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

NCT06665620 | Active Not Recruiting DMC

• 2 other identifiers: OV-003R44MH135605
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Suicide; Anhedonia; Mental Health Disorder

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Mood and Feelings Questionnaire (MFQ)

  4 weeks

• Snaith-Hamilton Pleasure Scale (SHAPS)

  4 weeks

• Screen for Anxiety Related Emotional Disorders (SCARED)

  4 weeks

• Reasons for Living

  4 weeks

• Columbia Suicide Severity Rating Scale (C-SSRS)

  Weekly

Study Arms (1)

ViraBrite

EXPERIMENTAL

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

Interventions

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.

ViraBrite

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15219, United States

Location

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: At each decision point (once per day), participants will be randomized to receive a n nudge encouraging them to access the ViraBrite app and utilize suicide safety planning skills vs. no nudge. 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.

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 30, 2024
• Study Start: July 16, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (1)