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临床试验/NCT03390491
NCT03390491已完成不适用

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

Center for Social Innovation, Massachusetts1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
试验地点
1
主要终点
Change in Treatment Engagement

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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)

排除标准

  • •for Clients:
  • •Not meeting inclusion criteria. No other exclusion criteria.

研究组 & 干预措施

OnTrack>TheGame (OTG)

Experimental

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.

干预措施: OnTrack>TheGame (OTG) (Behavioral)

Recovery Videos (RV)

Other

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.

干预措施: Recovery Videos (RV) (Behavioral)

结局指标

主要结局

Change in Treatment Engagement

时间窗: 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

时间窗: 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

时间窗: 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)

次要结局

  • Empowerment and Stigma Mediating Effect on Treatment Engagement(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))

研究者

发起方
Center for Social Innovation, Massachusetts
申办方类型
Other
责任方
Sponsor

研究点 (1)

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