Mobile Technology for Reducing and Preventing Adolescent Suicide

NCT ID: NCT04896593

Last Updated: 2023-03-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-12

Study Completion Date

2022-05-25

Brief Summary

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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

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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

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Suicide, Attempted Suicidal Ideation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Smartphone app teaching suicide prevention skills.

Group Type EXPERIMENTAL

Smartphone App

Intervention Type BEHAVIORAL

Smartphone app teaching suicide prevention skills.

Interventions

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Smartphone App

Smartphone app teaching suicide prevention skills.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oui Therapeutics, Inc.

INDUSTRY

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Hartford Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Tolin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Institute of Living/Hartford Hospital

Locations

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Institute of Living/Hartford Hospital

Hartford, Connecticut, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R43MH125691

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HHC-2020-0363

Identifier Type: -

Identifier Source: org_study_id

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