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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Communication

Intervention / Treatment
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* Behavioral: Role-playing game


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 86 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Role-playing game<br>All eligible participants were invited to play the role playing game | Behavioral: Role-playing game<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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veterans, military, families