Clinical trial NCT05920252: A Digitally Assisted Risk Reduction Platform for Youth At High Risk for Suicide
Official title: Development and Testing of a Digitally Assisted Risk Reduction Platform for Youth At High Risk for Suicide
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide
Mental Health Disorder
Anhedonia
Keywords: Depression
Depressive Disorder
Mood Disorders
Mental Disorders
Suicidal Behaviors
Suicidal Thoughts
Suicidal Ideation
Lead sponsor: Ksana Health
Sponsor class: INDUSTRY
Collaborators: name: Columbia University
name: National Institute of Mental Health (NIMH)
First posted: 2023-06-27
Enrollment: 200
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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, we 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. Specifically, we 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.

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

Primary outcomes:
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 6 months
measure: Scale for Suicidal Ideation (SSI)
timeFrame: 6 months
Secondary outcomes:
measure: Screen for Anxiety Related Emotional Disorders (SCARED)
timeFrame: 3 and 6 months
measure: Risky Behavior Questionnaire for Adolescents (RBQ-A)
timeFrame: 3 and 6 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 3 and 6 months
measure: Mood and Feelings Questionnaire (MFQ)
timeFrame: 3 and 6 months
measure: Anticipatory & Consummatory Interpersonal Pleasure Scale (ACIPS)
timeFrame: 3 and 6 months
Other outcomes:
measure: System Usability Scale (SUS)
timeFrame: 3 and 6 months
measure: Interpersonal Needs Questionnaire (INQ)
timeFrame: 3 and 6 months
measure: National Institute of Drug Abuse (NIDA) Quick Screen V1.0
timeFrame: 3 and 6 months
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Ksana Health
name: Nick Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References: