital application for sexual assault prevention can be completed on a tablet computer.

Locations

Country	Name	City	State
United States	Clemson University	Clemson	South Carolina
United States	Community College of Rhode Island	Warwick	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Happy People Games, LLC	Clemson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual aggression	Assessed via the Sexual Experiences Survey - Revised	1-month follow-up
Primary	Sexual victimization	Assessed via the Sexual Experiences Survey - Revised	1-month follow-up
Primary	Bystander intervention	Assessed via the Bystander Attitudes Survey	1-month follow-up
Secondary	Rape supportive beliefs	Assessed via the Short-Form Illinois Rape Myth Acceptance Scale	1-month follow-up
Secondary	Perception of peer support for sexual aggression	Assess through items from Boeringer's Social Norms Measure and Clemson's Peer Pressure Measure	1-month follow-up
Secondary	Perceived peer norms	Change in the accuracy in perception of peer norms (assessed via responses to in-app questions)	1-month follow-up
Secondary	Bystander intervention confidence	Assessed via the Bystander Efficacy Scale from ARC-3	1-month follow-up
Secondary	Communication of consent	Assessed via the Consent Experiences Scale	1-month follow-up
Secondary	Self-protective behavior	Assessed via the Alcohol Use Self-Protective Behavior Scale	1-month follow-up
Secondary	Psychological barriers to resistance	Assessed via the Psychological Barriers to Resistance Instrument	1-month follow-up