A Digital Game Targeting Suicide Prevention in Adolescents Who Report Substance Misuse (Formative Work and Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Measuring Usability at Post-Gameplay
研究概览
简要总结
The primary aim of this study is to design and develop a digital game that models the process of a safety planning intervention. To do so, the investigators will explore and better understand peer or student perceptions around potential warning signs, coping strategies, and seeking help among youth who may be at greater risk of suicide due to misuse of substances. Focus groups/interviews with adolescents, young adults, adults, and school-based behavioral health providers will be conducted. Findings will inform the development of a digital intervention to reduce the risk of suicide among adolescents who misuse substances. Once a prototype of the game is developed, play-test focus groups with adolescents, college-aged youth, and school-based mental health providers will be conducted to finalize the intervention. Once finalized, the investigators will conduct a pilot study with 60 adolescents aged 13-19 to assess user experience, acceptability and feasibility of the digital game.
详细描述
Formative Work: In year 1, the aim is to design and develop a digital game that models the process of a safety planning intervention. To do so, the investigators will explore and better understand peer or student perceptions around potential warning signs, coping strategies, and seeking help among youth who may be at greater risk of suicide due to misuse of substances. Focus groups with adolescents, college-aged youth, and school-based mental health providers will be conducted. Findings will inform the development of a digital intervention to reduce the risk of suicide among adolescents who misuse substances. Once a prototype of the game is developed, the investigators will conduct play-test focus groups with adolescents and school-based mental health providers to finalize the digital game.
The focus of this clinical trial is the Pilot RCT: In year 2, the investigators will assess user experience, acceptability, and feasibility of the game as well as explore the following proximal outcomes such as but not limited to adolescent well-being, intentions to use a safety planning intervention, coping strategies, substance misuse in last 30 days, and associated risk factors related to suicidal risk (e.g., hopelessness, impulsivity, etc.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •attend a high school that has a school-based behavioral health provider
- •be fluent in reading English during the consent/assent process
- •be willing to sit for a single session to complete pre-/post-assessments, engage with the game (~45min), and participate in a post-gameplay focus group (if in the experimental group) for 60min
- •provide assent and parental/guardian consent (if<age 18).
排除标准
- •Any student who is actively suicidal and/or moderately severe to severely depressed will be flagged and immediately connected to the school-based provider on site.
- •If a student indicates moderately severe to severe symptoms of depression, student will be flagged and immediately connected to the school-based provider for a risk assessment and will follow appropriate school protocols. If student is cleared by the school-based provider, student may continue in the study and the school -based provider will follow up with student in two weeks.
- •If a student screens positive for suicide (but is not acutely suicidal), student will be flagged and immediately connected to school-based provider for a risk assessment and will follow appropriate school protocols. If student is cleared by school-based provider, student may continue in study and the school-based provider will follow up with student in two weeks.
- •If student is acutely suicidal, student will be flagged and immediately connected to school-based provider who will follow school protocol (e.g., contact 211, contact parent/guardian, etc.). They will be ineligible to participate in the study on this day. Student may not return to rescreen for participation for at least 2 weeks and only when they are no longer actively suicidal.
- •Rescreening: Participants will not have to repeat the questions related to static variables (such as demographics and past experiences), but the baseline assessment of dynamic variables will need to be repeated and meet eligibility requirements.
结局指标
主要结局
Measuring Usability at Post-Gameplay
时间窗: Immediately after Gameplay, up to 30 minutes
Participants will complete surveys through a secured, data management system (RedCap). The Usefulness, Satisfaction, and Ease of Use Questionnaire (USE) is a validated, 30-item scale, where responses to system usability are measured on a scale from 1-7 where 1= strongly disagree and 7= strongly agree. Total score and subscales range 1-7. Higher scores indicate higher game usability.
Assessing the Digital Experience at Post-Gameplay
时间窗: Immediately after Gameplay, up to 30 minutes
Participants were asked about negative and positive aspects of the digital experience. Data presented here are the count of overall positive and negative statements taken from an open ended question asking participants to provide up to 3 positive and 3 negative aspects of the digital experience.
Measuring User Experience at Post-Gameplay
时间窗: Immediately after Gameplay, up to 30 minutes
Participants will complete surveys through a secured data management system (RedCap). The User Engagement Scale-Short Form (UES-Short Form) is a validated, 12-item self report measure that assesses six domains of engagement where responses are measured on a 5-point likert scale where 1= strongly disagree and 5= strongly agree. Total score range 1-5.Higher scores indicate higher user engagement.
Measuring Acceptability at Post-Gameplay
时间窗: Immediately after Gameplay, up to 30 minutes
Participants will complete surveys through a secured data management system (RedCap). The Acceptability of Intervention Measure (AIM) is a validated, 4-item self-report measure of perceived acceptability where responses are measured on a 5-point likert scale where 1 = completely disagree and 5= completely agree. Higher scores indicate higher intervention acceptability. Note: This measure was removed from the final questionnaire due to redundancy.
Measuring Feasibility at Post-Gameplay
时间窗: Immediately after Gameplay, up to 30 minutes
Feasibility will be measured through observation. Participants will also answer qualitative questions (e.g. does the intervention work? can the intervention be implemented in schools?) that will be developed by the study team. These questions are not a part of a larger scale. Minimal protocol deviations (Successful completion of protocols and procedures and minimal amendments through IRB) indicate feasibility of the digital game intervention. Data presented here are the number of deviations by type.
次要结局
- Change From Baseline in Intentions to Use a Safety Approach at Post-gameplay and 3-months.(Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months.)
- Change From Baseline in Knowledge About the Safety Planning Approach at Post-gameplay and 3-months.(Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months)
- Change From Baseline in Help-Seeking Behavior at Post-gameplay and 3-months.(Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months.)
- Mean Number of Days of Substance Misuse in the Past 30 Days(Baseline, and at 3-Months.)
- Change From Baseline in Coping Strategies on Brief COPE Scale at Post-gameplay and 3-months(Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months.)
- Change From Baseline in Mindfulness at Post Gameplay and 3-months(Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-months)
- Change From Baseline in Emotion Regulation at Post-gameplay and 3-months(Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-months)
- Percentage of Adolescents Thriving Post-gameplay and 3-months.(Immediately after Gameplay (up to 30 minutes), and at 3-Months.)
- Change From Baseline in Severity of Suicidal Thoughts and Associative Behaviors on Concise Health Risk Tracking Self-Report (CHRT-SR) at 3-months.(Baseline, and at 3-Months.)
- Change From Baseline in Anxiety at 3-months.(Baseline, and at 3-Months.)
- Change From Baseline in Depression at 3-months.(Baseline, and at 3-Months.)