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Clinical Trials/NCT04896593
NCT04896593
Completed
Not Applicable

Mobile Technology for Reducing and Preventing Adolescent Suicide

Hartford Hospital1 site in 1 country22 target enrollmentJuly 12, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicide, Attempted
Sponsor
Hartford Hospital
Enrollment
22
Locations
1
Primary Endpoint
App Usability 1 Week
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
July 12, 2021
End Date
May 25, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

App Usability 1 Week

Time Frame: 1 week post discharge

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.

App Usability 4 Weeks

Time Frame: 4 weeks post discharge

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.

App Usability 16 Weeks

Time Frame: 16 weeks post discharge

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.

App Usability 8 Weeks

Time Frame: 8 weeks post discharge

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.

App Usability 12 Weeks

Time Frame: 12 weeks post discharge

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.

Secondary Outcomes

  • Suicidal Ideation 1 Week(1 Week post discharge)
  • Suicidal Ideation Baseline(Baseline)
  • Suicidal Ideation 12 Weeks(12 Weeks post discharge)
  • Suicidal Ideation 4 Weeks(4 Weeks post discharge)
  • Suicidal Ideation 8 Weeks(8 Weeks post discharge)
  • Suicidal Ideation 16 Weeks(16 Weeks post discharge)

Study Sites (1)

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