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NCT06665620 | NOT YET RECRUITING | Suicide


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

Ksana Health

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).

Condition or disease

Suicide

Mental Health Disorder

Anhedonia

Intervention/treatment

ViraBrite nudges

Phase

NA

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
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : BRITE 2.0: a Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents
Actual Study Start Date : 2025-01
Estimated Primary Completion Date : 2025-04
Estimated Study Completion Date : 2025-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 13 Years to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

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

Location Details

NCT06665620


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How to Participate

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Locations


Not yet recruiting

United States, Pennsylvania

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15219

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