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

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

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.

Study Overview

• Status: Completed
• Conditions: Communication
• Intervention / Treatment: Behavioral: Role-playing game

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90089
      • University of Southern California School of Social Work

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Role-playing game; All eligible participants were invited to play the role playing game	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in mental health status at one week	Patient Health Questionnaire (PHQ) Depression Scale	One week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from intervention in task-based motivation at one week	Intrinsic Motivation Inventory	Intervention, one week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in anxiety from immediately after the intervention to rating one week later	visual analogue scale	one week

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Soar Technology; Creative Media and Behavioral Health Center; USC Center for Innovation and Research on Veterans & Military Families
• Investigators: Principal Investigator: Maryalice Jordan-Marsh, PhD, University of Southern California

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: March 5, 2013
• First Submitted That Met QC Criteria: March 6, 2013
• First Posted (Estimate): March 8, 2013

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: veterans, military, families
• Other Study ID Numbers: USC Subcontract No 10150.003.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No