Mobile Technology for Reducing and Preventing Adolescent Suicide

Suicidal Ideation Clinical Trial

Official title:

Mobile Technology for Reducing and Preventing Adolescent Suicide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04896593
• Other study ID #: HHC-2020-0363
• Secondary ID: R43MH125691
• Status: Completed
• Phase: N/A
• Start date: July 12, 2021
• Est. completion date: May 25, 2022

Study information

• Verified date: March 2023
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 25, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• Smartphone App
Smartphone app teaching suicide prevention skills.

Locations

Country	Name	City	State
United States	Institute of Living/Hartford Hospital	Hartford	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Hartford Hospital	National Institute of Mental Health (NIMH), Oui Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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