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Completed

NCT Number: NCT02415764

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.

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Key information

Conditions

Psychosis Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Center for Social Innovation, Needham, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral/Attitudinal OnTrack Role-Playing Game

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Center for Social Innovation, Massachusetts

Other

Collaborators

  • Research Foundation for Mental Hygiene, Inc.

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 14, 2015
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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