Mobile Technology for Reducing and Preventing Adolescent Suicide

Study Overview
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Brief Summary
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This single-group open-label trial will evaluate the feasibility and preliminary efficacy of a suicide prevention mobile application when used as an adjunct to usual care in adolescents.

Detailed Description
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This study will enroll 20 adolescent (age 13-17) inpatients at elevated risk for suicide. Participants will download the app onto their phones during their inpatient stay and will complete a single therapy session involving psychoeducation and crisis response planning. Participants will be encouraged to use the app on their own in addition to their usual outpatient services to learn and practice suicide prevention skills. Participants and their parents will be interviewed 1, 4, 8, 12, and 16 weeks after discharge.

Official Title
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Mobile Technology for Reducing and Preventing Adolescent Suicide

Conditions
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Suicide, Attempted, Suicidal Ideation

Intervention / Treatment
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* Behavioral: Smartphone App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatient psychiatric patients who have attempted suicide (lifetime) or have documented suicide ideation and a plan to harm themselves at admission Understand written and spoken English Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher Willing and able to complete enrollment procedures Parent/guardian (and youth) able to understand the nature of the study and provide written informed consent (assent for youth) Willing to agree to release of information to their parent/guardian and providers when clinically indicated. Discharge plan includes aftercare within the Hartford HealthCare system (to facilitate coordination of care during follow up) Exclusion Criteria: Patients with active psychosis Patients experiencing substance withdrawal Currently enrolled in other treatment studies for the symptoms and behaviors targeted Patient unwilling or unable to wear mask during in-person study procedures Patients who, in the judgment of the investigator, would have an unfavorable risk/benefit profile with respect to the Smartphone App. Any other psychiatric or medical condition (e.g., intellectual disability) or custody arrangement that in the investigator's opinion would preclude informed consent/assent or participation in the trial.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Smartphone app teaching suicide prevention skills. | Behavioral: Smartphone App<br>* Smartphone app teaching suicide prevention skills.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| App Usability 1 Week | The System Usability Scale (SUS) contains 10 items assessing the usability of digital technology. Items are rated from 1 to 5 with higher numbers representing stronger agreement with usability statements. Scores can range from 0 to 100, with higher scores reflecting better outcomes, meaning increased usability of the technology. The mean and standard deviation for the SUS will be reported utilizing all available data. | 1 week post discharge | 
| App Usability 4 Weeks | The System Usability Scale (SUS) contains 10 items assessing the usability of digital technology. Items are rated from 1 to 5 with higher numbers representing stronger agreement with usability statements. Scores can range from 0 to 100, with higher scores reflecting better outcomes, meaning increased usability of the technology. The mean and standard deviation for the SUS will be reported utilizing all available data. | 4 weeks post discharge | 
| App Usability 8 Weeks | The System Usability Scale (SUS) contains 10 items assessing the usability of digital technology. Items are rated from 1 to 5 with higher numbers representing stronger agreement with usability statements. Scores can range from 0 to 100, with higher scores reflecting better outcomes, meaning increased usability of the technology. The mean and standard deviation for the SUS will be reported utilizing all available data. | 8 weeks post discharge | 
| App Usability 12 Weeks | The System Usability Scale (SUS) contains 10 items assessing the usability of digital technology. Items are rated from 1 to 5 with higher numbers representing stronger agreement with usability statements. Scores can range from 0 to 100, with higher scores reflecting better outcomes, meaning increased usability of the technology. The mean and standard deviation for the SUS will be reported utilizing all available data. | 12 weeks post discharge | 
| App Usability 16 Weeks | The System Usability Scale (SUS) contains 10 items assessing the usability of digital technology. Items are rated from 1 to 5 with higher numbers representing stronger agreement with usability statements. Scores can range from 0 to 100, with higher scores reflecting better outcomes, meaning increased usability of the technology. The mean and standard deviation for the SUS will be reported utilizing all available data. | 16 weeks post discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicidal Ideation Baseline | The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data. | Baseline | 
| Suicidal Ideation 1 Week | The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data. | 1 Week post discharge | 
| Suicidal Ideation 4 Weeks | The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data. | 4 Weeks post discharge | 
| Suicidal Ideation 8 Weeks | The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data. | 8 Weeks post discharge | 
| Suicidal Ideation 12 Weeks | The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data. | 12 Weeks post discharge | 
| Suicidal Ideation 16 Weeks | The SIQ Jr is a 15-item measure assesses suicidal thoughts on a 7-point scale, with possible total scores ranging from 0-90). Higher scores indicate more severe suicidal ideation. Means and standard deviations will be reported utilizing all available data. | 16 Weeks post discharge |