RecruitingNot ApplicableNCT05920252

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

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

Sponsor

Ksana Health

Enrollment

78 participants

Start Date

Aug 14, 2024

Study Type

INTERVENTIONAL

Conditions

Mental Health Disorder Suicide Anhedonia

Summary

Despite efforts to prevent suicide, US rates are climbing, and suicide is the second leading cause of death among youth. Digital tools, especially personal smartphones, are promising avenues to address these issues and can be used to provide a unique understanding of risk factors, including psychological distress, anhedonia and behavioral withdrawal, and sleep disturbance among high-risk individuals. This project aims to enhance the effectiveness of the delivery of preventative health care to youth at risk for suicide by developing a comprehensive digital platform that allows practitioners to integrate mobile sensing data and HIPAA-compliant client communication tools into their management of these young people.

Eligibility

Min Age: 13 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a digital app-based safety platform designed to support teenagers at high risk for suicide. The app works alongside an intensive outpatient therapy program called Dialectical Behavior Therapy (DBT), providing real-time digital tools to help teens and their care teams manage safety crises. Researchers want to know whether the platform is easy to use and helpful in reducing suicide risk. **You may be eligible if:** - You are a teenager aged 13–18 years old - You are currently enrolled in the Intensive Adolescent and Family DBT program - You own a smartphone (Android or iPhone 7 or newer) - You are fluent in English - A parent or guardian has provided consent (for ages 13–17) **You may NOT be eligible if:** - You need a higher level of care than the Intensive Outpatient DBT program currently provides - You are already enrolled in the DBT program and have already been assigned a clinician through an earlier enrollment process Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALVira

Intensive outpatient DBT supported by the Vira platform. The Vira app is installed on the patient's smartphone. The app passively collects data from phone sensors (i.e., measures of physical activity, sleep patterns, mobility, and language patterns reflecting mood states and cognition) that are indicative of risk-relevant behavioral patterns and psychological states. It also prompts users to answer a daily check in question. Mobile sensing data are processed to provide an automated assessment of the user's functioning. Patients will be asked to use Vira for the duration of their intensive outpatient treatment. Patients' use of the Vira app is supported by practitioners, who can schedule just-in-time reminders (i.e., "nudges") to arrive in the user's phone at scheduled times to support their behavior change plan and DBT treatment. The Vira Platform therefore integrates mobile sensing, self-report assessment, and just-in-time nudges and notifications into the practitioner's workflow.

BEHAVIORALTreatment as Usual (TAU)

Intensive outpatient DBT + EARS app (passive data monitoring software)

Locations(1)

Columbia University

New York, New York, United States

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NCT05920252

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

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(1)

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