BRITE 2.0: A Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents (ViraSafe RCT (SBIR Phase 2))

ViraSafe is an augmented version of the BRITE app that integrates the BRITE coping skills and safety planning content into a module within the Vira behavior change platform. Vira, a digital behavior change platform developed by Ksana Health, consists of a smartphone app for patients, along with integrated web portals for practitioners and for healthcare administrators and supervisors. The platform collects self-report and passive data on smartphone usage patterns, such as language use, physical activity, sleep, social interactions, and screen time, and uses these insights to provide objective and continuous measurements of mental health indicators.

Upon downloading the Vira app and accessing the ViraSafe module, 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.

After undergoing study screening procedures and providing informed consent/assent, participants will complete the baseline assessment (60 minutes) which will occur virtually over video conference software or phone call.

Additional self-reports collected at patient visit will be requested through informed consent process as some overlap with what research team plans to administer. Self-reports will be retrieved for data analysis at the timepoints that align with the study timepoints. Self-reports will be administered by research staff if not available from a clinic's measurement-based care system.

Following Baseline assessments, participants will be randomized in a 1:1 allocation to receive ViraSafe or BRITE (50 in each arm). Randomization will be based on age, sex, and suicide symptoms. At a scheduled patient visit in their clinical settings, onboarding to assigned app will occur. Onboarding involves downloading their assigned app from Google Play Store or Apple App Store. Each app involves a trained clinician from their clinic setting collaboratively completing a safety plan. If a mental health clinician is not available for onboarding after Baseline, a research clinician will assist with onboarding.

At 1-month timepoint, participants will repeat the assessment interview (which will occur virtually over video conference software or phone call) and self-report measures with additional items assessing acceptability, usability, and satisfaction using the Technology Acceptance Model (TAM) and System Usability Scale (SUS) (total assessment duration: 60 minutes). At the 3-month timepoint, participants will repeat the assessment interview (which will occur virtually over video conference software or phone call) and self-report measures (total duration: 60 minutes).

20 adolescent participants or as many that are needed to reach saturation who received ViraSafe intervention arm will be selected to complete a qualitative exit interview to provide additional feedback on the intervention (60 minutes). The interview guide will be developed closer to the time of first exit interview and submitted for approval to the IRB prior to completing interviews.