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

NCT05517382 | Completed Results DMC

• 2 other identifiers: 20000311802KL2TR001862-06
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Misuse; Suicide

Outcome Measures

Primary Outcomes (5)

• 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

• 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

Secondary Outcomes (11)

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

  Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months.

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

  Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-months

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

  Immediately after Gameplay (up to 30 minutes), and at 3-Months.

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

  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.

  Baseline, Immediately after Gameplay (up to 30 minutes), and at 3-Months.

Other Outcomes (1)

• Change From Baseline in Suicide Risk at 3-months

  Baseline, and at 3-Months.

Study Arms (2)

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.

Other: supportED

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.

Other: Control

Interventions

supportED OTHER

suicide prevention videogame

supportED group

Control OTHER

non-health related videogame

Control group

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Yale

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Suicide

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Claudia-Santi Fernandes
• Organization: Yale University

Claudiasanti.fernandes@yale.edu

203-785-2885

Study Officials

• Claudia-Santi F Fernandes, Ed.D., LPC

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible individuals will be assigned to either the 1) supportED group (n=30) or 2) control group (n=30).

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 26, 2022
• Study Start: December 21, 2022
• Primary Completion: February 2, 2023
• Study Completion: May 11, 2023
• Last Updated: April 10, 2024
• Results First Posted: April 10, 2024

Record last verified: 2024-03

Locations

US (1)