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Completed

NCT Number: NCT05517382

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

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.

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Key information

Conditions

Substance Misuse Behavior Behavioral Symptoms Self-Injurious Behavior Suicide

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale

New Haven, Connecticut, 06519, United States

About this study

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.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

supportED

Other

suicide prevention videogame

Control

Other

non-health related videogame

Primary outcomes

  1. Measuring Usability at Post-Gameplay

    Time frame: 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.

  2. Assessing the Digital Experience at Post-Gameplay

    Time frame: 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.

  3. Measuring User Experience at Post-Gameplay

    Time frame: 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.

  4. Measuring Acceptability at Post-Gameplay

    Time frame: Immediately after Gameplay, up to 30 minutes

    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.

  5. Measuring Feasibility at Post-Gameplay

    Time frame: 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.

Secondary outcomes

  1. Change From Baseline in Coping Strategies on Brief COPE Scale at Post-gameplay and 3-months

    Time frame: 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.

  2. Change From Baseline in Emotion Regulation at Post-gameplay and 3-months

    Time frame: 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.

  3. Percentage of Adolescents Thriving Post-gameplay and 3-months.

    Time frame: 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.

  4. Change From Baseline in Mindfulness at Post Gameplay and 3-months

    Time frame: 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.

  5. Change From Baseline in Intentions to Use a Safety Approach at Post-gameplay and 3-months.

    Time frame: 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.

  6. Change From Baseline in Knowledge About the Safety Planning Approach at Post-gameplay and 3-months.

    Time frame: 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.

  7. Change From Baseline in Severity of Suicidal Thoughts and Associative Behaviors on Concise Health Risk Tracking Self-Report (CHRT-SR) at 3-months.

    Time frame: 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.

  8. Change From Baseline in Anxiety at 3-months.

    Time frame: 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.

  9. Change From Baseline in Depression at 3-months.

    Time frame: Baseline, and 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.

  10. Change From Baseline in Help-Seeking Behavior at Post-gameplay and 3-months.

    Time frame: Baseline, Immediately after Gameplay (up to 30 minutes), and at 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.

  11. Mean Number of Days of Substance Misuse in the Past 30 Days

    Time frame: Baseline, and at 3-Months.

    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.

Other outcomes

  1. Change From Baseline in Suicide Risk at 3-months

    Time frame: Baseline, and at 3-Months.

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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

A Digital Game Targeting Suicide Prevention in Adolescents Who Report Substance Misuse (Formative Work and Pilot Study)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2022
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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