Interactive Digital Intervention to Prevent Violence Among Young Adults

NCT ID: NCT03820609

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-05
• Study Completion Date: 2018-08-15

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.

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.

Conditions

Sexual Assault

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Digital Intervention

Intervention Type: BEHAVIORAL

This digital application for sexual assault prevention can be completed on a tablet computer.

Interventions

Digital Intervention

This digital application for sexual assault prevention can be completed on a tablet computer.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clemson University

OTHER

Sponsor Role: collaborator

Happy People Games, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon Wood

Role: PRINCIPAL_INVESTIGATOR

Happy People Games

Locations

Community College of Rhode Island

Warwick, Rhode Island, United States

Clemson University

Clemson, South Carolina, United States

Countries

United States

Other Identifiers

HappyPeopleGames

Identifier Type: -

Identifier Source: org_study_id