OnTrack>An Online Role-Playing Game for Young People With First Episode Psychosis
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|ClinicalTrials.gov Identifier: NCT03390491|
Recruitment Status : Not yet recruiting
First Posted : January 4, 2018
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Psychosis Schizoaffective Disorder Schizophrenia||Behavioral: OnTrack>TheGame (OTG) Behavioral: Recovery Videos (RV)||Not Applicable|
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.
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 (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||OnTrack>An Online Role-Playing Game for Young People With First Episode Psychosis|
|Estimated Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||February 29, 2020|
|Estimated Study Completion Date :||February 29, 2020|
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.
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.
- 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)
- 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)
- 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)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390491
|Contact: Lisa Carlucci Thomas, MSfirstname.lastname@example.org|
|Contact: Kathleen Ferreira, PhDemail@example.com|
|United States, New York|
|New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Lisa Carlucci Thomas, MS||Center for Social Innovation|