CommunicationRPGNCT01807806
Safety and Effectiveness Study: Role Playing Game for Friends and Family of Service Members
A study testing Role-playing game in people with Communication, run by University of Southern California at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 86 yearsHealthy volunteers can take part
- Conditions the study is for
- Communication
- What is being tested?
- Role-playing game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 86 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California School of Social Work
Los Angeles, California, 90089
About this study
Official title: Safety and Effectiveness Study: Interactive Game-Based System for Psychological Health Education
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.
Read the 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.
- Conditions
- Communication
- Being tested
- Role-playing game
- Keywords
- veterans, military, families
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Role-playing gameBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Role-playing game | Experimental | All eligible participants were invited to play the role playing game Receives: Behavioral: Role-playing game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in mental health status at one week
Patient Health Questionnaire (PHQ) Depression Scale
Measured: One week
Secondary outcomes (1)
Change from intervention in task-based motivation at one week
Intrinsic Motivation Inventory
Measured: Intervention, one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Soar Technology, Creative Media and Behavioral Health Center, USC Center for Innovation and Research on Veterans & Military Families
- Responsible party
- Principal investigator, Maryalice Jordan-Marsh, University of Southern California
- Investigators
- Maryalice Jordan-Marsh, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807806
- Sponsor's protocol ID
- USC Subcontract No 10150.003.0
- Acronym
- RPG
- Status last verified
- May 2017
- First submitted
- 5 Mar 2013
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Study: Interactive Game-Based System for Psychological Health Education
- ClinicalTrials.gov ID
- NCT01807806
- Acronym / sponsor ID
- RPG / USC Subcontract No 10150.003.0
- Conditions
- Communication
- Keywords
- veterans, military, families
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Soar Technology, Creative Media and Behavioral Health Center, USC Center for Innovation and Research on Veterans & Military Families
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Role-playing game | Experimental | Behavioral: Role-playing gameAll eligible participants were invited to play the role playing game |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Role-playing gameEligible 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. | Behavioural | Role-playing game |
Primary outcome
Change from Baseline in mental health status at one week
Time frame: One week
Patient Health Questionnaire (PHQ) Depression Scale
1 secondary outcome
Change from intervention in task-based motivation at one week
Time frame: Intervention, one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryalice Jordan-Marsh, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Role-playing game in people with Communication, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in mental health status at one week (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.