Clinical trial NCT05517382: A Digital Game Targeting Suicide Prevention in Adolescents Who Report Substance Misuse
Official title: A Digital Game Targeting Suicide Prevention in Adolescents Who Report Substance Misuse (Formative Work and Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Misuse
Suicide
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-08-26
Enrollment: 61
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible individuals will be assigned to either the 1) supportED group (n=30) or 2) control group (n=30).
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.).

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Measuring Usability at Post-Gameplay
timeFrame: Immediately after Gameplay, up to 30 minutes
measure: Assessing the Digital Experience at Post-Gameplay
timeFrame: Immediately after Gameplay, up to 30 minutes
measure: Measuring User Experience at Post-Gameplay
timeFrame: Immediately after Gameplay, up to 30 minutes
measure: Measuring Acceptability at Post-Gameplay
timeFrame: Immediately after Gameplay, up to 30 minutes
measure: Measuring Feasibility at Post-Gameplay
timeFrame: Immediately after Gameplay, up to 30 minutes
Secondary outcomes:
measure: Change From Baseline in Coping Strategies on Brief COPE Scale at Post-gameplay and 3-months
timeFrame: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months.
measure: Change From Baseline in Emotion Regulation at Post-gameplay and 3-months
timeFrame: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-months
measure: Percentage of Adolescents Thriving Post-gameplay and 3-months.
timeFrame: Immediately after Gameplay (up to 30 minutes), and at 3-Months.
measure: Change From Baseline in Mindfulness at Post Gameplay and 3-months
timeFrame: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-months
measure: Change From Baseline in Intentions to Use a Safety Approach at Post-gameplay and 3-months.
timeFrame: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months.
measure: Change From Baseline in Knowledge About the Safety Planning Approach at Post-gameplay and 3-months.
timeFrame: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months
measure: Change From Baseline in Severity of Suicidal Thoughts and Associative Behaviors on Concise Health Risk Tracking Self-Report (CHRT-SR) at 3-months.
timeFrame: Baseline, and at 3-Months.
measure: Change From Baseline in Anxiety at 3-months.
timeFrame: Baseline, and at 3-Months.
measure: Change From Baseline in Depression at 3-months.
timeFrame: Baseline, and at 3-Months.
measure: Change From Baseline in Help-Seeking Behavior at Post-gameplay and 3-months.
timeFrame: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months.
measure: Mean Number of Days of Substance Misuse in the Past 30 Days
timeFrame: Baseline, and at 3-Months.
Other outcomes:
measure: Change From Baseline in Suicide Risk at 3-months
timeFrame: Baseline, and at 3-Months.
Locations:
city: New Haven
country: United States
facility: Yale
state: Connecticut
Study officials:
affiliation: Yale University
name: Claudia-Santi F Fernandes, Ed.D., LPC
role: PRINCIPAL_INVESTIGATOR
References: