NCT02415764

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

9 months

First QC Date

March 30, 2015

Last Update Submit

July 26, 2016

Conditions

PsychosisSchizoaffective DisorderSchizophrenia

Outcome Measures

Primary Outcomes (1)

  • Changes in attitudes toward recovery

    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 Outcomes (3)

  • Sense of stigma and empowerment

    Month 10 (week 40)

  • Increased engagement in treatment

    Post game play; timeframe: Month 10 (week 40)

  • Attitudes toward the game

    Post game play; timeframe: Month 10 (week 40)

Study Arms (1)

Pilot test Intervention OnTrack>The Game

OTHER

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).

Behavioral: Behavioral/Attitudinal OnTrack Role-Playing Game

Interventions

Behavioral/Attitudinal OnTrack Role-Playing GameBEHAVIORAL

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.

Pilot test Intervention OnTrack>The Game

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Social Innovation

Needham, Massachusetts, 02494, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (4)

  • Borkin, J. R., Stefffen, J. J., Ensfield, K. K., Wishnick, H., Wilder, K. & Yangarber, N. (2000) Recovery attitudes questionnaire: Development and evaluation. Psychiatric Rehabilitation Journal, 24(2), 95-102

    BACKGROUND

  • Corrigan PW, Michaels PJ, Vega E, Gause M, Watson AC, Rusch N. Self-stigma of mental illness scale--short form: reliability and validity. Psychiatry Res. 2012 Aug 30;199(1):65-9. doi: 10.1016/j.psychres.2012.04.009. Epub 2012 May 10.

    PMID: 22578819BACKGROUND

  • Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9. doi: 10.1111/j.1365-2648.1992.tb01843.x.

    PMID: 1430629BACKGROUND

  • Rogers ES, Chamberlin J, Ellison ML, Crean T. A consumer-constructed scale to measure empowerment among users of mental health services. Psychiatr Serv. 1997 Aug;48(8):1042-7. doi: 10.1176/ps.48.8.1042.

    PMID: 9255837BACKGROUND

MeSH Terms

Conditions

Psychotic DisordersSchizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Jeffrey Olivet, MA

    Center for Social Innovation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 14, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

July 27, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)