OnTrack>An Online Role-Playing Game for Young People With First Episode Psychosis

November 24, 2021 updated by: Center for Social Innovation, Massachusetts
The research team will develop and test a prototype version of OnTrack>An Online Role-Playing Game (OnTrack>The Game or OTG), an online role-playing game designed for youth and young adults experiencing First Episode Psychosis (FEP). Phase I showed positive changes in quantitative measures of hope and recovery, as well as an enthusiastic response to the prototype as evidenced by qualitative interviews. In Phase II, the research team will refine, expand and finalize OTG and evaluate the effectiveness of OTG.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed mixed-methods Phase II study will use standardized measures and semi-structured qualitative interviews to achieve the following aims:

  1. Product aim: To refine, expand, and finalize OnTrack>The Game. Building on the Phase I prototype, the investigators will improve functionality, expand the play spaces and levels, add interaction with non-player characters, include more resources on FEP, and expand the library of videos on hope and recovery.

  2. Primary research aim: To evaluate the effectiveness of a role-playing game (OTG) in increasing empowerment, decreasing stigma concerns, and improving treatment engagement.

    Hypothesis 1: Compared to control condition (Recovery Videos, or RV), participants in OTG will report significantly increased empowerment at 2 months post-intervention compared to baseline.

    Hypothesis 2: Compared to the control condition (RV), participants randomized to the OTG condition will report significantly increased empowerment, decreased stigma concerns, and greater treatment engagement at the 5-month follow-up compared to baseline.

  3. Secondary research aim: To determine if changes in empowerment and stigma concerns mediate the effect of OnTrack>The Game on treatment engagement.

Hypothesis 3: Increases in hope, attitudes toward treatment, and self-efficacy and decreases in stigma concerns at post treatment will partially mediate the improvement in treatment engagement at follow-up.

Approach

Overview and Rationalization of Study Design: Phase II is a randomized controlled trial (RCT) enrolling 200 clients randomized to OTG or a control condition of RVs in a 1:1 ratio. The investigators will recruit these participants from OnTrackNY's Early Intervention for Psychosis (EIP) clinical centers after screening for eligibility. After consent and Baseline data collection, participants will be randomly assigned to either OTG or RV, which will be available to them for two months. Following an intent-to-treat framework, the investigators will then assess each client participant at 2 additional time points regardless of participation in their assigned condition: post-intervention (immediately after the 2 month intervention has completed), then follow-up at 3 months post-intervention.

Ten clinicians working with these clients will also be recruited for semi-structured key informant qualitative interviews. Twenty client interviews will also be conducted, 10 from each condition. The investigators' rationale for selecting a randomized controlled design stems from Phase I findings, which suggest that the game may be effective in addressing young people's hopefulness, stigma, and understanding around first episode psychosis. An RCT design will allow the research team to examine how specific aspects of the game impact outcomes in these areas, as compared to more static, passive online resource.

Study Setting: OnTrackNY is New York State's coordinated specialty care (CSC) program. Funded by state dollars, a SAMHSA Health Transitions Grant, and Mental Health Block Grant funds, the state currently supports 13 teams throughout the state. Eight additional programs are expected to come on line within the next 6 months. The program serves young adults ages 16 to 30. To date, a total of 290 individuals have been enrolled. Across the sites, clients are 69% male; mean age of 21; 19% are under the age of 18; racial/ethnic breakdown is as follows: 42% White, 39% Black, 10% Asian, 9% Other, and 23% Hispanic.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

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

  • United States
    • 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

16 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Client inclusion criteria:

  • Currently enrolled in OnTrackNY
  • English speaking
  • Clinically stable (not in crisis or experiencing severe or elevated symptoms)
  • Capable of providing informed consent
  • Regular access to a computer or tablet (at home or at their OnTrack site)
  • Working email address and access to email
  • Enrolled in OnTrackNY less than 19 months
  • Parent or guardian permission for minors (age 16-17)

Exclusion Criteria for Clients:

• Not meeting inclusion criteria. No other exclusion criteria.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OnTrack>TheGame (OTG)
Participants randomized to the OTG group (n=100) will have the option to play the online role-playing game for a period of 2 months. They will receive weekly email reminders that the game remains available to them.
Behavioral: OnTrack>TheGame (OTG)
OTG clients will be informed that the game can be played on a computer or a tablet and the time estimate for completing the game is approximately 5-8 hours. OnTrack>The Game offers players the opportunity to immerse in a fictional neighborhood that centers around four domains for supportive recovery as defined by SAMHSA: health, home, purpose and community. The player interacts with other game characters including new acquaintances, friends/peers, a family member, and a treatment team, allowing the player to practice social and communication skills, while fostering personal relationships and building a support network. Additionally, the game provides players with helpful resources including psychoeducation materials and videos of real people who have experienced a first episode of psychosis, sharing their stories of hope and recovery. As a whole, the game provides a safe environment to promote goal attainment and recovery.
Other: Recovery Videos (RV)
Participants randomized to the RV group (n=100) will have the option to visit a website that will contain the recovery videos and the static information that is contained in the game. The RV group will also have 2 months to view the materials on the website and will receive weekly email reminders that the website/videos remain available to them. At the end of the study (after the follow-up assessment), the RV participants will be provided access to the game.
Behavioral: Recovery Videos (RV)
As described, RV clients will have access to a website that includes recovery videos and static psychoeducation materials. In this condition, mental health providers will also ask about possible reactions to viewing the recovery videos and information on the website.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Treatment Engagement
Time Frame: At time point 3 (five months after baseline)
Improved treatment engagement in participants from OTG condition compared to the control condition, RV (measured by a. Signh O'Brien Level of Engagement Scale, b. Engagement with CSC program determined by record review)
At time point 3 (five months after baseline)
Empowerment
Time Frame: at time point 2 (two months after baseline); and at time point 3 (five months after baseline)
Increased empowerment in participants from OTG condition compared to the control condition, RV (measured by: a. Herth Hope Index, b. Recovery Attitude Questionnaire, c. Roger's Empowerment Scale)
at time point 2 (two months after baseline); and at time point 3 (five months after baseline)
Stigma
Time Frame: at time point 3 (five months after baseline)
Decreased stigma concerns in participants from OTG condition compared to the control condition, RV (measured by a. Questionnaire on Anticipated Stigma, b. Rüsch Stigma Stress)
at time point 3 (five months after baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Empowerment and Stigma Mediating Effect on Treatment Engagement
Time Frame: do increases in empowerment and decreases in stigma concerns at time point 2 (2 months after baseline), mediate the effect of OTG on treatment engagement at time point 3 (5 months after baseline)
Do increases in empowerment and decreases in stigma concerns mediate the effect of OTG on treatment engagement
do increases in empowerment and decreases in stigma concerns at time point 2 (2 months after baseline), mediate the effect of OTG on treatment engagement at time point 3 (5 months after baseline)

Collaborators and Investigators

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

Sponsor

Center for Social Innovation, Massachusetts

Collaborators

National Institute of Mental Health (NIMH)
New York State Psychiatric Institute
Research Foundation for Mental Hygiene, Inc.
University of Maryland, College Park

Investigators

  • Principal Investigator: Bethany Marcogliese, PhD, Center for Social Innovation

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.

General Publications

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 (Actual)

November 1, 2018

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

December 28, 2017

First Posted (Actual)

January 4, 2018

Study Record Updates

Last Update Posted (Actual)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #7643
  • 2R44MH105013-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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