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Completed

NCT Number: NCT01807806

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

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.

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Key information

Conditions

Communication Behavior

Age range

18 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California School of Social Work

Los Angeles, California, 90089, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Role-playing game

Behavioral

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.

Primary outcomes

  1. Change from Baseline in mental health status at one week

    Time frame: One week

    Patient Health Questionnaire (PHQ) Depression Scale

Secondary outcomes

  1. Change from intervention in task-based motivation at one week

    Time frame: Intervention, one week

    Intrinsic Motivation Inventory

Other outcomes

  1. change from baseline to knowledge of best practices for post deployment conversations at one week

    Time frame: one week

    A knowledge acquisition inventory of strategies for approaching service members with post deployment readjustment issues

  2. Change in anxiety from immediately after the intervention to rating one week later

    Time frame: one week

    visual analogue scale

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Creative Media and Behavioral Health Center
  • Soar Technology
  • USC Center for Innovation and Research on Veterans & Military Families

Registry information

Official study title

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

Acronym: RPG

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 8, 2013
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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