跳至主要内容
临床试验/NCT03820609
NCT03820609已完成不适用

Interactive Digital Intervention to Prevent Violence Among Young Adults

Happy People Games, LLC2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2018年6月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
41
试验地点
2
主要终点
Sexual aggression

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

盲法说明

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.

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

Digital Intervention

Experimental

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.

干预措施: Digital Intervention (Behavioral)

结局指标

主要结局

Sexual aggression

时间窗: 1-month follow-up

Assessed via the Sexual Experiences Survey - Revised

Sexual victimization

时间窗: 1-month follow-up

Assessed via the Sexual Experiences Survey - Revised

Bystander intervention

时间窗: 1-month follow-up

Assessed via the Bystander Attitudes Survey

次要结局

  • Rape supportive beliefs(1-month follow-up)
  • Perception of peer support for sexual aggression(1-month follow-up)
  • Perceived peer norms(1-month follow-up)
  • Bystander intervention confidence(1-month follow-up)
  • Communication of consent(1-month follow-up)
  • Self-protective behavior(1-month follow-up)
  • Psychological barriers to resistance(1-month follow-up)

研究者

发起方
Happy People Games, LLC
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验