Optimizing a Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents

BRITE 2.0: A Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents

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 need to be addressed. This 4-week Micro-Randomized Trial (MRT) will optimize specific components of ViraBrite, an augmented version of the BRITE suicide safety planning app that integrates automated algorithms (i.e., just in time adaptive intervention features) 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).

Study Overview

• Status: Active, not recruiting
• Conditions: Anhedonia; Suicide; Mental Health Disorder
• Intervention / Treatment: Behavioral: ViraBrite nudges

Detailed Description

The goal of the MRT is to optimize the ViraBrite intervention by randomly assigning participants to various combination of notification timing (e.g., morning, midday, evening). Participants will download the ViraBrite suicide safety planning app that integrates automated algorithms (i.e., just in time adaptive intervention features) 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). The MRT will last for 4 weeks for each participant. Each day, participants will receive prompts ("nudges") according to a micro-randomized pattern that encourage them to access the ViraBrite app and utilize suicide safety planning skills. One decision point will occur per day. At each decision point, participants will have a seventy-five percent chance of receiving a nudge. Given that they are randomized to receive a nudge, participants have a 33.3% chance of receiving a notification at one of three time points: morning, midday or evening. The MRT will also investigate the impact of estimated emotional distress as a moderator of responding to the nudge. Specifically, measures of distress including 1. Self-report of daily mood, 2. Linguistic markers of distress (i.e., first person pronoun use) and 3. Geolocation will be explored as moderators of engagement with nudges.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Recent suicide attempt or ideation with a plan
• English fluency and literacy
• Parent or legal guardian willing and able to legally provide informed consent

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ViraBrite; Each day, participants will receive nudges according to a micro-randomized pattern that encourage them to access the ViraBrite app and utilize coping and suicide safety planning skills. One decision point will occur per day. At each decision point, participants will have a seventy-five percent chance of receiving a nudge. Given that they are randomized to receive a nudge, participants have a 33.3% chance of receiving a notification at one of three time points: morning, midday or evening.

Behavioral: ViraBrite nudges; Each day, participants will receive prompts via smartphone notifications that encourage them to access the ViraBrite app and utilize suicide safety planning skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proximal engagement with ViraBrite	Engagement with the ViraBrite app (i.e., tapping on the push notification, patterns of accessing app features such as coping skills and safety plan) between the current and next randomization	24 hours
Engagement with ViraBrite	Engagement over the course of the trial will be measured through objective app usage metrics, including total number and frequency of features used	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks
Snaith-Hamilton Pleasure Scale (SHAPS)	The SHAPS is a 14-item scale that measures anhedonia. The items cover the domains of social interaction, food and drink, sensory experience, and interest/pastimes. A score of 2 or less constitutes a "normal" score, while an "abnormal" score is defined as 3 or more. Each item has four possible responses: strongly disagree, disagree, agree, or strongly agree. Either of the "disagree" responses score one point, and either of the "agree" responses score 0 points. Thus, the final score ranges from 0 to 14. Higher scores indicate greater anhedonia.	4 weeks
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.	4 weeks
Reasons 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.	4 weeks
Columbia Suicide Severity Rating Scale (C-SSRS)	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).	Weekly

Collaborators and Investigators

• Sponsor: Ksana Health
• Collaborators: National Institute of Mental Health (NIMH); University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: depression; suicidal ideation; mood disorder; depressive disorder; mental disorders; suicidal behaviors; suicidal thoughts
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Behavioral Symptoms; Neurobehavioral Manifestations; Self-Injurious Behavior; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Suicide; Suicidal Ideation; Depression; Depressive Disorder; Mood Disorders; Mental Disorders; Anhedonia
• Other Study ID Numbers: OV-003; R44MH135605 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No