About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
ViraSafe: Treatment pushes
BehavioralViraSafe 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.
BRITE
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Proximal Engagement
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
Engagement over the course of the trial will be measured through objective app usage metrics, including total number and frequency of features used.
Secondary outcomes
Technology Acceptance
Mixed methods feedback on acceptability, usability, and satisfaction, including the System Usability Scale and items adapted from the Technology Acceptance Model (TAM). System Usability Scale: 10 items -- Brooke, J(1996) Technology Acceptance Model: 12 Items - Adapted from Davis, (1989) Participants rate the extent to which they agree with each statement by circling a number from one to seven arranged horizontally beneath anchor point descriptions "Strongly Agree," "Neutral," and "Strongly Disagree.
Suicide Risk Factors: Columbia Suicide Severity Rating Scale (CSSRS)
Changes in suicide risk factors from baseline to 3 months assessed through the Columbia Suicide Severity Rating Scale (CSSRS). The C-SSRS is an assessment of suicidal thoughts and behaviors in clinical and research settings. The C-SSRS consists of 16 questions about suicidal thoughts and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). This 5-item subscale ranges from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent).
Suicidal Risk Factors: Reason for Living
The Reasons for Living (RFL) Inventory is a 48-item instrument that measures a range of beliefs potentially important as reasons for not committing suicide. The items are rated on 6-point Likert type scales based on how important each reason would be for living if suicide was contemplated (1 = not at all important; 6 = extremely important). The total score is calculating by calculating the mean of the item scores and multiplying the result by 48. Total scores can only be calculated if a participant answers at least 38 items.
Other outcomes
Depressive Symptoms: Mood and Feelings Questionnaire (MFQ)
Changes in self-reported depressive symptoms from baseline to 3 months, assessed through the Mood and Feelings Questionnaire (MFQ). The MFQ is a 13-item self-report questionnaire used to screen for depressive in children and young people. Items are rated on a 3-point Likert scale (not true = 0; sometimes true = 1; not true = 2). Scores are calculated by summing the point values on each response. Total MFQ scores range from 0 to 26, with higher scores suggesting greater severity in depressive symptoms.
Anxiety Symptoms: the Screen for Anxiety Related Emotional Disorders (SCARED)
Changes in self-reported anxiety symptoms from baseline to 3 months, assessed through the Screen for Anxiety Related Emotional Disorders (SCARED) The SCARED is a 5-item self-report questionnaire used to screen for childhood anxiety disorders including general anxiety disorder, separate anxiety disorder, panic disorder, and social phobia. Items are rated on a 3-point Likert scale from 0 to 2 and summed to yield a total score. Total scores range from 0 to 10. Higher scores indicate greater anxiety.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ksana Health
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
University of Pittsburgh Medical Center
Collaborator