Mobile Technology for Reducing and Preventing Adolescent Suicide

NCT04896593 | Completed Results

• 2 other identifiers: HHC-2020-0363R43MH125691
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide, Attempted; Suicidal Ideation

Outcome Measures

Primary Outcomes (5)

• 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

• 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

Secondary Outcomes (6)

• Suicidal Ideation Baseline

  Baseline

• Suicidal Ideation 1 Week

  1 Week post discharge

• Suicidal Ideation 4 Weeks

  4 Weeks post discharge

• Suicidal Ideation 8 Weeks

  8 Weeks post discharge

• Suicidal Ideation 12 Weeks

  12 Weeks post discharge

Study Arms (1)

Intervention

EXPERIMENTAL

Smartphone app teaching suicide prevention skills.

Behavioral: Smartphone App

Interventions

Smartphone App BEHAVIORAL

Smartphone app teaching suicide prevention skills.

Intervention

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hartford Hospital: lead
• Oui Therapeutics, Inc.: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Institute of Living/Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Suicide, Attempted; Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: David Tolin, Ph.D.
• Organization: Anxiety Disorders Center

david.tolin@hhchealth.org

860-545-7685

Study Officials

• David Tolin, Ph.D.

  Institute of Living/Hartford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 21, 2021
• Study Start: July 12, 2021
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: March 30, 2023
• Results First Posted: March 30, 2023

Record last verified: 2023-03

Locations

US (1)