Mobile Technology for Reducing and Preventing Adolescent Suicide

Sponsor
Hartford Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04896593
Collaborator
Oui Therapeutics, LLC (Industry), National Institute of Mental Health (NIMH) (NIH)
20
1
1
10.6
1.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Smartphone App
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Mobile Technology for Reducing and Preventing Adolescent Suicide
Actual Study Start Date :
Jul 12, 2021
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Smartphone app teaching suicide prevention skills.

Behavioral: Smartphone App
Smartphone app teaching suicide prevention skills.

Outcome Measures

Primary Outcome Measures

  1. 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. The mean and standard deviation for the SUS will be reported utilizing all available data.

  2. 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. The mean and standard deviation for the SUS will be reported utilizing all available data.

  3. 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. The mean and standard deviation for the SUS will be reported utilizing all available data.

  4. 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. The mean and standard deviation for the SUS will be reported utilizing all available data.

  5. 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. The mean and standard deviation for the SUS will be reported utilizing all available data.

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Suicidal Ideation 116 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 17 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Living/Hartford Hospital Hartford Connecticut United States 06106

Sponsors and Collaborators

  • Hartford Hospital
  • Oui Therapeutics, LLC
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: David Tolin, Ph.D., Institute of Living/Hartford Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT04896593
Other Study ID Numbers:
  • HHC-2020-0363
  • R43MH125691
First Posted:
May 21, 2021
Last Update Posted:
May 3, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2022