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Completed

NCT Number: NCT04896593

Mobile Technology for Reducing and Preventing Adolescent Suicide

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.

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Key information

Conditions

Suicide, Attempted Behavior Behavioral Symptoms Self-Injurious Behavior Suicidal Ideation Suicide

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Living/Hartford Hospital

Hartford, Connecticut, 06106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smartphone App

Behavioral

Smartphone app teaching suicide prevention skills.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Suicidal Ideation Baseline

    Time frame: 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.

  2. Suicidal Ideation 1 Week

    Time frame: 1 Week post discharge

    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.

  3. Suicidal Ideation 4 Weeks

    Time frame: 4 Weeks post discharge

    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. Suicidal Ideation 8 Weeks

    Time frame: 8 Weeks post discharge

    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.

  5. Suicidal Ideation 12 Weeks

    Time frame: 12 Weeks post discharge

    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.

  6. Suicidal Ideation 16 Weeks

    Time frame: 16 Weeks post discharge

    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.

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Oui Therapeutics, Inc.

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 21, 2021
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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