Suicidal Ideation, Suicide, Attempted
Conditions
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
Smartphone app teaching suicide prevention skills.
Sponsors
Study design
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| App Usability 1 Week | 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. |
| App Usability 4 Weeks | 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. |
| App Usability 8 Weeks | 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. |
| App Usability 12 Weeks | 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. |
| App Usability 16 Weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Suicidal Ideation Baseline | 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. |
| Suicidal Ideation 16 Weeks | 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. |
| Suicidal Ideation 1 Week | 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. |
| Suicidal Ideation 4 Weeks | 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. |
| Suicidal Ideation 8 Weeks | 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. |
| Suicidal Ideation 12 Weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Smartphone app teaching suicide prevention skills.
Smartphone App: Smartphone app teaching suicide prevention skills. | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not complete onboarding | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 14.8182 years STANDARD_DEVIATION 1.2587 |
| Baseline SIQ | 54.700 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 type | EG000 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
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | App Usability 12 Weeks | 86.833 score on a scale | Standard Deviation 10.457 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | App Usability 16 Weeks | 85.625 score on a scale | Standard Deviation 8.827 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | App Usability 1 Week | 83.948 score on a scale | Standard Deviation 10.046 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | App Usability 4 Weeks | 86.875 score on a scale | Standard Deviation 9.06 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | App Usability 8 Weeks | 85.500 score on a scale | Standard Deviation 9.171 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Suicidal Ideation 12 Weeks | 26.867 score on a scale | Standard Deviation 19.375 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Suicidal Ideation 16 Weeks | 26.625 score on a scale | Standard Deviation 16.045 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Suicidal Ideation 1 Week | 43.421 score on a scale | Standard Deviation 12.048 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Suicidal Ideation 4 Weeks | 27.125 score on a scale | Standard Deviation 15.165 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Suicidal Ideation 8 Weeks | 25.200 score on a scale | Standard Deviation 18.033 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Suicidal Ideation Baseline | 54.700 score on a scale | Standard Deviation 18.966 |