Clinical trial NCT03820609: Interactive Digital Intervention to Prevent Violence Among Young Adults
Official title: Interactive Digital Intervention to Prevent Violence Among Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Assault
Keywords: Sexual Assault
Digital Intervention
Lead sponsor: Happy People Games, LLC
Sponsor class: OTHER
Collaborators: name: Clemson University
First posted: 2019-01-29
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Sexual aggression
timeFrame: 1-month follow-up
measure: Sexual victimization
timeFrame: 1-month follow-up
measure: Bystander intervention
timeFrame: 1-month follow-up
Secondary outcomes:
measure: Rape supportive beliefs
timeFrame: 1-month follow-up
measure: Perception of peer support for sexual aggression
timeFrame: 1-month follow-up
measure: Perceived peer norms
timeFrame: 1-month follow-up
measure: Bystander intervention confidence
timeFrame: 1-month follow-up
measure: Communication of consent
timeFrame: 1-month follow-up
measure: Self-protective behavior
timeFrame: 1-month follow-up
measure: Psychological barriers to resistance
timeFrame: 1-month follow-up
Other outcomes:
Locations:
city: Warwick
country: United States
facility: Community College of Rhode Island
state: Rhode Island
city: Clemson
country: United States
facility: Clemson University
state: South Carolina
Study officials:
affiliation: Happy People Games
name: Sharon Wood
role: PRINCIPAL_INVESTIGATOR
References: