Trial Outcomes & Findings for A Digital Game Targeting Suicide Prevention in Adolescents Who Report Substance Misuse (NCT NCT05517382)

NCT ID: NCT05517382

Last Updated: 2024-04-10

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 61 participants
• Primary outcome timeframe: Immediately after Gameplay, up to 30 minutes
• Results posted on: 2024-04-10

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	31	29
Overall Study Completed Baseline Measures	31	29
Overall Study Completed 3 Month Follow up	31	28
Overall Study COMPLETED	31	28
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	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	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
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

A Digital Game Targeting Suicide Prevention in Adolescents Who Report Substance Misuse

Baseline characteristics by cohort

Measure	supportED Group n=31 Participants 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	Control Group n=29 Participants 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	Total n=60 Participants Total of all reporting groups
Age, Continuous	15.96 years STANDARD_DEVIATION 1.02 • n=5 Participants	16.63 years STANDARD_DEVIATION 1.25 • n=7 Participants	16.18 years STANDARD_DEVIATION 1.14 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized Race · More than one race	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown or Not Reported	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	29 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately after Gameplay, up to 30 minutes

Population: This outcome was not collected for the control arm.

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.

Outcome measures

Measure	supportED Group n=31 Participants 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	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
Measuring Usability at Post-Gameplay Total score mean	2.73 score on a scale Standard Deviation 0.52	—
Measuring Usability at Post-Gameplay Usefulness	4.39 score on a scale Standard Deviation 1.70	—
Measuring Usability at Post-Gameplay Ease of use	4.58 score on a scale Standard Deviation 1.50	—
Measuring Usability at Post-Gameplay Satisfaction	4.69 score on a scale Standard Deviation 1.76	—
Measuring Usability at Post-Gameplay Ease of learning	5.07 score on a scale Standard Deviation 1.76	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	supportED Group n=59 statements 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	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
Assessing the Digital Experience at Post-Gameplay Positive	32 statements	—
Assessing the Digital Experience at Post-Gameplay Negative	27 statements	—

PRIMARY outcome

Timeframe: Immediately after Gameplay, up to 30 minutes

Population: This outcome was not collected for the control arm.

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.

Outcome measures

Measure	supportED Group n=31 Participants 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	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
Measuring User Experience at Post-Gameplay	2.73 score on a scale Standard Deviation 0.52	—

PRIMARY outcome

Timeframe: Immediately after Gameplay, up to 30 minutes

Population: Survey was redundant and therefore removed. This data was not collected.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	supportED Group n=31 Participants 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	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
Measuring Feasibility at Post-Gameplay RedCap Malfunction	6 deviations	—
Measuring Feasibility at Post-Gameplay Incomplete assent form signed off on	2 deviations	—
Measuring Feasibility at Post-Gameplay 3-month form (first 3 measures) were completed at baseline.	1 deviations	—

SECONDARY outcome

Timeframe: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months.

Population: one participant did not complete 3 month follow up

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.

Outcome measures

Measure	supportED Group n=31 Participants 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	Control Group n=29 Participants 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
Change From Baseline in Coping Strategies on Brief COPE Scale at Post-gameplay and 3-months Baseline	60.72 score on a scale Interval 57.26 to 64.17	60.72 score on a scale Interval 57.26 to 64.17
Change From Baseline in Coping Strategies on Brief COPE Scale at Post-gameplay and 3-months Post gameplay	58.92 score on a scale Interval 55.19 to 62.64	57.02 score on a scale Interval 53.25 to 60.79
Change From Baseline in Coping Strategies on Brief COPE Scale at Post-gameplay and 3-months 3 months	63.36 score on a scale Interval 59.23 to 67.49	62.91 score on a scale Interval 58.48 to 67.34

SECONDARY outcome

Timeframe: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-months

Population: one participant did not complete 3 month follow up

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.

Outcome measures

Measure	supportED Group n=31 Participants 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	Control Group n=29 Participants 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
Change From Baseline in Emotion Regulation at Post-gameplay and 3-months Baseline	45.18 score on a scale Interval 42.34 to 48.02	45.18 score on a scale Interval 42.34 to 48.02
Change From Baseline in Emotion Regulation at Post-gameplay and 3-months Post gameplay	40.72 score on a scale Interval 37.95 to 43.5	42.84 score on a scale Interval 39.99 to 45.69
Change From Baseline in Emotion Regulation at Post-gameplay and 3-months 3 months	42.72 score on a scale Interval 39.35 to 46.1	45.58 score on a scale Interval 42.08 to 49.08

SECONDARY outcome

Timeframe: Immediately after Gameplay (up to 30 minutes), and at 3-Months.

Population: one participant did not complete 3 month follow up

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.

Outcome measures

Measure	supportED Group n=31 Participants 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	Control Group n=29 Participants 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
Percentage of Adolescents Thriving Post-gameplay and 3-months. Baseline	41.9 percentage of participants	58.6 percentage of participants
Percentage of Adolescents Thriving Post-gameplay and 3-months. Post game	51.6 percentage of participants	58.6 percentage of participants
Percentage of Adolescents Thriving Post-gameplay and 3-months. 3 month	58.1 percentage of participants	57.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-months

Population: one participant did not complete 3 month follow up

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.

Outcome measures

Measure	supportED Group n=31 Participants 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	Control Group n=29 Participants 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
Change From Baseline in Mindfulness at Post Gameplay and 3-months Baseline	3.47 score on a scale Interval 3.35 to 3.59	3.47 score on a scale Interval 3.35 to 3.59
Change From Baseline in Mindfulness at Post Gameplay and 3-months Post gameplay	3.46 score on a scale Interval 3.32 to 3.59	3.37 score on a scale Interval 3.23 to 3.5
Change From Baseline in Mindfulness at Post Gameplay and 3-months 3 months	3.44 score on a scale Interval 3.29 to 3.59	3.28 score on a scale Interval 3.13 to 3.43

SECONDARY outcome

Timeframe: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months.

Population: one participant did not complete 3 month follow up

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.

Outcome measures

Measure	supportED Group n=31 Participants 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	Control Group n=29 Participants 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
Change From Baseline in Intentions to Use a Safety Approach at Post-gameplay and 3-months. Baseline	15.78 score on a scale Interval 14.33 to 17.24	15.78 score on a scale Interval 14.33 to 17.24
Change From Baseline in Intentions to Use a Safety Approach at Post-gameplay and 3-months. Post gameplay	17.84 score on a scale Interval 16.12 to 19.55	16.38 score on a scale Interval 14.63 to 18.13
Change From Baseline in Intentions to Use a Safety Approach at Post-gameplay and 3-months. 3 months	16.65 score on a scale Interval 13.99 to 19.31	17.59 score on a scale Interval 14.81 to 20.38

SECONDARY outcome

Timeframe: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months

Population: one participant did not complete 3 month follow up

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.

Outcome measures

Measure	supportED Group n=31 Participants 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	Control Group n=29 Participants 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
Change From Baseline in Knowledge About the Safety Planning Approach at Post-gameplay and 3-months. Baseline	6.32 score on a scale Interval 5.92 to 6.71	6.32 score on a scale Interval 5.92 to 6.71
Change From Baseline in Knowledge About the Safety Planning Approach at Post-gameplay and 3-months. Post gameplay	6.3 score on a scale Interval 5.78 to 6.82	6.23 score on a scale Interval 5.7 to 6.76
Change From Baseline in Knowledge About the Safety Planning Approach at Post-gameplay and 3-months. 3 months	6.27 score on a scale Interval 5.74 to 6.81	6.13 score on a scale Interval 5.58 to 6.68

SECONDARY outcome

Timeframe: Baseline, and at 3-Months.

Population: one participant did not complete 3 month follow up

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.

Outcome measures

Measure	supportED Group n=31 Participants 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	Control Group n=29 Participants 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
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 Interval 7.23 to 11.43	9.33 score on a scale Interval 7.23 to 11.43
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 Interval 5.61 to 10.91	7.24 score on a scale Interval 4.44 to 10.04

SECONDARY outcome

Timeframe: Baseline, and at 3-Months.

Population: one participant did not complete 3 month follow up

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.

Outcome measures

Measure	supportED Group n=31 Participants 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	Control Group n=29 Participants 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
Change From Baseline in Anxiety at 3-months. Baseline	5.25 score on a scale Interval 3.84 to 6.66	5.25 score on a scale Interval 3.84 to 6.66
Change From Baseline in Anxiety at 3-months. 3 month	3.59 score on a scale Interval 2.1 to 5.08	4.41 score on a scale Interval 2.84 to 5.99

SECONDARY outcome

Timeframe: Baseline, and at 3-Months.

Population: one participant did not complete 3 month follow up

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.

Outcome measures

Measure	supportED Group n=31 Participants 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	Control Group n=29 Participants 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
Change From Baseline in Depression at 3-months. Baseline	5.25 score on a scale Interval 3.87 to 6.63	5.25 score on a scale Interval 3.87 to 6.63
Change From Baseline in Depression at 3-months. 3 month	3.96 score on a scale Interval 2.36 to 5.56	4.97 score on a scale Interval 3.29 to 6.65

SECONDARY outcome

Timeframe: Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months.

Population: one participant did not complete 3 month follow up

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.

Outcome measures

Measure	supportED Group n=31 Participants 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	Control Group n=29 Participants 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
Change From Baseline in Help-Seeking Behavior at Post-gameplay and 3-months. Baseline	41.02 score on a scale Interval 38.16 to 43.87	41.02 score on a scale Interval 38.16 to 43.87
Change From Baseline in Help-Seeking Behavior at Post-gameplay and 3-months. Post gameplay	42.21 score on a scale Interval 39.2 to 45.22	42.53 score on a scale Interval 39.49 to 45.58
Change From Baseline in Help-Seeking Behavior at Post-gameplay and 3-months. 3 month	43.25 score on a scale Interval 39.79 to 46.71	42.57 score on a scale Interval 38.97 to 46.18

SECONDARY outcome

Timeframe: Baseline, and at 3-Months.

Population: One participant did not complete 3 month follow up

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.

Outcome measures

Measure	supportED Group n=31 Participants 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	Control Group n=29 Participants 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
Mean Number of Days of Substance Misuse in the Past 30 Days Baseline-Alcohol	0.0322581 days Standard Deviation 0.1796053	0.137931 days Standard Deviation 0.5157614
Mean Number of Days of Substance Misuse in the Past 30 Days 3 months-Alcohol	0 days Standard Deviation 0	0 days Standard Deviation 0
Mean Number of Days of Substance Misuse in the Past 30 Days Baseline-Tobacco	0 days Standard Deviation 0	0 days Standard Deviation 0
Mean Number of Days of Substance Misuse in the Past 30 Days 3 month-Tobacco	0 days Standard Deviation 0	0 days Standard Deviation 0
Mean Number of Days of Substance Misuse in the Past 30 Days Baseline-Marijuana	0 days Standard Deviation 0	0 days Standard Deviation 0
Mean Number of Days of Substance Misuse in the Past 30 Days 3 month-Marijuana	0 days Standard Deviation 0	0 days Standard Deviation 0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, and at 3-Months.

The Ask Suicide Screen Questions (ASQ) is a validated 5-question screening tool to determine suicide risk.

Outcome measures

Outcome data not reported

Adverse Events

supportED Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Claudia-Santi Fernandes

Yale University

Phone: 203-785-2885

Email: Claudiasanti.fernandes@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place