NCT01807806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

March 5, 2013

Last Update Submit

May 2, 2017

Conditions

Communication

Keywords

veterans, military, families

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in mental health status at one week

    Patient Health Questionnaire (PHQ) Depression Scale

    One week

Secondary Outcomes (1)

  • Change from intervention in task-based motivation at one week

    Intervention, one week

Other Outcomes (2)

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

    one week

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

    one week

Study Arms (1)

Role-playing game

EXPERIMENTAL

All eligible participants were invited to play the role playing game

Behavioral: Role-playing game

Interventions

Role-playing gameBEHAVIORAL

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.

Role-playing game

Eligibility Criteria

Age18 Years - 86 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California School of Social Work

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Maryalice Jordan-Marsh, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 8, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

May 5, 2017

Record last verified: 2017-05

Locations

US(1)