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

Primary Purpose

Substance Misuse, Suicide

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
supportED
Control
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Misuse

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • attend a high school that has a school-based behavioral provider
  • be considered at greater risk of suicidal thoughts and behaviors due to report of previous substance misuse in their lifetime
  • be willing to sit for a single session to complete pre-/post-assessments, engage with the game (~45min), and participate in a post-gameplay focus group (if in the experimental group) for 60min
  • provide assent and parental/guardian consent (if<age 18).

Exclusion Criteria:

-

Sites / Locations

  • Yale

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

supportED group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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. Higher scores indicate higher game usability. An additional 6-items ask participants about the top 3 most negative and top 3 most positive aspects of the digital experience.
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. Higher scores indicate higher user engagement.
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.
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. Successful completion of protocols and procedures and minimal amendments through IRB indicate feasibility of the digital game intervention.

Secondary Outcome Measures

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 5= I've been doing this a lot. Higher scores indicate increased utilization of coping strategies within and across domains.
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. Higher scores indicate higher levels of state emotion regulation.
Change from Baseline in Adolescent Well-Being at 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.
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. Higher scores indicate higher levels of mindfulness.
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 adapted from Addis et al., 2013. Responses are measured on a 5-point likert scale where 1= strongly disagree and 5= strongly agree. Higher scores indicate increased intentions to use a safety planning approach.
Change from Baseline in Knowledge about the Safety Planning Approach at post-gameplay and 3-months.
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. Higher scores indicate increased knowledge about gameplay content.
Change from Baseline in Severity of Suicidal Thoughts and Associative Behaviors on Concise Health Risk Tracking Self-Report (CHRT-SR) at 3-months.
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 1= strongly disagree and 5= strongly agree. Higher scores indicate increased severity of suicidal thoughts and associative behaviors.
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. Higher scores indicate increased levels of anxiety.
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. Higher scores indicate increased levels of depression.
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. Higher scores indicate increased help-seeking behavior.
Change from Baseline in Substance Misuse in the Past 30-Days at 3-months
Participants will complete surveys through a secured, data management system (RedCap). Substance misuse of alcohol, tobacco/vaping, cannabis, legal and illegal opioids in the past 30-days will be measured as a possible mediator. These measures are self-reported. Responses indicate frequency of use within past 30-days.
Change from Baseline in Suicide Risk at 3-months
Participants will complete surveys through a secured, data management system (RedCap). The Ask Suicide Screen Questions (ASQ) is a validated 5-question screening tool to determine potential suicide risk (question 1-4) and imminent suicide risk (question 5).

Full Information

First Posted
August 23, 2022
Last Updated
September 8, 2023
Sponsor
Yale University
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT05517382
Brief Title
A Digital Game Targeting Suicide Prevention in Adolescents Who Report Substance Misuse
Official Title
A Digital Game Targeting Suicide Prevention in Adolescents Who Report Substance Misuse (Formative Work and Pilot Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 21, 2022 (Actual)
Primary Completion Date
February 2, 2023 (Actual)
Study Completion Date
May 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary aim of this study is to design and develop a digital game that models the process of a safety planning intervention. To do so, the investigators will explore and better understand peer or student perceptions around potential warning signs, coping strategies, and seeking help among youth who may be at greater risk of suicide due to misuse of substances. Focus groups/interviews with adolescents, young adults, adults, and school-based behavioral health providers will be conducted. Findings will inform the development of a digital intervention to reduce the risk of suicide among adolescents who misuse substances. Once a prototype of the game is developed, play-test focus groups with adolescents, college-aged youth, and school-based mental health providers will be conducted to finalize the intervention. Once finalized, the investigators will conduct a pilot study with 60 adolescents aged 13-19 to assess user experience, acceptability and feasibility of the digital game.
Detailed Description
Formative Work: In year 1, the aim is to design and develop a digital game that models the process of a safety planning intervention. To do so, the investigators will explore and better understand peer or student perceptions around potential warning signs, coping strategies, and seeking help among youth who may be at greater risk of suicide due to misuse of substances. Focus groups with adolescents, college-aged youth, and school-based mental health providers will be conducted. Findings will inform the development of a digital intervention to reduce the risk of suicide among adolescents who misuse substances. Once a prototype of the game is developed, the investigators will conduct play-test focus groups with adolescents and school-based mental health providers to finalize the digital game. The focus of this clinical trial is the Pilot RCT: In year 2, the investigators will assess user experience, acceptability, and feasibility of the game as well as explore the following proximal outcomes such as but not limited to adolescent well-being, intentions to use a safety planning intervention, coping strategies, substance misuse in last 30 days, and associated risk factors related to suicidal risk (e.g., hopelessness, impulsivity, etc.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Misuse, Suicide

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eligible individuals will be assigned to either the 1) supportED group (n=30) or 2) control group (n=30).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
supportED group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
supportED
Intervention Description
suicide prevention videogame
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
non-health related videogame
Primary Outcome Measure Information:
Title
Measuring Usability at Post-Gameplay
Description
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. Higher scores indicate higher game usability. An additional 6-items ask participants about the top 3 most negative and top 3 most positive aspects of the digital experience.
Time Frame
Immediately after Gameplay, up to 30 minutes
Title
Measuring User Experience at Post-Gameplay
Description
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. Higher scores indicate higher user engagement.
Time Frame
Immediately after Gameplay, up to 30 minutes
Title
Measuring Acceptability at Post-Gameplay
Description
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
Title
Measuring Feasibility at Post-Gameplay
Description
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. Successful completion of protocols and procedures and minimal amendments through IRB indicate feasibility of the digital game intervention.
Time Frame
Immediately after Gameplay, up to 30 minutes
Secondary Outcome Measure Information:
Title
Change from Baseline in Coping Strategies on brief COPE Scale at post-gameplay and 3-months
Description
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 5= I've been doing this a lot. 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.
Title
Change from Baseline in Emotion Regulation at post-gameplay and 3-months
Description
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. Higher scores indicate higher levels of state emotion regulation.
Time Frame
Baseline, Immediately after Gameplay, up to 30 minutes, and at 3-months
Title
Change from Baseline in Adolescent Well-Being at post-gameplay and 3-months.
Description
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.
Time Frame
Baseline, Immediately after Gameplay, up to 30 minutes, and at 3-Months.
Title
Change from Baseline in Mindfulness at post gameplay and 3-months
Description
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. Higher scores indicate higher levels of mindfulness.
Time Frame
Baseline, Immediately after Gameplay, up to 30 minutes, and at 3-months
Title
Change from Baseline in Intentions to Use a Safety Approach at post-gameplay and 3-months.
Description
Participants will complete surveys through a secured, data management system (RedCap). Intentions to use a safety plan is a 7-item measure adapted from Addis et al., 2013. Responses are measured on a 5-point likert scale where 1= strongly disagree and 5= strongly agree. 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.
Title
Change from Baseline in Knowledge about the Safety Planning Approach at post-gameplay and 3-months.
Description
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. Higher scores indicate increased knowledge about gameplay content.
Time Frame
Baseline, Immediately after Gameplay, up to 30 minutes, and at 3-Months
Title
Change from Baseline in Severity of Suicidal Thoughts and Associative Behaviors on Concise Health Risk Tracking Self-Report (CHRT-SR) at 3-months.
Description
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 1= strongly disagree and 5= strongly agree. Higher scores indicate increased severity of suicidal thoughts and associative behaviors.
Time Frame
Baseline, and at 3-Months.
Title
Change from Baseline in Anxiety at 3-months.
Description
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. Higher scores indicate increased levels of anxiety.
Time Frame
Baseline, and at 3-Months.
Title
Change from Baseline in Depression at 3-months.
Description
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. Higher scores indicate increased levels of depression.
Time Frame
Baseline, and at 3-Months.
Title
Change from Baseline in Help-Seeking Behavior at post-gameplay and 3-months.
Description
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. Higher scores indicate increased help-seeking behavior.
Time Frame
Baseline, Immediately after Gameplay, up to 30 minutes, and at 3-Months.
Title
Change from Baseline in Substance Misuse in the Past 30-Days at 3-months
Description
Participants will complete surveys through a secured, data management system (RedCap). Substance misuse of alcohol, tobacco/vaping, cannabis, legal and illegal opioids in the past 30-days will be measured as a possible mediator. These measures are self-reported. Responses indicate frequency of use within past 30-days.
Time Frame
Baseline, and at 3-Months.
Title
Change from Baseline in Suicide Risk at 3-months
Description
Participants will complete surveys through a secured, data management system (RedCap). The Ask Suicide Screen Questions (ASQ) is a validated 5-question screening tool to determine potential suicide risk (question 1-4) and imminent suicide risk (question 5).
Time Frame
Baseline, and at 3-Months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: attend a high school that has a school-based behavioral health provider be fluent in reading English during the consent/assent process be willing to sit for a single session to complete pre-/post-assessments, engage with the game (~45min), and participate in a post-gameplay focus group (if in the experimental group) for 60min provide assent and parental/guardian consent (if<age 18). Exclusion Criteria: Any student who is actively suicidal and/or moderately severe to severely depressed will be flagged and immediately connected to the school-based provider on site. If a student indicates moderately severe to severe symptoms of depression, student will be flagged and immediately connected to the school-based provider for a risk assessment and will follow appropriate school protocols. If student is cleared by the school-based provider, student may continue in the study and the school -based provider will follow up with student in two weeks. If a student screens positive for suicide (but is not acutely suicidal), student will be flagged and immediately connected to school-based provider for a risk assessment and will follow appropriate school protocols. If student is cleared by school-based provider, student may continue in study and the school-based provider will follow up with student in two weeks. If student is acutely suicidal, student will be flagged and immediately connected to school-based provider who will follow school protocol (e.g., contact 211, contact parent/guardian, etc.). They will be ineligible to participate in the study on this day. Student may not return to rescreen for participation for at least 2 weeks and only when they are no longer actively suicidal. Rescreening: Participants will not have to repeat the questions related to static variables (such as demographics and past experiences), but the baseline assessment of dynamic variables will need to be repeated and meet eligibility requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia-Santi F Fernandes, Ed.D., LPC
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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

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