search
Back to results

Mobile Technology for Reducing and Preventing Adolescent Suicide

Primary Purpose

Suicide, Attempted, Suicidal Ideation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone App
Sponsored by
Hartford Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide, Attempted

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Living/Hartford Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Smartphone app teaching suicide prevention skills.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 14, 2021
Last Updated
March 29, 2023
Sponsor
Hartford Hospital
Collaborators
Oui Therapeutics, Inc., National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT04896593
Brief Title
Mobile Technology for Reducing and Preventing Adolescent Suicide
Official Title
Mobile Technology for Reducing and Preventing Adolescent Suicide
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 12, 2021 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
May 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital
Collaborators
Oui Therapeutics, Inc., National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted, Suicidal Ideation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Smartphone app teaching suicide prevention skills.
Intervention Type
Behavioral
Intervention Name(s)
Smartphone App
Intervention Description
Smartphone app teaching suicide prevention skills.
Primary Outcome Measure Information:
Title
App Usability 1 Week
Description
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
Title
App Usability 4 Weeks
Description
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
Title
App Usability 8 Weeks
Description
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
Title
App Usability 12 Weeks
Description
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
Title
App Usability 16 Weeks
Description
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
Secondary Outcome Measure Information:
Title
Suicidal Ideation Baseline
Description
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
Title
Suicidal Ideation 1 Week
Description
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
Title
Suicidal Ideation 4 Weeks
Description
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
Title
Suicidal Ideation 8 Weeks
Description
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
Title
Suicidal Ideation 12 Weeks
Description
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
Title
Suicidal Ideation 16 Weeks
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Tolin, Ph.D.
Organizational Affiliation
Institute of Living/Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Living/Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Mobile Technology for Reducing and Preventing Adolescent Suicide

We'll reach out to this number within 24 hrs