N/A
N=60
A Digital Game Targeting Suicide Prevention in Adolescents Who Report Substance Misuse
Substance Misuse · Suicide
Bottom Line
View on ClinicalTrials.gov: NCT05517382 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Measuring Usability at Post-Gameplay — 2.73; 4.39; 4.58; 4.69 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- supportED (Other); Control (Other)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measuring Usability at Post-Gameplay |
2.73; 4.39; 4.58; 4.69; 5.07 | — |
| PRIMARY Assessing the Digital Experience at Post-Gameplay |
32; 27 | — |
| PRIMARY Measuring User Experience at Post-Gameplay |
2.73 | — |
| PRIMARY Measuring Acceptability at Post-Gameplay |
— | — |
| PRIMARY Measuring Feasibility at Post-Gameplay |
6; 2; 1 | — |
| SECONDARY Change From Baseline in Coping Strategies on Brief COPE Scale at Post-gameplay and 3-months |
60.72; 60.72; 58.92; 57.02; 63.36; 62.91 | — |
| SECONDARY Change From Baseline in Emotion Regulation at Post-gameplay and 3-months |
45.18; 45.18; 40.72; 42.84; 42.72; 45.58 | — |
| SECONDARY Percentage of Adolescents Thriving Post-gameplay and 3-months. |
41.9; 58.6; 51.6; 58.6; 58.1; 57.1 | 0.20 |
| SECONDARY Change From Baseline in Mindfulness at Post Gameplay and 3-months |
3.47; 3.47; 3.46; 3.37; 3.44; 3.28 | 0.1759 |
| SECONDARY Change From Baseline in Intentions to Use a Safety Approach at Post-gameplay and 3-months. |
15.78; 15.78; 17.84; 16.38; 16.65; 17.59 | — |
| SECONDARY Change From Baseline in Knowledge About the Safety Planning Approach at Post-gameplay and 3-months. |
6.32; 6.32; 6.3; 6.23; 6.27; 6.13 | — |
| SECONDARY Change From Baseline in Severity of Suicidal Thoughts and Associative Behaviors on Concise Health Risk Tracking Self-Report (CHRT-SR) at 3-months. |
9.33; 9.33; 8.26; 7.24 | — |
| SECONDARY Change From Baseline in Anxiety at 3-months. |
5.25; 5.25; 3.59; 4.41 | — |
| SECONDARY Change From Baseline in Depression at 3-months. |
5.25; 5.25; 3.96; 4.97 | — |
| SECONDARY Change From Baseline in Help-Seeking Behavior at Post-gameplay and 3-months. |
41.02; 41.02; 42.21; 42.53; 43.25; 42.57 | — |
| SECONDARY Mean Number of Days of Substance Misuse in the Past 30 Days |
0.0322581; 0.137931; 0; 0; 0; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05517382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.