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

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.

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.