Clinical trial NCT06665620: Optimizing a Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents
Official title: BRITE 2.0: a Just-in-time Adaptive Intervention for Suicide Safety Planning in Adolescents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicide
Mental Health Disorder
Anhedonia
Keywords: depression
depressive disorder
mood disorder
mental disorders
suicidal behaviors
suicidal thoughts
suicidal ideation
Lead sponsor: Ksana Health
Sponsor class: INDUSTRY
Collaborators: name: University of Pittsburgh Medical Center
name: National Institute of Mental Health (NIMH)
First posted: 2024-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Proximal engagement with ViraBrite
timeFrame: 24 hours
measure: Engagement with ViraBrite
timeFrame: 4 weeks
Secondary outcomes:
measure: Mood and Feelings Questionnaire (MFQ)
timeFrame: 4 weeks
measure: Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: 4 weeks
measure: Screen for Anxiety Related Emotional Disorders (SCARED)
timeFrame: 4 weeks
measure: Reasons for Living
timeFrame: 4 weeks
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Weekly
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References: