Clinical trial NCT03390491: 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
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Schizoaffective Disorder
Schizophrenia
Lead sponsor: Center for Social Innovation, Massachusetts
Sponsor class: OTHER
Collaborators: name: Research Foundation for Mental Hygiene, Inc.
name: New York State Psychiatric Institute
name: University of Maryland, College Park
name: National Institute of Mental Health (NIMH)
First posted: 2018-01-04
Enrollment: 160
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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:

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.

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.

Primary outcomes:
measure: Change in Treatment Engagement
timeFrame: At time point 3 (five months after baseline)
measure: Empowerment
timeFrame: at time point 2 (two months after baseline); and at time point 3 (five months after baseline)
measure: Stigma
timeFrame: at time point 3 (five months after baseline)
Secondary outcomes:
measure: Empowerment and Stigma Mediating Effect on Treatment Engagement
timeFrame: 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)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Center for Social Innovation
name: Bethany Marcogliese, PhD
role: PRINCIPAL_INVESTIGATOR
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