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

NCT ID: NCT06665620

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-16
• Study Completion Date: 2026-02-01

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).

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.

Conditions

Suicide; Mental Health Disorder; Anhedonia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ViraBrite nudges

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh Medical Center

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Ksana Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

R44MH135605

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OV-003

Identifier Type: -

Identifier Source: org_study_id