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| ID | Type | Description | Link |
|---|---|---|---|
| R43MH125691 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Oui Therapeutics, Inc. | INDUSTRY |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Smartphone app teaching suicide prevention skills. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone App | Behavioral | Smartphone app teaching suicide prevention skills. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Suicidal Ideation 1 Week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Tolin, Ph.D. | Institute of Living/Hartford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Living/Hartford Hospital | Hartford | Connecticut | 06106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 1 week post discharge |
|
|
From study enrollment through 16 weeks post-discharge assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Smartphone app teaching suicide prevention skills. Smartphone App: Smartphone app teaching suicide prevention skills. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headaches | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Tolin, Ph.D. | Anxiety Disorders Center | 860-545-7685 | david.tolin@hhchealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2022 | Mar 27, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 14, 2020 | Mar 27, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 24, 2021 | Dec 6, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D013406 | Suicide, Attempted |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 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 |
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline SIQ | 2 participants consented but dropped from the study prior to receiving the intervention (app). They were not included in the outcome analysis. | Mean | Standard Deviation | units on a scale |
|
| Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 16 Weeks post discharge |
|
|
|
| 0 |
| 22 |
| 9 |
| 22 |
| 19 |
| 22 |
| Inpatient hospitalization | Psychiatric disorders | Systematic Assessment |
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| Increase in anger | Psychiatric disorders | Systematic Assessment |
|
| Increase in SIQ-Jr total score above threshold | Psychiatric disorders | Systematic Assessment | Increase in SIQ-Jr total score above reliable change threshold |
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| Increased fatigue in swimming | Psychiatric disorders | Systematic Assessment |
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| Sinus issue | General disorders | Systematic Assessment |
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| Feeling more down | Psychiatric disorders | Systematic Assessment | Feeling more down due to increased swim and school demands |
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| Weight gain | General disorders | Systematic Assessment | 10lb weight gain at the end of swim season |
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| Medication side effects | Psychiatric disorders | Systematic Assessment | Side effects after stopped taking psychiatric medications |
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| Increased mania | Psychiatric disorders | Systematic Assessment | Increased mania, frequently leaving house against parental wishes, discontinued psychiatric medications |
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| Sexual assault | Social circumstances | Systematic Assessment | Reported sexual assault to police and study IE |
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| Thoughts of self-harm | Psychiatric disorders | Systematic Assessment |
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| ER and Urgent Care visits for migraines and vomiting. | General disorders | Systematic Assessment | Increased migraines and anxiety, vomiting due to migraines. Having hard time going to school and seeing friends. Went to the ER 3 times and Urgent Care 2 times, not admitted to hospital due to migraines/vomiting |
|
| ER visit for dizziness and not eating or drinking | General disorders | Systematic Assessment | Transferred from psychiatric inpatient to ER for dizziness and not eating or drinking |
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| COVID-19+ | General disorders | Systematic Assessment |
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| ER visit for vomiting | General disorders | Systematic Assessment |
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| Increased stress, DCF involvement | Psychiatric disorders | Systematic Assessment | Increased stress, patient escorted home after spending the night outside of the home. DCF involved afterwards. |
|
| ER visit due to allergic reaction | Immune system disorders | Systematic Assessment | Accidental ingestion of nuts (has severe nut allergy), used epi pen. Went to ER and given steroid and Pepcid before discharged. No hospitalization. |
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| Viral respiratory infection | Infections and infestations | Systematic Assessment | Not COVID/strep |
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| Passive suicidal ideation, feeling more down | Psychiatric disorders | Systematic Assessment |
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| ER visit for suicidal ideation | Psychiatric disorders | Systematic Assessment |
|
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.