Clinical trial NCT04896593: Mobile Technology for Reducing and Preventing Adolescent Suicide
Official title: Mobile Technology for Reducing and Preventing Adolescent Suicide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide, Attempted
Suicidal Ideation
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: Oui Therapeutics, Inc.
name: National Institute of Mental Health (NIMH)
First posted: 2021-05-21
Enrollment: 22
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: App Usability 1 Week
timeFrame: 1 week post discharge
measure: App Usability 4 Weeks
timeFrame: 4 weeks post discharge
measure: App Usability 8 Weeks
timeFrame: 8 weeks post discharge
measure: App Usability 12 Weeks
timeFrame: 12 weeks post discharge
measure: App Usability 16 Weeks
timeFrame: 16 weeks post discharge
Secondary outcomes:
measure: Suicidal Ideation Baseline
timeFrame: Baseline
measure: Suicidal Ideation 1 Week
timeFrame: 1 Week post discharge
measure: Suicidal Ideation 4 Weeks
timeFrame: 4 Weeks post discharge
measure: Suicidal Ideation 8 Weeks
timeFrame: 8 Weeks post discharge
measure: Suicidal Ideation 12 Weeks
timeFrame: 12 Weeks post discharge
measure: Suicidal Ideation 16 Weeks
timeFrame: 16 Weeks post discharge
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Institute of Living/Hartford Hospital
state: Connecticut
Study officials:
affiliation: Institute of Living/Hartford Hospital
name: David Tolin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: