OnTrack>An Online Role-Playing Game: A Small Business Innovation Research (SBIR) Grant

Our team will develop a prototype game (OnTrack>The Game) in which users play the role of a person who has experienced First Episode Psychosis and move through animated role-playing scenarios, learning practical tips for engaging in care, playing mini-games to develop self- advocacy skills, and seeing stories of hope and recovery (brief video vignettes). The game is designed in an engaging comic book style in which the player is presented with realistic situations designed to promote engagement and the development of trusting relationships.

Following development of the prototype, the investigators will conduct a pilot study to develop preliminary data to determine feasibility of a large-scale Phase 2 effectiveness study. This pilot study aims to demonstrate proof of concept for OnTrack>The Game. The investigators will recruit a sample of patients/consumers (n=25) from OnTrackNY sites that offer services for those experiencing their first psychotic episode. Quantitative data will be collected through baseline and follow up surveys that utilize instruments to measure knowledge and attitudes about recovery, perceptions of stigma, feelings of empowerment and sense of hopefulness. The investigators will also conduct semi-structured interviews with a subset of participants to explore engagement in treatment and attitudes toward the game.

Study Overview

Detailed Description

In light of research supporting early first episode psychosis (FEP) intervention models as well as the efficacy of video gaming to engage young people with FEP in treatment, the connection between the two needs to be explored. A gaming tool for first-episode psychosis has the potential to improve patient care; and, decrease stigma associated with schizophrenia.

Hypothesis:

The investigators hypothesize that Phase 1 of this study will demonstrate that the videogame is comprehensible, engaging and easy to maneuver. The investigators hypothesize that the results from the pilot study will suggest that this technologically innovative tool has potential to enhance positive outcomes of research-tested interventions, such as OnTrackNY, for individuals with FEP.

Approach:

Our team will develop a prototype game (OnTrack>The Game) in which users play the role of a person who has experienced FEP and move through animated role-playing scenarios, learning practical tips for engaging in care, playing mini-games to develop self- advocacy skills, and seeing stories of hope and recovery (brief video vignettes). The game is designed in an engaging comic book style in which the player is presented with realistic situations designed to promote engagement and the development of trusting relationships.

Following development of the prototype, the investigators will conduct a pilot study to develop preliminary data to determine feasibility of a large-scale Phase 2 effectiveness study. This pilot study aims to demonstrate proof of concept for OnTrack>The Game. The investigators will recruit a sample of patients/consumers (n=25) from OnTrackNY sites that offer services for those experiencing their first psychotic episode. Quantitative data will be collected through baseline and follow up surveys that utilize instruments to measure knowledge and attitudes about recovery, perceptions of stigma, feelings of empowerment and sense of hopefulness. The investigators will also conduct semi-structured interviews with a subset of participants to explore engagement in treatment and attitudes toward the game.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Needham, Massachusetts, United States, 02494
        • Center for Social Innovation
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria (Consumers):

  • 18 - 30 years of age;
  • have experienced a first episode of psychosis;
  • have been referred to OnTrack New York in the past 12 months;
  • are willing to complete study requirements; and
  • provides informed consent

Exclusion Criteria (Consumers):

  • non-English speaker;
  • not clinically stable (at risk of self harming or others, and/or experiencing elevated symptoms) and incapable of providing informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pilot test Intervention OnTrack>The Game

Consumers who have been referred to OnTrackNY sites at Washington Heights Community Service or Mental Health Association Westchester in the past six months will be recruited to participate in a product evaluation of OnTrack>The Game.

Intervention: This is a behavioral/attitudinal intervention, using OnTrack>The Game, which will include each participant sitting down at a computer for approximately one hour (over the course of one week) to complete the prototype game. Users will take on the role of a person who has experienced first-episode psychosis and moves through animated role-playing scenarios, learn practical tips for engaging in care, play mini-games to develop self-advocacy skills, and view stories of hope and recovery (brief video vignettes).

The intervention will involve each participant sitting down at a computer for approximately one hour (over the course of one week) to complete the prototype game. Users will take on the role of a person who has experienced first-episode psychosis and moves through animated role-playing scenarios, learn practical tips for engaging in care, play mini-games to develop self-advocacy skills, and view stories of hope and recovery (brief video vignettes).

While the intervention does not require direct supervision by the research team, technical support will be available for the duration of the study via telephone, instant messaging and email. All participants receive identical baseline surveys and 2-week follow up surveys.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in attitudes toward recovery
Time Frame: Pre and post game play; timeframe: Months 9 and 10 (weeks 36 and 40)
The Herth Hope Index (HHI) will be employed to assess hope in adults immediately before (Month 9; week 36) and 2 weeks (Month 10; week 40) following game play. The instrument is a 12-item survey adapted from the Herth Hope Scale (HHS) (Herth, 1992). The Recovery Attitudes Questionnaire (RAQ-16) will also be used, which helps consumers identify and think about their beliefs and attitudes toward recovery. The instrument is a 16-item survey that will be employed immediately before (week 36) and 2 weeks after game play (week 40) (Borkin et al, 2000).
Pre and post game play; timeframe: Months 9 and 10 (weeks 36 and 40)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sense of stigma and empowerment
Time Frame: Month 10 (week 40)
(1) The self-stigma of mental illness survey (short form) (Corrigan et al, 2012) and (2) empowerment survey will be used both immediately before game play (weeks 36) and 2-weeks (week 40) following game play (Rogers, 1997).
Month 10 (week 40)
Increased engagement in treatment
Time Frame: Post game play; timeframe: Month 10 (week 40)
Semi-structured interviews will be conducted with a subset of participants to explore access to treatment and potential barriers.
Post game play; timeframe: Month 10 (week 40)
Attitudes toward the game
Time Frame: Post game play; timeframe: Month 10 (week 40)
Semi-structured interviews will take place with a subset of participants to explore their experience playing the game and attitudes toward it (e.g. extent to which they can relate to it; satisfaction; usability).
Post game play; timeframe: Month 10 (week 40)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

April 13, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 1R43MH105013-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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