A Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorKsana Health
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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+)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Vira
BehavioralIntensive 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.
Treatment as Usual (TAU)
BehavioralIntensive outpatient DBT + EARS app (passive data monitoring software)
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Digitally enhanced treatment supported by the Vira platformExperimental treatment 1 intervention
Group B: Treatment as Usual (TAU)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Columbia Suicide Severity Rating Scale (C-SSRS)
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).
Time frame
6 months2
Scale for Suicidal Ideation (SSI)
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.
Time frame
6 monthsSecondary outcomes
1
Screen for Anxiety Related Emotional Disorders (SCARED)
The scared is a 5-item self-report questionnaire used to screen for childhood anxiety disorders including general anxiety disorder, separate anxiety disorder, panic disorder, and social phobia. Items are rated on a 3 point Likert scale from 0 to 2 and summed to yield a total score. Total scores range from 0 to 10. Higher scores indicate greater anxiety.
Time frame
3 and 6 months2
Risky Behavior Questionnaire for Adolescents (RBQ-A)
The RBQ-A is a 20-item self-report measure that assesses frequency of engagement of risky behaviors (e.g., sexual precociousness, aggression, rule-breaking, and substance use). Items are rated on a 5-point Likert scale. Scores range from 0 to 80. Higher scores reflect greater engagement in risky behaviors.
Time frame
3 and 6 months3
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 19-item self-report measure of sleep quality and disturbances. The 19 items are grouped into 7 component scores, each weighted equally on a 0 to 3 scale and summed to yield a global PSQI score. Total scores range from 0 to 21. Higher scores indicate worse sleep quality.
Time frame
3 and 6 months4
Mood and Feelings Questionnaire (MFQ)
The MFQ is a 13-item self-report questionnaire used to screen for depressive in children and young people. Items are rated on a 3-point Likert scale (not true = 0; sometimes true = 1; not true = 2). Scores are calculated by summing the point values on each response. Total MFQ scores range from 0 to 26, with higher scores suggesting greater severity in depressive symptoms.
Time frame
3 and 6 monthsOther outcomes
1
System Usability Scale (SUS)
The System Usability Scale is a 10-item measure that evaluates the usability of mobile software. Items are rated on a 5-point Likert scale from 0 to 4. Total SUS scores range from 0 to 100. Higher scores reflect greater usability.
Time frame
3 and 6 months2
Interpersonal Needs Questionnaire (INQ)
The INQ is a 15-item self-report assessment of interpersonal factors thought to be associated with suicidal desire and behaviors. Items are rated on a 7-point Likert scale. Scores range from 15 to 105. Higher scores reflect greater levels of these interpersonal factors.
Time frame
3 and 6 months3
National Institute of Drug Abuse (NIDA) Quick Screen V1.0
The NIDA Quick Screen is used to screen patients for drug use in general medical settings. The tool consists of 4 items regarding frequency of past year use of alcohol, tobacco, non-medical prescription drug, and illegal drug use.
Time frame
3 and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ksana Health
Lead sponsor
Columbia University
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov