An interventional study of supportED and Control in Substance Misuse and Suicide, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 13 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by Yale University · Not applicable, Interventional, and Prevention
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.
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.).
701 studies on the registry are indexed under Suicide; 183 are open to participants now.
This study's enrollment of 61 is below the median of 104 across 560 interventional studies indexed under Suicide.
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Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
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Exclusion Criteria:
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.
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.
Other: supportED
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.
Other: Control
suicide prevention videogame
non-health related videogame
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
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
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
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
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
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.
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
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.
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
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.
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
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.
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.
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.
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.
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.
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.
| Milestone | supportED Group | Control Group |
|---|---|---|
| Started | 31 | 29 |
| Completed baseline measures | 31 | 29 |
| Completed 3 month follow up | 31 | 28 |
| Completed | 31 | 28 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
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.
| score on a scale | supportED Group |
|---|---|
| Total score mean | 2.73 ± 0.52 |
| Usefulness | 4.39 ± 1.70 |
| Ease of use | 4.58 ± 1.50 |
| Satisfaction | 4.69 ± 1.76 |
| Ease of learning | 5.07 ± 1.76 |
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.
| statements | supportED Group |
|---|---|
| Positive | 32 |
| Negative | 27 |
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.
| score on a scale | supportED Group |
|---|---|
| Measuring User Experience at Post-Gameplay | 2.73 ± 0.52 |
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.
No measurements were reported for this outcome.
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.
| deviations | supportED Group |
|---|---|
| RedCap Malfunction | 6 |
| Incomplete assent form signed off on | 2 |
| 3-month form (first 3 measures) were completed at baseline. | 1 |
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.
| score on a scale | supportED Group | Control Group |
|---|---|---|
| Baseline | 60.72 (57.26 to 64.17) | 60.72 (57.26 to 64.17) |
| Post gameplay | 58.92 (55.19 to 62.64) | 57.02 (53.25 to 60.79) |
| 3 months | 63.36 (59.23 to 67.49) | 62.91 (58.48 to 67.34) |
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.
| score on a scale | supportED Group | Control Group |
|---|---|---|
| Baseline | 45.18 (42.34 to 48.02) | 45.18 (42.34 to 48.02) |
| Post gameplay | 40.72 (37.95 to 43.50) | 42.84 (39.99 to 45.69) |
| 3 months | 42.72 (39.35 to 46.10) | 45.58 (42.08 to 49.08) |
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.
| percentage of participants | supportED Group | Control Group |
|---|---|---|
| Baseline | 41.9 | 58.6 |
| Post game | 51.6 | 58.6 |
| 3 month | 58.1 | 57.1 |
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.
| score on a scale | supportED Group | Control Group |
|---|---|---|
| Baseline | 3.47 (3.35 to 3.59) | 3.47 (3.35 to 3.59) |
| Post gameplay | 3.46 (3.32 to 3.59) | 3.37 (3.23 to 3.50) |
| 3 months | 3.44 (3.29 to 3.59) | 3.28 (3.13 to 3.43) |
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.
| score on a scale | supportED Group | Control Group |
|---|---|---|
| Baseline | 15.78 (14.33 to 17.24) | 15.78 (14.33 to 17.24) |
| Post gameplay | 17.84 (16.12 to 19.55) | 16.38 (14.63 to 18.13) |
| 3 months | 16.65 (13.99 to 19.31) | 17.59 (14.81 to 20.38) |
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.
| score on a scale | supportED Group | Control Group |
|---|---|---|
| Baseline | 6.32 (5.92 to 6.71) | 6.32 (5.92 to 6.71) |
| Post gameplay | 6.3 (5.78 to 6.82) | 6.23 (5.7 to 6.76) |
| 3 months | 6.27 (5.74 to 6.81) | 6.13 (5.58 to 6.68) |
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.
| score on a scale | supportED Group | Control Group |
|---|---|---|
| Baseline | 9.33 (7.23 to 11.43) | 9.33 (7.23 to 11.43) |
| 3 months | 8.26 (5.61 to 10.91) | 7.24 (4.44 to 10.04) |
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.
| score on a scale | supportED Group | Control Group |
|---|---|---|
| Baseline | 5.25 (3.84 to 6.66) | 5.25 (3.84 to 6.66) |
| 3 month | 3.59 (2.10 to 5.08) | 4.41 (2.84 to 5.99) |
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.
| score on a scale | supportED Group | Control Group |
|---|---|---|
| Baseline | 5.25 (3.87 to 6.63) | 5.25 (3.87 to 6.63) |
| 3 month | 3.96 (2.36 to 5.56) | 4.97 (3.29 to 6.65) |
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.
| score on a scale | supportED Group | Control Group |
|---|---|---|
| Baseline | 41.02 (38.16 to 43.87) | 41.02 (38.16 to 43.87) |
| Post gameplay | 42.21 (39.2 to 45.22) | 42.53 (39.49 to 45.58) |
| 3 month | 43.25 (39.79 to 46.71) | 42.57 (38.97 to 46.18) |
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.
| days | supportED Group | Control Group |
|---|---|---|
| Baseline-Alcohol | 0.0322581 ± 0.1796053 | 0.137931 ± 0.5157614 |
| 3 months-Alcohol | 0 ± 0 | 0 ± 0 |
| Baseline-Tobacco | 0 ± 0 | 0 ± 0 |
| 3 month-Tobacco | 0 ± 0 | 0 ± 0 |
| Baseline-Marijuana | 0 ± 0 | 0 ± 0 |
| 3 month-Marijuana | 0 ± 0 | 0 ± 0 |
The Ask Suicide Screen Questions (ASQ) is a validated 5-question screening tool to determine suicide risk.
Results for this outcome have not been posted.
Collected over up to 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| supportED Group | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Control Group | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Age, Continuous(years) | supportED Group | Control Group | Total |
|---|---|---|---|
| Mean | 15.96 ± 1.02 | 16.63 ± 1.25 | 16.18 ± 1.14 |
| Sex: Female, Male(Participants) | supportED Group | Control Group | Total |
|---|---|---|---|
| Female | 17 | 17 | 34 |
| Male | 14 | 12 | 26 |
| Ethnicity (NIH/OMB)(Participants) | supportED Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 22 | 19 | 41 |
| Not Hispanic or Latino | 9 | 10 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | supportED Group | Control Group | Total |
|---|---|---|---|
| Race — American Indian or Alaska Native | 0 | 1 | 1 |
| Race — Asian | 1 | 4 | 5 |
| Race — Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Race — Black or African American | 4 | 3 | 7 |
| Race — White | 17 | 12 | 29 |
| Race — More than one race | 4 | 4 | 8 |
| Race — Unknown or Not Reported | 4 | 5 | 9 |
| Race — Other | 1 | 0 | 1 |
| Region of Enrollment(participants) | supportED Group | Control Group | Total |
|---|---|---|---|
| United States | 31 | 29 | 60 |
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