A Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vira, Treatment as Usual (TAU).
- Who it may be relevant to
- Registry conditions: Suicide, Mental Health Disorder, Anhedonia. Basic parameters: 13 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Testing of a Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide
Overview
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.
Detailed description
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. Specifically, it will conduct a pragmatic randomized controlled trial (RCT) based at the intensive outpatient services (Intensive Adolescent and Family DBT Program (Columbia Doctors)) to test the impact of using the Vira platform for patients versus treatment as usual control (TAU; i.e., not using Vira). This project will include adolescent patients (n = 200) aged 13-18-years-old randomized to: (a) Vira group (n = 100) and (b) treatment as usual control group (n = 100). Participants will include current patients receiving treatment in the intensive outpatient program, and all treatment decisions will be overseen by practitioners within the program. The overarching goal is to test whether using the Vira platform in the context of an intensive outpatient setting improves clinical outcomes.
Interventions
- Behavioral Vira
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 - Behavioral Treatment as Usual (TAU)
Intensive outpatient DBT + EARS app (passive data monitoring software)
Primary outcome measures
- Columbia Suicide Severity Rating Scale (C-SSRS) [Time frame: 6 months]
- Scale for Suicidal Ideation (SSI) [Time frame: 6 months]
Secondary outcome measures (5)
- Screen for Anxiety Related Emotional Disorders (SCARED) [Time frame: 3 and 6 months]
- Risky Behavior Questionnaire for Adolescents (RBQ-A) [Time frame: 3 and 6 months]
- Pittsburgh Sleep Quality Index (PSQI) [Time frame: 3 and 6 months]
- Mood and Feelings Questionnaire (MFQ) [Time frame: 3 and 6 months]
- Anticipatory & Consummatory Interpersonal Pleasure Scale (ACIPS) [Time frame: 3 and 6 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Columbia University — New York
Identifiers
NCT: NCT05920252 · OV-002 · R44MH128484 · AAAV0626