Digitally Assisted Risk Reduction for Youth at High Risk for Suicide

This study is testing a new digital platform called Vira to help young people (ages 13-18) who are at high risk for suicide and are already in an intensive outpatient treatment program. Vira is an app on your smartphone that collects information like your physical activity, sleep, and how you use language, which can show changes in mood. This information helps your care team better understand your risk factors. The study compares Vira with standard treatment (Intensive Outpatient DBT) plus another app (EARS) that also monitors data. We want to see if Vira can help reduce suicidal thoughts and behaviors over 6 months. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 78 participants. Participants will be randomly assigned to either the Vira group or the standard treatment group.
What's involved
Participants will be receiving treatment at the Intensive Adolescent and Family DBT Program. The Vira app or EARS app will be installed on your smartphone.
Compensation
Not stated in the trial record.
Follow-up
Your suicidal thoughts and behaviors will be measured at 6 months after starting the study.

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NCT05920252

A Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide

Recruiting
NAAges 13–18InterventionalTreatment
Ksana Health
~78 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:ViraTreatment as Usual (TAU)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Columbia Suicide Severity Rating Scale (C-SSRS)
Measured over 6 months
+1 more outcome measured
Suicide
Mental Health Disorder
Anhedonia
1 sites across 1 states
New York1
  • Nick Allen, PhD · PRINCIPAL_INVESTIGATOR · Ksana Health

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Written informed assent from adolescents ages 13-17 years old and permission from legal guardians, or consent from adolescents age 18 years old.
Receiving treatment at the Intensive Adolescent and Family DBT Pgogram
13-18 years old
Owns a personal smartphone (Android or iPhone 7+)
Fluent in English

Exclusion

Adolescents who require a higher level of care (i.e., are not admitted to the Intensive Outpatient DBT program)
Adolescents who are receiving treatment at the Intensive Adolescent and Family DBT program and have already been assigned a clinician
  • Columbia Suicide Severity Rating Scale (C-SSRS)6 months

    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).

  • Scale for Suicidal Ideation (SSI)6 months

    The SSI consists of 19 items that evaluate three dimensions of suicide ideation: active suicidal desire, specific plans for suicide, and passive suicidal desire. Each item is rated on a 3-point scale from 0 to 2. The higher the total score, the greater the severity of suicide ideation.