Clinical trial NCT01807806: Safety and Effectiveness Study: Role Playing Game for Friends and Family of Service Members
Official title: Safety and Effectiveness Study: Interactive Game-Based System for Psychological Health Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Keywords: veterans, military, families
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Soar Technology
name: Creative Media and Behavioral Health Center
name: USC Center for Innovation and Research on Veterans & Military Families
First posted: 2013-03-08
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in mental health status at one week
timeFrame: One week
Secondary outcomes:
measure: Change from intervention in task-based motivation at one week
timeFrame: Intervention, one week
Other outcomes:
measure: change from baseline to knowledge of best practices for post deployment conversations at one week
timeFrame: one week
measure: Change in anxiety from immediately after the intervention to rating one week later
timeFrame: one week
Locations:
city: Los Angeles
country: United States
facility: University of Southern California School of Social Work
state: California
Study officials:
affiliation: University of Southern California
name: Maryalice Jordan-Marsh, PhD
role: PRINCIPAL_INVESTIGATOR
References: