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| ID | Type | Description | Link |
|---|---|---|---|
| 2KL2TR001862-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| supportED group | Experimental | 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. |
|
| Control group | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| supportED | Other | suicide prevention videogame |
| |
| Control |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Immediately after Gameplay, up to 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, and at 3-Months. |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia-Santi F Fernandes, Ed.D., LPC | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale | New Haven | Connecticut | 06519 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This outcome was not collected for the control arm. | Posted | Mean | Standard Deviation | score on a scale | Immediately after Gameplay, up to 30 minutes |
|
up to 3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claudia-Santi Fernandes | Yale University | 203-785-2885 | Claudiasanti.fernandes@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2023 | Jan 23, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 21, 2022 | Mar 7, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013405 | Suicide |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Not provided
| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
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Eligible individuals will be assigned to either the 1) supportED group (n=30) or 2) control group (n=30).
Not provided
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Not provided
| Other |
non-health related videogame |
|
| 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. | Immediately after Gameplay, up to 30 minutes |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, and at 3-Months. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | All coded statements provided in the open ended question. This outcome was not collected for the control arm. | Posted | Count of Units | statements | Immediately after Gameplay, up to 30 minutes | statements | statements |
|
|
|
| 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. | This outcome was not collected for the control arm. | Posted | Mean | Standard Deviation | score on a scale | Immediately after Gameplay, up to 30 minutes |
|
|
|
| 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. | Survey was redundant and therefore removed. This data was not collected. | Posted | Immediately after Gameplay, up to 30 minutes |
|
|
| 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. | Posted | Number | deviations | Immediately after Gameplay, up to 30 minutes |
|
|
|
| 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. | one participant did not complete 3 month follow up | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months. |
|
|
|
| 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. | one participant did not complete 3 month follow up | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-months |
|
|
|
| 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. | one participant did not complete 3 month follow up | Posted | Number | percentage of participants | Immediately after Gameplay (up to 30 minutes), and at 3-Months. |
|
|
|
|
| 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. | one participant did not complete 3 month follow up | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-months |
|
|
|
|
| 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. | one participant did not complete 3 month follow up | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months. |
|
|
|
| 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. | one participant did not complete 3 month follow up | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months |
|
|
|
| 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. | one participant did not complete 3 month follow up | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, and at 3-Months. |
|
|
|
| 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. | one participant did not complete 3 month follow up | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, and at 3-Months. |
|
|
|
| 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. | one participant did not complete 3 month follow up | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, and at 3-Months. |
|
|
|
| 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. | one participant did not complete 3 month follow up | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months. |
|
|
|
| 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. | One participant did not complete 3 month follow up | Posted | Mean | Standard Deviation | days | Baseline, and at 3-Months. |
|
|
|
| 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. | Not Posted | Baseline, and at 3-Months. | Participants |
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | 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 | 0 | 29 | 0 | 29 | 0 | 29 |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Post gameplay |
|
|
| 3 months |
|
|
| Post gameplay |
|
|
| 3 months |
|
|
| Post game |
|
|
| 3 month |
|
|
| 0.59 |
| Superiority |
| At 3 month | t-test, 2 sided | 0.94 | Superiority |
| GEE | Controlling for baseline thriving status, this reflects the interaction between the intervention group and time. | 0.55 | Superiority |
| 3 months |
|
| Mixed Models Analysis |
| 0.0857 |
| Mean Difference (Net) |
| -0.16 |
| 2-Sided |
| 95 |
| -0.35 |
| 0.02 |
Group effect. |
| Superiority |
| Post gameplay |
|
|
| 3 months |
|
|
| Post gameplay |
|
|
| 3 months |
|
|
| 3 months |
|
|
| 3 month |
|
|
| 3 month |
|
|
| Post gameplay |
|
|
| 3 month |
|
|
| 3 months-Alcohol |
|
|
| Baseline-Tobacco |
|
|
| 3 month-Tobacco |
|
|
| Baseline-Marijuana |
|
|
| 3 month-Marijuana |
|
|