NCT04896593

Mobile Technology for Reducing and Preventing Adolescent Suicide

Completed NA Results posted Last updated 30 March 2023

What this trial tests

NA trial testing Smartphone App in Suicide, Attempted in 22 participants. Completed in 25 May 2022.

Timeline

12 July 2021

Primary endpoint
25 May 2022

25 May 2022

Quick facts

Lead sponsor	Hartford Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	12 July 2021
Primary completion	25 May 2022
Estimated completion	25 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Smartphone App

Conditions studied

• Suicide, Attempted — all drugs for Suicide, Attempted →
• Suicidal Ideation — all drugs for Suicidal Ideation →

Sponsor

Hartford Hospital

Who can join

Adults 13 to 17, any sex, with Suicide, Attempted or Suicidal Ideation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

App Usability 1 Week Primary · 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.

Group	Value	95% CI
Intervention	83.948	± 10.046

App Usability 4 Weeks Primary · 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.

Group	Value	95% CI
Intervention	86.875	± 9.060

App Usability 8 Weeks Primary · 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.

Group	Value	95% CI
Intervention	85.500	± 9.171

App Usability 12 Weeks Primary · 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.

Group	Value	95% CI
Intervention	86.833	± 10.457

App Usability 16 Weeks Primary · 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.

Group	Value	95% CI
Intervention	85.625	± 8.827

Suicidal Ideation Baseline Secondary · 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.

Group	Value	95% CI
Intervention	54.700	± 18.966

Suicidal Ideation 1 Week Secondary · 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.

Group	Value	95% CI
Intervention	43.421	± 12.048

Suicidal Ideation 4 Weeks Secondary · 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.

Group	Value	95% CI
Intervention	27.125	± 15.165

Suicidal Ideation 8 Weeks Secondary · 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.

Group	Value	95% CI
Intervention	25.200	± 18.033

Suicidal Ideation 12 Weeks Secondary · 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.

Group	Value	95% CI
Intervention	26.867	± 19.375

Suicidal Ideation 16 Weeks Secondary · 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.

Group	Value	95% CI
Intervention	26.625	± 16.045

Adverse events — posted to ClinicalTrials.gov

Time frame: From study enrollment through 16 weeks post-discharge assessment.. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention

Serious: 9/22 (41%)

Deaths: 0/22

Serious adverse events (2 terms)

Reaction	System	Intervention
Inpatient hospitalization	Psychiatric disorders	—
Suicide attempt	Psychiatric disorders	—

Other adverse events (20 terms — click to expand)

Reaction	System	Intervention
Increase in SIQ-Jr total score above threshold	Psychiatric disorders	—
Thoughts of self-harm	Psychiatric disorders	—
Headaches	General disorders	—
Increase in anger	Psychiatric disorders	—
Increased fatigue in swimming	Psychiatric disorders	—
Sinus issue	General disorders	—
Feeling more down	Psychiatric disorders	—
Weight gain	General disorders	—
Medication side effects	Psychiatric disorders	—
Increased mania	Psychiatric disorders	—
Sexual assault	Social circumstances	—
ER and Urgent Care visits for migraines and vomiting.	General disorders	—
ER visit for dizziness and not eating or drinking	General disorders	—
COVID-19+	General disorders	—
ER visit for vomiting	General disorders	—
Increased stress, DCF involvement	Psychiatric disorders	—
ER visit due to allergic reaction	Immune system disorders	—
Viral respiratory infection	Infections and infestations	—
Passive suicidal ideation, feeling more down	Psychiatric disorders	—
ER visit for suicidal ideation	Psychiatric disorders	—

Most-reported serious reactions: Inpatient hospitalization, Suicide attempt.

Data from ClinicalTrials.gov NCT04896593 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.