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Mobile Technology for Reducing and Preventing Adolescent Suicide

Mobile Technology for Reducing and Preventing Adolescent Suicide

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04896593
Enrollment
22
Registered
2021-05-21
Start date
2021-07-12
Completion date
2022-05-25
Last updated
2023-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicidal Ideation, Suicide, Attempted

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.

Interventions

BEHAVIORALSmartphone App

Smartphone app teaching suicide prevention skills.

Sponsors

Oui Therapeutics, Inc.
CollaboratorINDUSTRY
National Institute of Mental Health (NIMH)
CollaboratorNIH
Hartford Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
App Usability 1 Week1 week post dischargeThe 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 Weeks4 weeks post dischargeThe 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 Weeks8 weeks post dischargeThe 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 Weeks12 weeks post dischargeThe 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 Weeks16 weeks post dischargeThe 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

MeasureTime frameDescription
Suicidal Ideation BaselineBaselineThe 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.
Suicidal Ideation 16 Weeks16 Weeks post dischargeThe 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.
Suicidal Ideation 1 Week1 Week post dischargeThe 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.
Suicidal Ideation 4 Weeks4 Weeks post dischargeThe 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.
Suicidal Ideation 8 Weeks8 Weeks post dischargeThe 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.
Suicidal Ideation 12 Weeks12 Weeks post dischargeThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention
Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills.
22
Total22

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDid not complete onboarding2
Overall StudyLost to Follow-up1
Overall StudyWithdrawal by Subject2

Baseline characteristics

CharacteristicIntervention
Age, Continuous14.8182 years
STANDARD_DEVIATION 1.2587
Baseline SIQ54.700 units on a scale
STANDARD_DEVIATION 18.966
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants
Race (NIH/OMB)
White
12 Participants
Sex/Gender, Customized
Gender
Female
16 Participants
Sex/Gender, Customized
Gender
Nonbinary/Genderfluid
4 Participants
Sex/Gender, Customized
Gender
Trans male
2 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 22
other
Total, other adverse events
19 / 22
serious
Total, serious adverse events
9 / 22

Outcome results

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.

Time frame: 12 weeks post discharge

ArmMeasureValue (MEAN)Dispersion
InterventionApp Usability 12 Weeks86.833 score on a scaleStandard Deviation 10.457
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.

Time frame: 16 weeks post discharge

ArmMeasureValue (MEAN)Dispersion
InterventionApp Usability 16 Weeks85.625 score on a scaleStandard Deviation 8.827
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.

Time frame: 1 week post discharge

ArmMeasureValue (MEAN)Dispersion
InterventionApp Usability 1 Week83.948 score on a scaleStandard Deviation 10.046
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.

Time frame: 4 weeks post discharge

ArmMeasureValue (MEAN)Dispersion
InterventionApp Usability 4 Weeks86.875 score on a scaleStandard Deviation 9.06
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.

Time frame: 8 weeks post discharge

ArmMeasureValue (MEAN)Dispersion
InterventionApp Usability 8 Weeks85.500 score on a scaleStandard Deviation 9.171
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.

Time frame: 12 Weeks post discharge

ArmMeasureValue (MEAN)Dispersion
InterventionSuicidal Ideation 12 Weeks26.867 score on a scaleStandard Deviation 19.375
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.

Time frame: 16 Weeks post discharge

ArmMeasureValue (MEAN)Dispersion
InterventionSuicidal Ideation 16 Weeks26.625 score on a scaleStandard Deviation 16.045
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.

Time frame: 1 Week post discharge

ArmMeasureValue (MEAN)Dispersion
InterventionSuicidal Ideation 1 Week43.421 score on a scaleStandard Deviation 12.048
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.

Time frame: 4 Weeks post discharge

ArmMeasureValue (MEAN)Dispersion
InterventionSuicidal Ideation 4 Weeks27.125 score on a scaleStandard Deviation 15.165
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.

Time frame: 8 Weeks post discharge

ArmMeasureValue (MEAN)Dispersion
InterventionSuicidal Ideation 8 Weeks25.200 score on a scaleStandard Deviation 18.033
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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
InterventionSuicidal Ideation Baseline54.700 score on a scaleStandard Deviation 18.966

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026