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

NCT ID: NCT05517382

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-21
• Study Completion Date: 2023-05-11

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.).

Conditions

Substance Misuse; Suicide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

supportED

Intervention Type: OTHER

suicide prevention videogame

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.

Group Type: OTHER

Control

Intervention Type: OTHER

non-health related videogame

Interventions

supportED

suicide prevention videogame

Intervention Type: OTHER

Control

non-health related videogame

Intervention Type: OTHER

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2KL2TR001862-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000031180

Identifier Type: -

Identifier Source: org_study_id