A Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents

NCT07348666 | Recruiting DMC

• 2 other identifiers: STUDY25040094R44MH135605
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

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

Suicide; Mental Health Disorder; Anhedonia

Keywords

depression; depressive disorder; mood disorder; mental disorders; suicidal behavior; suicidal thoughts; suicidal ideation

Outcome Measures

Primary Outcomes (2)

• 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)

  24 hours

• 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.

  3 months

Secondary Outcomes (3)

• Technology Acceptance

  3 months

• Suicide Risk Factors: Columbia Suicide Severity Rating Scale (CSSRS)

  3 months

• Suicidal Risk Factors: Reason for Living

  3 months

Other Outcomes (2)

• Depressive Symptoms: Mood and Feelings Questionnaire (MFQ)

  3 months

• Anxiety Symptoms: the Screen for Anxiety Related Emotional Disorders (SCARED)

  3 months

Study Arms (2)

ViraSafe

EXPERIMENTAL

The new augmented app that combines BRITE coping skills and safety planning into the Vira behavior change platform

Behavioral: ViraSafe: Treatment pushes

BRITE

ACTIVE COMPARATOR

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

Interventions

ViraSafe: Treatment pushes BEHAVIORAL

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.

ViraSafe

BRITE BEHAVIORAL

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.

BRITE

Eligibility Criteria

• Age: 13 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Youth (minors):
• 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)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ksana Health: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Pittsburgh Medical Center: collaborator

Study Sites (3)

Ksana Health Inc

Eugene, Oregon, 97405, United States

NOT YET RECRUITING

STAR Center, Western Psychiatric Institute & Clinic

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Suicide; Mental Disorders; Anhedonia; Depression; Depressive Disorder; Mood Disorders; Suicidal Ideation

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Stephanie Stepp, PhD

CONTACT

412-383-5051; steppsd@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The clinical assessor is masked to the intervention
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 16, 2026
• Study Start: June 18, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

US (3)