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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 : January 10, 2018
Sponsor:
Collaborator:
Research Foundation for Mental Hygiene, Inc.
Information provided by (Responsible Party):
Center for Social Innovation, Massachusetts

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.

Condition or disease Intervention/treatment Phase
Psychosis Schizoaffective Disorder Schizophrenia Behavioral: OnTrack>TheGame (OTG) Behavioral: Recovery Videos (RV) Not Applicable

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 they will receive 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. 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: OnTrack>An Online Role-Playing Game for Young People With First Episode Psychosis
Estimated Study Start Date : April 17, 2018
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OnTrack>TheGame (OTG)
The intervention condition will consist of 2 components: (1) provision of the game to the participating clients via an email link, and (2) brief interactions with their mental health provider with respect to reactions they may have when playing the game. Components of the game are described in the Innovation section. The participant will be reminded via email once a week to play the game/visit the website for a period of 2 months. After that time, reminders to play the game/visit website will no longer be sent, but the participant may continue to play if they wish.
Behavioral: OnTrack>TheGame (OTG)
The intervention condition will consist of 2 components: (1) provision of the game to the participating clients via an email link, and (2) brief interactions with their mental health provider with respect to reactions they may have when playing the game. Components of the game are described in the Innovation section. The participant will be reminded via email once a week to play the game/visit the website for a period of 2 months. After that time, reminders to play the game/visit website will no longer be sent, but the participant may continue to play if they wish.

Recovery Videos (RV)
The comparator will consist of access to a website that will contain the recovery videos and the static information that is contained in the game. In this condition, mental health providers will also ask about possible reactions to viewing the recovery videos and information on the website. 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)
This study condition will consist of access to a website that will contain the recovery videos and the static information that is contained in the game. In this condition, mental health providers will also ask about possible reactions to viewing the recovery videos and information on the website.




Primary Outcome Measures :
  1. Change in Treatment Engagement [ Time Frame: Baseline (beginning of Month 1), immediately after the 2-month intervention (end of Month 2), and a Follow-Up at 3 months post-intervention (end of Month 5/beginning of Month 6) ]
    Singh O'Brien Level of Engagement Scale (SOLES); Calculated as mean of all non-missing items with a range of 0-10. A higher score indicates stronger engagement in treatment.


Secondary Outcome Measures :
  1. Change in Concerns Related to Stigma [ Time Frame: Baseline (Month 1), Post (end of Month 2), and Follow-Up (end of Month 5/beginning of Month 6) ]
    Rüsch Stigma Stress; Questionnaire on Anticipated Discrimination

  2. Change in Sense of Empowerment [ Time Frame: Baseline (Month 1), Post (end of Month 2), and Follow-Up (end of Month 5/beginning of Month 6) ]
    Roger's Empowerment Scale Total; The scale has 5 sub-scales (self-esteem-self-efficacy; power-powerlessness; community activism and autonomy; optimism and control over the future; righteous anger.) Each sub-scale ranges from 1-4 and is summed and averaged for the total score. The range of 1-4 represents a Likert scale with 1 meaning "strongly agree" and 4 meaning "strongly disagree." The lower the level of empowerment, the higher the score.

  3. Change in Recovery Attitude [ Time Frame: Baseline (Month 1), Post (end of Month 2), and Follow-Up (end of Month 5/beginning of Month 6) ]
    Recovery Attitude Questionnaire (RAQ)

  4. Change in Sense of Hope [ Time Frame: Baseline (Month 1), Post (end of Month 2), and Follow-Up (end of Month 5/beginning of Month 6) ]
    Herth Hope Index (HHI)

  5. Number of unduplicated visits [ Time Frame: Data will be collected at Follow-Up (end of Month 5/beginning of Month 6) ]
    Number of unduplicated visits during the follow-up period



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Client inclusion criteria:

  • Individuals currently enrolled in OnTrackNY who wish to enroll;
  • Must be between the age of 16 and 30;
  • Must be receiving services at one of the host sites;
  • Must be able to give fully-informed consent;
  • Must be willing and available to take part in the intervention conditions, 3 in person quantitative assessments, and possibly a semi-structured qualitative interview;
  • Must be engaged in the EIP program for less than a year;
  • Must have access to the internet with a personal computer or tablet (if this is a barrier, sites can provide access);
  • Must have access to email; and
  • Must be English speaking.

Clinician inclusion criteria:

  • Must be a mental health professionals providing care in a host site and working with a client participating in the study;
  • Must be willing to complete study requirements and provide signed informed consent;
  • Must be English speaking.

Exclusion Criteria for Clients and Clinicians:

• Not meeting inclusion criteria. No other exclusion criteria.


Information from the National Library of Medicine

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


Contacts
Contact: Jeffrey Olivet, MA 617-467-6014 jolivet@center4si.com
Contact: Kathleen Ferreira, PhD 352-212-2616 kferreira@center4si.com

Sponsors and Collaborators
Center for Social Innovation, Massachusetts
Research Foundation for Mental Hygiene, Inc.
Investigators
Principal Investigator: Jeffrey Olivet, MA Center for Social Innovation
  Study Documents (Full-Text)

Documents provided by Center for Social Innovation, Massachusetts:

Publications:
Stroup, T. S., Lawrence, R. E., Abbas, A. I., Miller, B. R., Perkins, D. O., Lieberman J. A. (2013). Schizophrenia spectrum and other psychotic disorders. In: R. E. Hales, S. C. Yudofsky, & L. Roberts (Eds.). The American psychiatric publishing textbook of psychiatry (6th ed.). Washington, DC: American Psychiatric Publishing.
Goh, D. H., Ang, R. P., & Tan, H. C. (2008). Strategies for designing effective psychotherapeutic gaming interventions for children and adolescents. Computers in Human Behavior, 24(5), 2217-2235.
Batson, L., & Feinberg, S. (2006). Game designs that enhance motivation and learning for teenagers. Electronic Journal for the Integration of Technology in Education, 5(1), 34-43.
Neal, J.W., Neal, Z.P., VanDyke, E., & Kornbluh, M. (2015). Expediting the analysis of qualitative data in evaluation: A procedure for the Rapid Identification of Themes From Audio Recordings (RITA). American Journal of Evaluation, 36(1), 118-132. doi: 10.1177/1098214014536601

Responsible Party: Center for Social Innovation, Massachusetts
ClinicalTrials.gov Identifier: NCT03390491     History of Changes
Other Study ID Numbers: 2R44MH105013-02 ( U.S. NIH Grant/Contract )
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders