Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 13 Years and 24 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)
Masking Description
The clinical assessor is masked to the intervention

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ViraSafe
The new augmented app that combines BRITE coping skills and safety planning into the Vira behavior change platform
  • 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.
Active Comparator
BRITE
The original BRITE app that promotes self-monitoring and self-management by providing strategies to avoid or cope with triggers for suicidal urges and has been rigorously tested in clinical trials
  • 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.

Recruiting Locations

STAR Center, Western Psychiatric Institute & Clinic
Pittsburgh, Pennsylvania 15213
Contact:
David Brent Co-Director, MD
412-246-5619
Brentda@upmc.edu

University of Pittsburgh
Pittsburgh, Pennsylvania 15213
Contact:
Stephanie Stepp, Ph.D.
412-383-5051
steppsd@upmc.edu

More Details

Status
Recruiting
Sponsor
Ksana Health

Study Contact

Stephanie Stepp, PhD
412-383-5051
steppsd@upmc.edu

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.