Interactive Digital Intervention to Prevent Violence Among Young Adults

NCT03820609 | Completed DMC

• 1 other identifier: HappyPeopleGames
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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.

Conditions

Sexual Assault

Keywords

Sexual Assault; Digital Intervention

Outcome Measures

Primary Outcomes (3)

• Sexual aggression

  Assessed via the Sexual Experiences Survey - Revised

  1-month follow-up

• Sexual victimization

  Assessed via the Sexual Experiences Survey - Revised

  1-month follow-up

• Bystander intervention

  Assessed via the Bystander Attitudes Survey

  1-month follow-up

Secondary Outcomes (7)

• 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

Study Arms (1)

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.

Behavioral: Digital Intervention

Interventions

Digital Intervention BEHAVIORAL

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

Digital Intervention

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Happy People Games, LLC: lead
• Clemson University: collaborator

Study Sites (2)

Community College of Rhode Island

Warwick, Rhode Island, 02886, United States

Location

Clemson University

Clemson, South Carolina, 29634, United States

Location

Study Officials

• Sharon Wood

  Happy People Games

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: January 29, 2019
• Study Start: June 5, 2018
• Primary Completion: July 15, 2018
• Study Completion: August 15, 2018
• Last Updated: April 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)