Trial Outcomes & Findings for Mobile Technology for Reducing and Preventing Adolescent Suicide (NCT NCT04896593)

Last Updated: 2023-03-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

1 week post discharge

Results posted on

2023-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills.
Overall Study STARTED	22
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills.
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	1
Overall Study Did not complete onboarding	2

Baseline Characteristics

2 participants consented but dropped from the study prior to receiving the intervention (app). They were not included in the outcome analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=22 Participants Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills.
Age, Continuous	14.8182 years STANDARD_DEVIATION 1.2587 • n=22 Participants
Sex/Gender, Customized Gender · Female	16 Participants n=22 Participants
Sex/Gender, Customized Gender · Trans male	2 Participants n=22 Participants
Sex/Gender, Customized Gender · Nonbinary/Genderfluid	4 Participants n=22 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=22 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=22 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=22 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=22 Participants
Race (NIH/OMB) Asian	0 Participants n=22 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=22 Participants
Race (NIH/OMB) Black or African American	3 Participants n=22 Participants
Race (NIH/OMB) White	12 Participants n=22 Participants
Race (NIH/OMB) More than one race	1 Participants n=22 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=22 Participants
Baseline SIQ	54.700 units on a scale STANDARD_DEVIATION 18.966 • n=20 Participants • 2 participants consented but dropped from the study prior to receiving the intervention (app). They were not included in the outcome analysis.

PRIMARY outcome

Timeframe: 1 week post discharge

Outcome measures

Outcome measures
Measure	Intervention n=19 Participants Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills.
App Usability 1 Week	83.948 score on a scale Standard Deviation 10.046

PRIMARY outcome

Timeframe: 4 weeks post discharge

Outcome measures

Outcome measures
Measure	Intervention n=16 Participants Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills.
App Usability 4 Weeks	86.875 score on a scale Standard Deviation 9.060

PRIMARY outcome

Timeframe: 8 weeks post discharge

Outcome measures

Outcome measures
Measure	Intervention n=15 Participants Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills.
App Usability 8 Weeks	85.500 score on a scale Standard Deviation 9.171

PRIMARY outcome

Timeframe: 12 weeks post discharge

Outcome measures

Outcome measures
Measure	Intervention n=15 Participants Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills.
App Usability 12 Weeks	86.833 score on a scale Standard Deviation 10.457

PRIMARY outcome

Timeframe: 16 weeks post discharge

Outcome measures

Outcome measures
Measure	Intervention n=16 Participants Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills.
App Usability 16 Weeks	85.625 score on a scale Standard Deviation 8.827

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=20 Participants Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills.
Suicidal Ideation Baseline	54.700 score on a scale Standard Deviation 18.966

SECONDARY outcome

Timeframe: 1 Week post discharge

Outcome measures

Outcome measures
Measure	Intervention n=19 Participants Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills.
Suicidal Ideation 1 Week	43.421 score on a scale Standard Deviation 12.048

SECONDARY outcome

Timeframe: 4 Weeks post discharge

Outcome measures

Outcome measures
Measure	Intervention n=16 Participants Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills.
Suicidal Ideation 4 Weeks	27.125 score on a scale Standard Deviation 15.165

SECONDARY outcome

Timeframe: 8 Weeks post discharge

Outcome measures

Outcome measures
Measure	Intervention n=15 Participants Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills.
Suicidal Ideation 8 Weeks	25.200 score on a scale Standard Deviation 18.033

SECONDARY outcome

Timeframe: 12 Weeks post discharge

Outcome measures

Outcome measures
Measure	Intervention n=15 Participants Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills.
Suicidal Ideation 12 Weeks	26.867 score on a scale Standard Deviation 19.375

SECONDARY outcome

Timeframe: 16 Weeks post discharge

Outcome measures

Outcome measures
Measure	Intervention n=16 Participants Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills.
Suicidal Ideation 16 Weeks	26.625 score on a scale Standard Deviation 16.045

Adverse Events

Intervention

Serious events: 9 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intervention n=22 participants at risk Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills.
Psychiatric disorders Suicide attempt	18.2% 4/22 • Number of events 4 • From study enrollment through 16 weeks post-discharge assessment.
Psychiatric disorders Inpatient hospitalization	22.7% 5/22 • Number of events 7 • From study enrollment through 16 weeks post-discharge assessment.

Other adverse events

Other adverse events
Measure	Intervention n=22 participants at risk Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills.
General disorders Headaches	4.5% 1/22 • Number of events 1 • From study enrollment through 16 weeks post-discharge assessment.
Psychiatric disorders Increase in anger	4.5% 1/22 • Number of events 1 • From study enrollment through 16 weeks post-discharge assessment.
Psychiatric disorders Increase in SIQ-Jr total score above threshold	13.6% 3/22 • Number of events 3 • From study enrollment through 16 weeks post-discharge assessment.
Psychiatric disorders Increased fatigue in swimming	4.5% 1/22 • Number of events 1 • From study enrollment through 16 weeks post-discharge assessment.
General disorders Sinus issue	4.5% 1/22 • Number of events 1 • From study enrollment through 16 weeks post-discharge assessment.
Psychiatric disorders Feeling more down	4.5% 1/22 • Number of events 1 • From study enrollment through 16 weeks post-discharge assessment.
General disorders Weight gain	4.5% 1/22 • Number of events 1 • From study enrollment through 16 weeks post-discharge assessment.
Psychiatric disorders Medication side effects	4.5% 1/22 • Number of events 1 • From study enrollment through 16 weeks post-discharge assessment.
Psychiatric disorders Increased mania	4.5% 1/22 • Number of events 1 • From study enrollment through 16 weeks post-discharge assessment.
Social circumstances Sexual assault	4.5% 1/22 • Number of events 1 • From study enrollment through 16 weeks post-discharge assessment.
Psychiatric disorders Thoughts of self-harm	9.1% 2/22 • Number of events 2 • From study enrollment through 16 weeks post-discharge assessment.
General disorders ER and Urgent Care visits for migraines and vomiting.	4.5% 1/22 • Number of events 1 • From study enrollment through 16 weeks post-discharge assessment.
General disorders ER visit for dizziness and not eating or drinking	4.5% 1/22 • Number of events 1 • From study enrollment through 16 weeks post-discharge assessment.
General disorders COVID-19+	4.5% 1/22 • Number of events 1 • From study enrollment through 16 weeks post-discharge assessment.
General disorders ER visit for vomiting	4.5% 1/22 • Number of events 1 • From study enrollment through 16 weeks post-discharge assessment.
Psychiatric disorders Increased stress, DCF involvement	4.5% 1/22 • Number of events 1 • From study enrollment through 16 weeks post-discharge assessment.
Immune system disorders ER visit due to allergic reaction	4.5% 1/22 • Number of events 1 • From study enrollment through 16 weeks post-discharge assessment.
Infections and infestations Viral respiratory infection	4.5% 1/22 • Number of events 1 • From study enrollment through 16 weeks post-discharge assessment.
Psychiatric disorders Passive suicidal ideation, feeling more down	4.5% 1/22 • Number of events 1 • From study enrollment through 16 weeks post-discharge assessment.
Psychiatric disorders ER visit for suicidal ideation	4.5% 1/22 • Number of events 5 • From study enrollment through 16 weeks post-discharge assessment.

Additional Information

David Tolin, Ph.D.

Anxiety Disorders Center

Phone: 860-545-7685

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The principal investigator was designated by the sponsor to be the party responsible for conducting the trial and has the right to publish the results of the trial with approval from the sponsor.
Publication restrictions are in place

Restriction type: OTHER