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Trial record 47 of 4761 for:    Recruiting, Not yet recruiting, Available Studies | "Psychotic Disorders"

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
Sponsor:
Collaborators:
Research Foundation for Mental Hygiene, Inc.
New York State Psychiatric Institute
University of Maryland
National Institute of Mental Health (NIMH)
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 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)


Secondary Outcome Measures :
  1. 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



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:

  • 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.


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: Lisa Carlucci Thomas, MS 203-836-6842 lcthomas@center4si.com
Contact: Kathleen Ferreira, PhD 352-212-2616 kferreira@center4si.com

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
Center for Social Innovation, Massachusetts
Research Foundation for Mental Hygiene, Inc.
New York State Psychiatric Institute
University of Maryland
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Lisa Carlucci Thomas, MS Center for Social Innovation

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: #7643
2R44MH105013-02 ( U.S. NIH Grant/Contract )
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 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