Substance Misuse, Suicide
Conditions
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.).
Interventions
OTHERsupportED
suicide prevention videogame
OTHERControl
non-health related videogame
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Eligible individuals will be assigned to either the 1) supportED group (n=30) or 2) control group (n=30).
Eligibility
Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measuring Feasibility at Post-Gameplay | 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. |
| Measuring Usability at Post-Gameplay | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Participants will complete surveys through a secured, data management system (RedCap). Intentions to use a safety plan is a 7-item measure. Responses are measured on a 5-point likert scale where 1= strongly disagree and 5= strongly agree. Items are summed for a total score range of 7-35. Higher scores indicate increased intentions to use a safety planning approach. |
| 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 | Participants will complete surveys through a secured, data management system (RedCap). 6-items will assess learning goals of the intervention developed by the study team (e.g. warning signs, coping strategies, resources for support). These items are not apart of a larger scale. Total score range 0-8. Higher scores indicate increased knowledge about gameplay content. |
| 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. | Participants will complete surveys through a secured, data management system (RedCap). Concise Health Risk Tracking Self-Report (CHRT-SR) is a validated, 14 item, 5-point self report measures comprised of the following subscales: Propensity, Impulsivity, and Suicidal Thoughts. Responses are measured on a 5-point likert scale where 0= strongly disagree and 4= strongly agree. Total score range of 0-56. Higher scores indicate increased severity of suicidal thoughts and associative behaviors. |
| Change From Baseline in Depression at 3-months. | Baseline, and at 3-Months. | Participants will complete surveys through a secured, data management system (RedCap). The Patient Health Questionnaire-9 (PHQ-9) is a validated, 9-item self report measure that assesses symptoms of depression. The total score on the PHQ-9 ranges from 0 to 27. Higher scores indicate increased levels of depression. |
| 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. | Participants will complete surveys through a secured, data management system (RedCap). The General Help Seeking Questionnaire (GHSQ) is a validated, 20-item self-report measure that assesses professional and non professional help seeking behaviors. Responses are measured on a 7-point likert scale where 1=extremely unlikely and 7=extremely likely. Total score range 20-140. Higher scores indicate increased help-seeking behavior. |
| Mean Number of Days of Substance Misuse in the Past 30 Days | Baseline, and at 3-Months. | Participants will complete surveys through a secured, data management system (RedCap). Substance misuse of alcohol, tobacco and marijuana in the past 30-days will be measured. These measures are self-reported. Responses indicate frequency of use within past 30-days. |
| Change From Baseline in Anxiety at 3-months. | Baseline, and at 3-Months. | Participants will complete surveys through a secured, data management system (RedCap). The General Anxiety Disorder-7 (GAD-7) is a validated, 7-item self report measure that assesses symptoms of anxiety. Responses are measured on a 4-point likert scale where 0=not at all and 3=nearly everyday. Item scores are summed with a total score ranging from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety. Higher scores indicate increased levels of anxiety. |
| 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. | Participants will complete surveys through a secured, data management system (RedCap). Brief Coping Orientation to Problems Experienced (Brief-COPE) adaptive and maladaptive subscales are validated, 28- item, 4-point self-report measures. Brief COPE measures assess 14 conceptually different coping reactions. Responses are measured on a 4-point likert scale where 1= I haven't been doing this at all and 4= I've been doing this a lot. Scores are summed to achieve total score with a range of 28-112. Higher scores indicate increased utilization of coping strategies within and across domains. |
| Change From Baseline in Emotion Regulation at Post-gameplay and 3-months | Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-months | Participants will complete surveys through a secured, data management system (RedCap). State-Difficulties in Emotion Regulation (S-DERS) is a validated, 21-item self-report measure. Responses are measured on a 5-point likert scale where 1= almost never and 5= almost always. Scores are summed for total score range of 21-105. Higher scores suggest greater problems with emotion regulation. |
| Percentage of Adolescents Thriving Post-gameplay and 3-months. | Immediately after Gameplay (up to 30 minutes), and at 3-Months. | Participants will complete surveys through a secured, data management system (RedCap). The Adolescent Well-Being assessment is a validated, 15-item school-based, self-report measure with 11-items focused on well being, and 5-items focused on student demographics. Higher scores indicate increased adolescent well-being. Data presented here is the difference in the change in the percentage of participants who were rated as thriving based on scores. |
| Change From Baseline in Mindfulness at Post Gameplay and 3-months | Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-months | Participants will complete surveys through a secured, data management system (RedCap). The Five Facet Mindfulness Questionnaire (FFMQ) FFMQ is a validated, 15-item self-report measure that assesses facets of mindfulness. Responses are measured on a 5 point-likert scale where 1= never or very rarely true, and 5= very often or always true. Total score range 0-15. Higher scores indicate higher levels of mindfulness. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Suicide Risk at 3-months | Baseline, and at 3-Months. | The Ask Suicide Screen Questions (ASQ) is a validated 5-question screening tool to determine suicide risk. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| supportED Group Participants in this group will engage with the digital game for one session (\
45min) and will receive NIDA and NIMH pamphlets on substance misuse and mental health for youth at the end of the session. Participants will use a dedicated device (e.g., tablet, laptop, or desktop) to access their digital experience on the web. The research staff and a school-based provider will be present to monitor gameplay, to provide support, if needed, and to field questions in person.
supportED: suicide prevention videogame | 31 |
| Control Group Participants in this group will engage with a non-health-related game for one session (\
45min) and will receive NIDA and NIMH pamphlets on substance misuse and mental health for youth at the end of the session. Participants will use a dedicated device (e.g., tablet, laptop, or desktop) to access their digital experience on the web. The research staff and a school-based provider will be present to monitor gameplay, to provide support, if needed, and to field questions in person.
Control: non-health related videogame | 29 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | supportED Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 15.96 years STANDARD_DEVIATION 1.02 | 16.18 years STANDARD_DEVIATION 1.14 | 16.63 years STANDARD_DEVIATION 1.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 41 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 19 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race/Ethnicity, Customized Race More than one race | 4 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Unknown or Not Reported | 4 Participants | 9 Participants | 5 Participants |
| Race/Ethnicity, Customized Race White | 17 Participants | 29 Participants | 12 Participants |
| Region of Enrollment United States | 31 participants | 60 participants | 29 participants |
| Sex: Female, Male Female | 17 Participants | 34 Participants | 17 Participants |
| Sex: Female, Male Male | 14 Participants | 26 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 29 |
| other Total, other adverse events | 0 / 31 | 0 / 29 |
| serious Total, serious adverse events | 0 / 31 | 0 / 29 |
Outcome results
Primary
Assessing the Digital Experience at Post-Gameplay
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.
Time frame: Immediately after Gameplay, up to 30 minutes
Population: All coded statements provided in the open ended question. This outcome was not collected for the control arm.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| supportED Group | Assessing the Digital Experience at Post-Gameplay | Negative | 27 statements |
| supportED Group | Assessing the Digital Experience at Post-Gameplay | Positive | 32 statements |
Primary
Measuring Acceptability at Post-Gameplay
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.
Time frame: Immediately after Gameplay, up to 30 minutes
Population: Survey was redundant and therefore removed. This data was not collected.
Primary
Measuring Feasibility at Post-Gameplay
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.
Time frame: Immediately after Gameplay, up to 30 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| supportED Group | Measuring Feasibility at Post-Gameplay | RedCap Malfunction | 6 deviations |
| supportED Group | Measuring Feasibility at Post-Gameplay | Incomplete assent form signed off on | 2 deviations |
| supportED Group | Measuring Feasibility at Post-Gameplay | 3-month form (first 3 measures) were completed at baseline. | 1 deviations |
Primary
Measuring Usability at Post-Gameplay
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.
Time frame: Immediately after Gameplay, up to 30 minutes
Population: This outcome was not collected for the control arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| supportED Group | Measuring Usability at Post-Gameplay | Ease of use | 4.58 score on a scale | Standard Deviation 1.5 |
| supportED Group | Measuring Usability at Post-Gameplay | Satisfaction | 4.69 score on a scale | Standard Deviation 1.76 |
| supportED Group | Measuring Usability at Post-Gameplay | Ease of learning | 5.07 score on a scale | Standard Deviation 1.76 |
| supportED Group | Measuring Usability at Post-Gameplay | Total score mean | 2.73 score on a scale | Standard Deviation 0.52 |
| supportED Group | Measuring Usability at Post-Gameplay | Usefulness | 4.39 score on a scale | Standard Deviation 1.7 |
Primary
Measuring User Experience at Post-Gameplay
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.
Time frame: Immediately after Gameplay, up to 30 minutes
Population: This outcome was not collected for the control arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| supportED Group | Measuring User Experience at Post-Gameplay | 2.73 score on a scale | Standard Deviation 0.52 |
Secondary
Change From Baseline in Anxiety at 3-months.
Participants will complete surveys through a secured, data management system (RedCap). The General Anxiety Disorder-7 (GAD-7) is a validated, 7-item self report measure that assesses symptoms of anxiety. Responses are measured on a 4-point likert scale where 0=not at all and 3=nearly everyday. Item scores are summed with a total score ranging from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety. Higher scores indicate increased levels of anxiety.
Time frame: Baseline, and at 3-Months.
Population: one participant did not complete 3 month follow up
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| supportED Group | Change From Baseline in Anxiety at 3-months. | Baseline | 5.25 score on a scale |
| supportED Group | Change From Baseline in Anxiety at 3-months. | 3 month | 3.59 score on a scale |
| Control Group | Change From Baseline in Anxiety at 3-months. | 3 month | 4.41 score on a scale |
| Control Group | Change From Baseline in Anxiety at 3-months. | Baseline | 5.25 score on a scale |
Secondary
Change From Baseline in Coping Strategies on Brief COPE Scale at Post-gameplay and 3-months
Participants will complete surveys through a secured, data management system (RedCap). Brief Coping Orientation to Problems Experienced (Brief-COPE) adaptive and maladaptive subscales are validated, 28- item, 4-point self-report measures. Brief COPE measures assess 14 conceptually different coping reactions. Responses are measured on a 4-point likert scale where 1= I haven't been doing this at all and 4= I've been doing this a lot. Scores are summed to achieve total score with a range of 28-112. Higher scores indicate increased utilization of coping strategies within and across domains.
Time frame: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months.
Population: one participant did not complete 3 month follow up
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| supportED Group | Change From Baseline in Coping Strategies on Brief COPE Scale at Post-gameplay and 3-months | Post gameplay | 58.92 score on a scale |
| supportED Group | Change From Baseline in Coping Strategies on Brief COPE Scale at Post-gameplay and 3-months | 3 months | 63.36 score on a scale |
| supportED Group | Change From Baseline in Coping Strategies on Brief COPE Scale at Post-gameplay and 3-months | Baseline | 60.72 score on a scale |
| Control Group | Change From Baseline in Coping Strategies on Brief COPE Scale at Post-gameplay and 3-months | Baseline | 60.72 score on a scale |
| Control Group | Change From Baseline in Coping Strategies on Brief COPE Scale at Post-gameplay and 3-months | Post gameplay | 57.02 score on a scale |
| Control Group | Change From Baseline in Coping Strategies on Brief COPE Scale at Post-gameplay and 3-months | 3 months | 62.91 score on a scale |
Secondary
Change From Baseline in Depression at 3-months.
Participants will complete surveys through a secured, data management system (RedCap). The Patient Health Questionnaire-9 (PHQ-9) is a validated, 9-item self report measure that assesses symptoms of depression. The total score on the PHQ-9 ranges from 0 to 27. Higher scores indicate increased levels of depression.
Time frame: Baseline, and at 3-Months.
Population: one participant did not complete 3 month follow up
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| supportED Group | Change From Baseline in Depression at 3-months. | Baseline | 5.25 score on a scale |
| supportED Group | Change From Baseline in Depression at 3-months. | 3 month | 3.96 score on a scale |
| Control Group | Change From Baseline in Depression at 3-months. | Baseline | 5.25 score on a scale |
| Control Group | Change From Baseline in Depression at 3-months. | 3 month | 4.97 score on a scale |
Secondary
Change From Baseline in Emotion Regulation at Post-gameplay and 3-months
Participants will complete surveys through a secured, data management system (RedCap). State-Difficulties in Emotion Regulation (S-DERS) is a validated, 21-item self-report measure. Responses are measured on a 5-point likert scale where 1= almost never and 5= almost always. Scores are summed for total score range of 21-105. Higher scores suggest greater problems with emotion regulation.
Time frame: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-months
Population: one participant did not complete 3 month follow up
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| supportED Group | Change From Baseline in Emotion Regulation at Post-gameplay and 3-months | Post gameplay | 40.72 score on a scale |
| supportED Group | Change From Baseline in Emotion Regulation at Post-gameplay and 3-months | 3 months | 42.72 score on a scale |
| supportED Group | Change From Baseline in Emotion Regulation at Post-gameplay and 3-months | Baseline | 45.18 score on a scale |
| Control Group | Change From Baseline in Emotion Regulation at Post-gameplay and 3-months | Baseline | 45.18 score on a scale |
| Control Group | Change From Baseline in Emotion Regulation at Post-gameplay and 3-months | Post gameplay | 42.84 score on a scale |
| Control Group | Change From Baseline in Emotion Regulation at Post-gameplay and 3-months | 3 months | 45.58 score on a scale |
Secondary
Change From Baseline in Help-Seeking Behavior at Post-gameplay and 3-months.
Participants will complete surveys through a secured, data management system (RedCap). The General Help Seeking Questionnaire (GHSQ) is a validated, 20-item self-report measure that assesses professional and non professional help seeking behaviors. Responses are measured on a 7-point likert scale where 1=extremely unlikely and 7=extremely likely. Total score range 20-140. Higher scores indicate increased help-seeking behavior.
Time frame: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months.
Population: one participant did not complete 3 month follow up
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| supportED Group | Change From Baseline in Help-Seeking Behavior at Post-gameplay and 3-months. | Baseline | 41.02 score on a scale |
| supportED Group | Change From Baseline in Help-Seeking Behavior at Post-gameplay and 3-months. | Post gameplay | 42.21 score on a scale |
| supportED Group | Change From Baseline in Help-Seeking Behavior at Post-gameplay and 3-months. | 3 month | 43.25 score on a scale |
| Control Group | Change From Baseline in Help-Seeking Behavior at Post-gameplay and 3-months. | Baseline | 41.02 score on a scale |
| Control Group | Change From Baseline in Help-Seeking Behavior at Post-gameplay and 3-months. | Post gameplay | 42.53 score on a scale |
| Control Group | Change From Baseline in Help-Seeking Behavior at Post-gameplay and 3-months. | 3 month | 42.57 score on a scale |
Secondary
Change From Baseline in Intentions to Use a Safety Approach at Post-gameplay and 3-months.
Participants will complete surveys through a secured, data management system (RedCap). Intentions to use a safety plan is a 7-item measure. Responses are measured on a 5-point likert scale where 1= strongly disagree and 5= strongly agree. Items are summed for a total score range of 7-35. Higher scores indicate increased intentions to use a safety planning approach.
Time frame: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months.
Population: one participant did not complete 3 month follow up
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| supportED Group | Change From Baseline in Intentions to Use a Safety Approach at Post-gameplay and 3-months. | Post gameplay | 17.84 score on a scale |
| supportED Group | Change From Baseline in Intentions to Use a Safety Approach at Post-gameplay and 3-months. | 3 months | 16.65 score on a scale |
| supportED Group | Change From Baseline in Intentions to Use a Safety Approach at Post-gameplay and 3-months. | Baseline | 15.78 score on a scale |
| Control Group | Change From Baseline in Intentions to Use a Safety Approach at Post-gameplay and 3-months. | Post gameplay | 16.38 score on a scale |
| Control Group | Change From Baseline in Intentions to Use a Safety Approach at Post-gameplay and 3-months. | Baseline | 15.78 score on a scale |
| Control Group | Change From Baseline in Intentions to Use a Safety Approach at Post-gameplay and 3-months. | 3 months | 17.59 score on a scale |
Secondary
Change From Baseline in Knowledge About the Safety Planning Approach at Post-gameplay and 3-months.
Participants will complete surveys through a secured, data management system (RedCap). 6-items will assess learning goals of the intervention developed by the study team (e.g. warning signs, coping strategies, resources for support). These items are not apart of a larger scale. Total score range 0-8. Higher scores indicate increased knowledge about gameplay content.
Time frame: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months
Population: one participant did not complete 3 month follow up
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| supportED Group | Change From Baseline in Knowledge About the Safety Planning Approach at Post-gameplay and 3-months. | Post gameplay | 6.3 score on a scale |
| supportED Group | Change From Baseline in Knowledge About the Safety Planning Approach at Post-gameplay and 3-months. | 3 months | 6.27 score on a scale |
| supportED Group | Change From Baseline in Knowledge About the Safety Planning Approach at Post-gameplay and 3-months. | Baseline | 6.32 score on a scale |
| Control Group | Change From Baseline in Knowledge About the Safety Planning Approach at Post-gameplay and 3-months. | Baseline | 6.32 score on a scale |
| Control Group | Change From Baseline in Knowledge About the Safety Planning Approach at Post-gameplay and 3-months. | Post gameplay | 6.23 score on a scale |
| Control Group | Change From Baseline in Knowledge About the Safety Planning Approach at Post-gameplay and 3-months. | 3 months | 6.13 score on a scale |
Secondary
Change From Baseline in Mindfulness at Post Gameplay and 3-months
Participants will complete surveys through a secured, data management system (RedCap). The Five Facet Mindfulness Questionnaire (FFMQ) FFMQ is a validated, 15-item self-report measure that assesses facets of mindfulness. Responses are measured on a 5 point-likert scale where 1= never or very rarely true, and 5= very often or always true. Total score range 0-15. Higher scores indicate higher levels of mindfulness.
Time frame: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-months
Population: one participant did not complete 3 month follow up
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| supportED Group | Change From Baseline in Mindfulness at Post Gameplay and 3-months | Post gameplay | 3.46 score on a scale |
| supportED Group | Change From Baseline in Mindfulness at Post Gameplay and 3-months | 3 months | 3.44 score on a scale |
| supportED Group | Change From Baseline in Mindfulness at Post Gameplay and 3-months | Baseline | 3.47 score on a scale |
| Control Group | Change From Baseline in Mindfulness at Post Gameplay and 3-months | Baseline | 3.47 score on a scale |
| Control Group | Change From Baseline in Mindfulness at Post Gameplay and 3-months | Post gameplay | 3.37 score on a scale |
| Control Group | Change From Baseline in Mindfulness at Post Gameplay and 3-months | 3 months | 3.28 score on a scale |
Comparison: At post game.p-value: 0.175995% CI: [-0.23, 0.04]Mixed Models Analysis
Comparison: At 3 monthp-value: 0.085795% CI: [-0.35, 0.02]Mixed Models Analysis
Secondary
Change From Baseline in Severity of Suicidal Thoughts and Associative Behaviors on Concise Health Risk Tracking Self-Report (CHRT-SR) at 3-months.
Participants will complete surveys through a secured, data management system (RedCap). Concise Health Risk Tracking Self-Report (CHRT-SR) is a validated, 14 item, 5-point self report measures comprised of the following subscales: Propensity, Impulsivity, and Suicidal Thoughts. Responses are measured on a 5-point likert scale where 0= strongly disagree and 4= strongly agree. Total score range of 0-56. Higher scores indicate increased severity of suicidal thoughts and associative behaviors.
Time frame: Baseline, and at 3-Months.
Population: one participant did not complete 3 month follow up
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| supportED Group | Change From Baseline in Severity of Suicidal Thoughts and Associative Behaviors on Concise Health Risk Tracking Self-Report (CHRT-SR) at 3-months. | Baseline | 9.33 score on a scale |
| supportED Group | Change From Baseline in Severity of Suicidal Thoughts and Associative Behaviors on Concise Health Risk Tracking Self-Report (CHRT-SR) at 3-months. | 3 months | 8.26 score on a scale |
| Control Group | Change From Baseline in Severity of Suicidal Thoughts and Associative Behaviors on Concise Health Risk Tracking Self-Report (CHRT-SR) at 3-months. | Baseline | 9.33 score on a scale |
| Control Group | Change From Baseline in Severity of Suicidal Thoughts and Associative Behaviors on Concise Health Risk Tracking Self-Report (CHRT-SR) at 3-months. | 3 months | 7.24 score on a scale |
Secondary
Mean Number of Days of Substance Misuse in the Past 30 Days
Participants will complete surveys through a secured, data management system (RedCap). Substance misuse of alcohol, tobacco and marijuana in the past 30-days will be measured. These measures are self-reported. Responses indicate frequency of use within past 30-days.
Time frame: Baseline, and at 3-Months.
Population: One participant did not complete 3 month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| supportED Group | Mean Number of Days of Substance Misuse in the Past 30 Days | Baseline-Alcohol | 0.0322581 days | Standard Deviation 0.1796053 |
| supportED Group | Mean Number of Days of Substance Misuse in the Past 30 Days | 3 months-Alcohol | 0 days | Standard Deviation 0 |
| supportED Group | Mean Number of Days of Substance Misuse in the Past 30 Days | Baseline-Tobacco | 0 days | Standard Deviation 0 |
| supportED Group | Mean Number of Days of Substance Misuse in the Past 30 Days | 3 month-Tobacco | 0 days | Standard Deviation 0 |
| supportED Group | Mean Number of Days of Substance Misuse in the Past 30 Days | Baseline-Marijuana | 0 days | Standard Deviation 0 |
| supportED Group | Mean Number of Days of Substance Misuse in the Past 30 Days | 3 month-Marijuana | 0 days | Standard Deviation 0 |
| Control Group | Mean Number of Days of Substance Misuse in the Past 30 Days | Baseline-Marijuana | 0 days | Standard Deviation 0 |
| Control Group | Mean Number of Days of Substance Misuse in the Past 30 Days | Baseline-Alcohol | 0.137931 days | Standard Deviation 0.5157614 |
| Control Group | Mean Number of Days of Substance Misuse in the Past 30 Days | 3 month-Tobacco | 0 days | Standard Deviation 0 |
| Control Group | Mean Number of Days of Substance Misuse in the Past 30 Days | 3 months-Alcohol | 0 days | Standard Deviation 0 |
| Control Group | Mean Number of Days of Substance Misuse in the Past 30 Days | 3 month-Marijuana | 0 days | Standard Deviation 0 |
| Control Group | Mean Number of Days of Substance Misuse in the Past 30 Days | Baseline-Tobacco | 0 days | Standard Deviation 0 |
Secondary
Percentage of Adolescents Thriving Post-gameplay and 3-months.
Participants will complete surveys through a secured, data management system (RedCap). The Adolescent Well-Being assessment is a validated, 15-item school-based, self-report measure with 11-items focused on well being, and 5-items focused on student demographics. Higher scores indicate increased adolescent well-being. Data presented here is the difference in the change in the percentage of participants who were rated as thriving based on scores.
Time frame: Immediately after Gameplay (up to 30 minutes), and at 3-Months.
Population: one participant did not complete 3 month follow up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| supportED Group | Percentage of Adolescents Thriving Post-gameplay and 3-months. | Baseline | 41.9 percentage of participants |
| supportED Group | Percentage of Adolescents Thriving Post-gameplay and 3-months. | Post game | 51.6 percentage of participants |
| supportED Group | Percentage of Adolescents Thriving Post-gameplay and 3-months. | 3 month | 58.1 percentage of participants |
| Control Group | Percentage of Adolescents Thriving Post-gameplay and 3-months. | Baseline | 58.6 percentage of participants |
| Control Group | Percentage of Adolescents Thriving Post-gameplay and 3-months. | Post game | 58.6 percentage of participants |
| Control Group | Percentage of Adolescents Thriving Post-gameplay and 3-months. | 3 month | 57.1 percentage of participants |
Comparison: At baselinep-value: 0.2t-test, 2 sided
Comparison: At Post gamep-value: 0.59t-test, 2 sided
Comparison: At 3 monthp-value: 0.94t-test, 2 sided
p-value: 0.55GEE
Other Pre-specified
Change From Baseline in Suicide Risk at 3-months
The Ask Suicide Screen Questions (ASQ) is a validated 5-question screening tool to determine suicide risk.
Time frame: Baseline, and at 3-Months.