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

Primary Purpose

Psychosis, Schizoaffective Disorder, Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OnTrack>TheGame (OTG)
Recovery Videos (RV)
Sponsored by
Center for Social Innovation, Massachusetts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Psychosis

Eligibility Criteria

16 Years - 30 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

OnTrack>TheGame (OTG)

Recovery Videos (RV)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Treatment Engagement
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)
Empowerment
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)
Stigma
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)

Secondary Outcome Measures

Empowerment and Stigma Mediating Effect on Treatment Engagement
Do increases in empowerment and decreases in stigma concerns mediate the effect of OTG on treatment engagement

Full Information

First Posted
December 19, 2017
Last Updated
November 24, 2021
Sponsor
Center for Social Innovation, Massachusetts
Collaborators
Research Foundation for Mental Hygiene, Inc., New York State Psychiatric Institute, University of Maryland, College Park, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03390491
Brief Title
OnTrack>An Online Role-Playing Game for Young People With First Episode Psychosis
Official Title
OnTrack>An Online Role-Playing Game for Young People With First Episode Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Social Innovation, Massachusetts
Collaborators
Research Foundation for Mental Hygiene, Inc., New York State Psychiatric Institute, University of Maryland, College Park, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Schizoaffective Disorder, Schizophrenia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OnTrack>TheGame (OTG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Recovery Videos (RV)
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
OnTrack>TheGame (OTG)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Recovery Videos (RV)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Treatment Engagement
Description
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)
Time Frame
At time point 3 (five months after baseline)
Title
Empowerment
Description
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)
Time Frame
at time point 2 (two months after baseline); and at time point 3 (five months after baseline)
Title
Stigma
Description
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)
Time Frame
at time point 3 (five months after baseline)
Secondary Outcome Measure Information:
Title
Empowerment and Stigma Mediating Effect on Treatment Engagement
Description
Do increases in empowerment and decreases in stigma concerns mediate the effect of OTG 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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bethany Marcogliese, PhD
Organizational Affiliation
Center for Social Innovation
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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OnTrack>An Online Role-Playing Game for Young People With First Episode Psychosis

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