Suicide, AttemptedNCT04896593
Mobile Technology for Reducing and Preventing Adolescent Suicide
A study testing Smartphone App in people with Suicide, Attempted and Suicidal Ideation, run by Hartford Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Suicide, Attempted, Suicidal Ideation
- What is being tested?
- Smartphone App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2021to 25 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Living/Hartford Hospital
Hartford, Connecticut, 06106
About this study
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.
Read the 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.
- Conditions
- Suicide, Attempted, Suicidal Ideation
- Being tested
- Smartphone App
- Medical subject headings
- Suicide, Attempted, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone AppBehavioural
Smartphone app teaching suicide prevention skills.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Smartphone app teaching suicide prevention skills. Receives: Behavioral: Smartphone App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks post discharge
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.
Measured: 16 weeks post discharge
Secondary outcomes (6)
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.
Measured: Baseline
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 Weeks post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start12 Jul 2021
- Primary completion25 May 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oui Therapeutics, Inc., National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- David Tolin, Ph.D., Principal investigator, Institute of Living/Hartford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896593
- Sponsor's protocol ID
- HHC-2020-0363
- Other IDs
- R43MH125691
- Status last verified
- Mar 2023
- First submitted
- 14 May 2021
- Last updated
- 30 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Technology for Reducing and Preventing Adolescent Suicide
- ClinicalTrials.gov ID
- NCT04896593
- Acronym / sponsor ID
- HHC-2020-0363
- Conditions
- Suicide, Attempted, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- Oui Therapeutics, Inc., National Institute of Mental Health (NIMH)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Posted 30 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Smartphone AppSmartphone app teaching suicide prevention skills. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone AppSmartphone app teaching suicide prevention skills. | Behavioural | Intervention |
Primary outcome
App Usability 1 Week
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
6 secondary outcomes
Suicidal Ideation Baseline
Time frame: Baseline
Suicidal Ideation 1 Week
Time frame: 1 Week post discharge
Suicidal Ideation 4 Weeks
Time frame: 4 Weeks post discharge
Suicidal Ideation 8 Weeks
Time frame: 8 Weeks post discharge
Suicidal Ideation 12 Weeks
Time frame: 12 Weeks post discharge
Suicidal Ideation 16 Weeks
Time frame: 16 Weeks post discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Tolin, Ph.D. principal investigator
Institute of Living/Hartford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone App in people with Suicide, Attempted and Suicidal Ideation, run by Hartford Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
App Usability 1 Week (time frame: 1 week post discharge). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.