Safety and Effectiveness Study: Role Playing Game for Friends and Family of Service Members

Communication Clinical Trial

— RPG  

Official title:

Safety and Effectiveness Study: Interactive Game-Based System for Psychological Health Education

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807806
• Other study ID #: USC Subcontract No 10150.003.0
• Status: Completed
• Phase: N/A
• First received: March 5, 2013
• Last updated: May 2, 2017
• Start date: March 2013
• Est. completion date: July 2013

Study information

• Verified date: May 2017
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project is a partnership between Soar Technology, the University of Southern California (USC) Center for Innovation and Research on Veterans and Military Families (CIR) and the USC Creative Media and Behavioral Health Center (CM&BHC) to conduct a Safety and Effectiveness Study (SES) for an educational role-playing game developed by Soar Technology, Inc. The purpose of the intervention to be delivered by Soar Technology is to educate families and friends with the ultimate goal of empowering them to have a conversation with the veteran/service member about readjustment issues. The study will assess the safety and effectiveness of the provided game using personal interviews, play testing, and surveys. The game playing experience is hypothesized to be safe and effective with respect to having conversations with veterans/service members following deployment.

Description:

The intervention is a multi-scenario role playing simulation. Participants view the scenario and answer questions about what has been displayed as typical for post deployment service members. Participants receive immediate feedback with respect to expectations set by simulation developers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 86 Years

Eligibility

Inclusion Criteria:

• must be friend or family member to a military veteran or service member who experienced a deployment no earlier than 2007, or who are currently active and have recently returned from a deployment

• be able to read English

• be reachable via cell phone

• age range 18-86

• daily access to the internet

• have a personal email account for contact

• experience with filling out online surveys, or online shopping, or social media, or playing digital games

Exclusion Criteria:

• no acute psychopathology based on PHQ-9 and VAS scores at baseline and VAS and PHQ-2 at pre-test

• must not be active duty military personnel or a veteran at the time of the study

• service member or self is not currently receiving treatment at VA or other mental health facility

Related Conditions & MeSH terms

• Communication

Intervention

Behavioral:
• Role-playing game
Eligible participants will be invited to engage with a role-playing game for 30 minutes. The role play presents situations where a service member/veteran interacts with family or friends.

Locations

Country	Name	City	State
United States	University of Southern California School of Social Work	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
University of Southern California	Center for Innovation and Research on Veterans and Military Families, Creative Media and Behavioral Health Center, Soar Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change from baseline to knowledge of best practices for post deployment conversations at one week	A knowledge acquisition inventory of strategies for approaching service members with post deployment readjustment issues	one week
Other	Change in anxiety from immediately after the intervention to rating one week later	visual analogue scale	one week
Primary	Change from Baseline in mental health status at one week	Patient Health Questionnaire (PHQ) Depression Scale	One week
Secondary	Change from intervention in task-based motivation at one week	Intrinsic Motivation Inventory	Intervention, one week