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Active, Not Recruiting

NCT Number: NCT06665620

Optimizing 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Suicide Anhedonia Behavior Behavioral Symptoms Depression Depressive Disorder Mental Disorders Mental Health Disorder Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Self-Injurious Behavior Signs and Symptoms Suicidal Ideation

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ViraBrite nudges

Behavioral

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

Primary outcomes

  1. Proximal engagement with ViraBrite

    Time frame: 24 hours

    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

  2. Engagement with ViraBrite

    Time frame: 4 weeks

    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

  1. Mood and Feelings Questionnaire (MFQ)

    Time frame: 4 weeks

    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.

  2. Snaith-Hamilton Pleasure Scale (SHAPS)

    Time frame: 4 weeks

    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.

  3. Screen for Anxiety Related Emotional Disorders (SCARED)

    Time frame: 4 weeks

    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. Reasons for Living

    Time frame: 4 weeks

    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.

  5. Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Weekly

    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).

Sponsors and collaborators

Lead sponsor

Ksana Health

Industry

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of Pittsburgh Medical Center

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 30, 2024
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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