Adults 13 to 19, any sex, with Substance Misuse or Suicide. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Measuring Usability at Post-GameplayPrimary· 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.
Total score mean
Group
Value
95% CI
supportED Group
2.73
± 0.52
Usefulness
Group
Value
95% CI
supportED Group
4.39
± 1.70
Ease of use
Group
Value
95% CI
supportED Group
4.58
± 1.50
Satisfaction
Group
Value
95% CI
supportED Group
4.69
± 1.76
Ease of learning
Group
Value
95% CI
supportED Group
5.07
± 1.76
Assessing the Digital Experience at Post-GameplayPrimary· 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.
Group
Value
95% CI
supportED Group
32
supportED Group
27
Measuring User Experience at Post-GameplayPrimary· 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.
Group
Value
95% CI
supportED Group
2.73
± 0.52
Measuring Feasibility at Post-GameplayPrimary· 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.
RedCap Malfunction
Group
Value
95% CI
supportED Group
6
Incomplete assent form signed off on
Group
Value
95% CI
supportED Group
2
3-month form (first 3 measures) were completed at baseline.
Group
Value
95% CI
supportED Group
1
Change From Baseline in Coping Strategies on Brief COPE Scale at Post-gameplay and 3-monthsSecondary· 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.
Baseline
Group
Value
95% CI
supportED Group
60.72
57.26 – 64.17
Control Group
60.72
57.26 – 64.17
Post gameplay
Group
Value
95% CI
supportED Group
58.92
55.19 – 62.64
Control Group
57.02
53.25 – 60.79
3 months
Group
Value
95% CI
supportED Group
63.36
59.23 – 67.49
Control Group
62.91
58.48 – 67.34
Change From Baseline in Emotion Regulation at Post-gameplay and 3-monthsSecondary· 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.
Baseline
Group
Value
95% CI
supportED Group
45.18
42.34 – 48.02
Control Group
45.18
42.34 – 48.02
Post gameplay
Group
Value
95% CI
supportED Group
40.72
37.95 – 43.50
Control Group
42.84
39.99 – 45.69
3 months
Group
Value
95% CI
supportED Group
42.72
39.35 – 46.10
Control Group
45.58
42.08 – 49.08
Percentage of Adolescents Thriving Post-gameplay and 3-months.Secondary· 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.
Baseline
Group
Value
95% CI
supportED Group
41.9
Control Group
58.6
Post game
Group
Value
95% CI
supportED Group
51.6
Control Group
58.6
3 month
Group
Value
95% CI
supportED Group
58.1
Control Group
57.1
Change From Baseline in Mindfulness at Post Gameplay and 3-monthsSecondary· 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.
Baseline
Group
Value
95% CI
supportED Group
3.47
3.35 – 3.59
Control Group
3.47
3.35 – 3.59
Post gameplay
Group
Value
95% CI
supportED Group
3.46
3.32 – 3.59
Control Group
3.37
3.23 – 3.50
3 months
Group
Value
95% CI
supportED Group
3.44
3.29 – 3.59
Control Group
3.28
3.13 – 3.43
Change From Baseline in Intentions to Use a Safety Approach at Post-gameplay and 3-months.Secondary· 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.
Baseline
Group
Value
95% CI
supportED Group
15.78
14.33 – 17.24
Control Group
15.78
14.33 – 17.24
Post gameplay
Group
Value
95% CI
supportED Group
17.84
16.12 – 19.55
Control Group
16.38
14.63 – 18.13
3 months
Group
Value
95% CI
supportED Group
16.65
13.99 – 19.31
Control Group
17.59
14.81 – 20.38
Change From Baseline in Knowledge About the Safety Planning Approach at Post-gameplay and 3-months.Secondary· 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.
Baseline
Group
Value
95% CI
supportED Group
6.32
5.92 – 6.71
Control Group
6.32
5.92 – 6.71
Post gameplay
Group
Value
95% CI
supportED Group
6.3
5.78 – 6.82
Control Group
6.23
5.7 – 6.76
3 months
Group
Value
95% CI
supportED Group
6.27
5.74 – 6.81
Control Group
6.13
5.58 – 6.68
Change From Baseline in Severity of Suicidal Thoughts and Associative Behaviors on Concise Health Risk Tracking Self-Report (CHRT-SR) at 3-months.Secondary· 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.
Baseline
Group
Value
95% CI
supportED Group
9.33
7.23 – 11.43
Control Group
9.33
7.23 – 11.43
3 months
Group
Value
95% CI
supportED Group
8.26
5.61 – 10.91
Control Group
7.24
4.44 – 10.04
Change From Baseline in Anxiety at 3-months.Secondary· 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.
Baseline
Group
Value
95% CI
supportED Group
5.25
3.84 – 6.66
Control Group
5.25
3.84 – 6.66
3 month
Group
Value
95% CI
supportED Group
3.59
2.10 – 5.08
Control Group
4.41
2.84 – 5.99
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Yale University
Last refreshed: 10 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05517382.