NCT07348666 · Ksana Health
A Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents
(ViraSafeRCT)
What this study is about
Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to increase engagement with effective interventions such as suicide safety planning.
View original scientific description
Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death amongst youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to increase engagement with effective interventions such as suicide safety planning. The BRITE suicide safety planning app was developed on evidence-based principles and has undergone rigorous formative development and effectiveness evaluations. However, to optimize its functionality, commercial viability, and scale its implementation, issues related to user engagement needed to be addressed. This 3 month Pragmatic Randomized Trial will evaluate the impact of the ViraSafe app-an enhanced version of the BRITE suicide safety planning app-on improving engagement with coping skills and safety planning among suicidal adolescents by comparing its intervention components to those of the original BRITE app.
Interventions
BEHAVIORAL
ViraSafe: Treatment pushes
ViraSafe participants will complete a safety plan with their provider. Safety plan content will be editable and viewable throughout the intervention for both participants and their providers. Participants will be able to access the safety plan at any time in ViraSafe. Additionally, patients using ViraSafe will be prompted to complete a daily distress rating. ViraSafe uses automated algorithms (i.e., just in time adaptive intervention features) and user input from distress ratings to facilitate increased engagement with coping skills and pushes safety planning materials to users at periods of high risk (i.e., increases in emotional distress). In addition to the just-in-time reminders (i.e., nudges) pushed automatically by the system, through the Vira Pro platform, practitioners can schedule just-in-time reminders (i.e., "nudges") to arrive in the user's phone to support their behavior change plan.
BEHAVIORAL
BRITE
The BRITE app contains the teen's safety plan, links to videos of how to use coping strategies they indicated in their safety plan that have been useful for them (like guided mediation or deep breathing), a library of evidence-based and age-appropriate coping skills and strategies that the adolescent can learn more about, photos or videos that the adolescent has uploaded to the app, and includes a question asking them to rate their distress level in the moment: "What is your distress level right now?" (1 is "Least Distressed" to 5, which is "Most Distressed"). Then, the teen is asked to identify the feeling that fits their distress level via 12 emoji images: "Which feelings fit your distress level?" Based on adolescent's distress rate, the BRITE app suggests coping skills or "activities" for the adolescent to lower their distress level.
Primary outcome measures
Proximal Engagement
Time frame: 24 hours
Engagement with the ViraSafe app (i.e., tapping on the push notification, patterns of accessing app features such as coping skills and safety plan) and BRITE app (daily dose rating, post rating after accessing coping skill, editing coping skill content)
Engagement with the apps
Time frame: 3 months
Engagement over the course of the trial will be measured through objective app usage metrics, including total number and frequency of features used.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Youth (minors):
- 13-17 years old
- Suicide attempt in the last year and ideation in the past month
- English fluency and literacy
- Parent or legal guardian willing and able to legally provide informed consent
- Receiving care at one of the study clinical settings with trained providers to onboard ViraSafe or BRITE safety plan Youth (adults)
- 18-24 years old
- Recent suicide attempt or ideation with a plan
- English fluency and literacy
- Receiving care at one of the study clinical settings with trained providers to onboard ViraSafe or BRITE safety plan.
Exclusion criteria
- Youth (minors):
- Unable to read/understand English
- Current manic or psychotic episode
- Development disability precluding comprehension of study procedures
- No routine access to a mobile phone, assessed by EHR review and during phone screen
- No eligible parent or legal guardian to provide informed consent Youth (adults):
- Unable to read/understand English
- Current manic or psychotic episode
- Development disability precluding comprehension of study procedures
- No routine access to a mobile phone, assessed by EHR review and during phone screen
Where
- Eugene, Oregon
- Pittsburgh, Pennsylvania
Collaborators
National Institute of Mental Health (NIMH), University of Pittsburgh Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 12, 2026 · Source of record for eligibility and locations