Actively Recruiting

Phase Not Applicable
Age: 13Years - 18Years
All Genders
ID05920252

Development and Testing of a Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide

Led by Ksana Health · Updated on 2026-03-04

78

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

K

Ksana Health

Lead Sponsor

C

Columbia University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Suicide is the second leading cause of death among youth, and rates in the US are rising despite prevention efforts. Researchers are evaluating a digital platform called Vira to improve how care is delivered to adolescents at high risk for suicide. This platform aims to use smartphone data and secure communication tools to better understand and manage risk factors like psychological distress, anhedonia, behavioral withdrawal, and sleep problems in young people receiving intensive outpatient treatment. The study compares two groups of adolescent patients aged 13 to 18 years old who are in an intensive outpatient Dialectical Behavior Therapy (DBT) program. One group uses the Vira platform, which collects data passively from smartphone sensors about activity, sleep, mobility, and mood-related language. Vira also prompts daily check-ins and supports practitioners with reminders to encourage behavior changes. The other group receives the usual treatment with the addition of a passive monitoring app called EARS. Participants will use their assigned app during their intensive outpatient treatment. Researchers will assess outcomes using tools like the Columbia Suicide Severity Rating Scale and Scale for Suicidal Ideation over six months. Other measures include anxiety, risky behaviors, sleep quality, mood, and pleasure scales at three and six months. The study monitors clinical outcomes to determine if the digital platform enhances care for youth at risk of suicide.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 13Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 Program
  • Aged 13 to 18 years old
  • Owns a personal smartphone (Android or iPhone 7+)
  • Fluent in English
Not Eligible

You will not qualify if you...

  • Adolescents who require a higher level of care (i.e., not admitted to the Intensive Outpatient DBT program)
  • Adolescents already assigned a clinician in the Intensive Adolescent and Family DBT program

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of intensive outpatient treatment

Participants receive intensive outpatient Dialectical Behavior Therapy (DBT) supported either by the Vira digital platform or treatment as usual. The Vira platform includes a smartphone app that passively collects data and prompts daily check-ins to support behavior change and therapy.

Regular visits as part of intensive outpatient program

Follow-up

Duration - Up to 6 months

Participants are assessed for clinical outcomes including suicidal ideation, anxiety, sleep quality, and mood at 3 and 6 months after treatment begins.

Assessments at 3 and 6 months

Trial Site Locations

Total: 1 location

1

Columbia University

New York, New York, United States, 10032

Actively Recruiting

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Research Team

R

Randy Auerbach, PhD, ABPP

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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