Safety and Effectiveness Study: Role Playing Game for Fri... | NCT01807806

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

NCT01807806

Sponsor

University of Southern California

Status

Completed

Last Update Posted

May 5, 2017Actual

Enrollment

65Actual

Phase

Not Applicable

Conditions

Communication

Interventions

Role-playing game

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Mar 5, 2013

First Submission Date that Met QC Criteria

Mar 6, 2013

First Posted Date

Mar 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2017

Last Update Posted Date

May 5, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maryalice Jordan-Marsh, Associate professor, University of Southern CaliforniaPrincipal Investigator

Lead Sponsor

University of Southern CaliforniaOTHER

Collaborators

Name	Class
Soar Technology	UNKNOWN
Creative Media and Behavioral Health Center	UNKNOWN
USC Center for Innovation and Research on Veterans & Military Families	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Role-playing game	Experimental	All eligible participants were invited to play the role playing game	Behavioral: Role-playing game

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

86 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maryalice Jordan-Marsh, PhD	University of Southern California	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Southern California School of Social Work		Los Angeles	California	90089	United States