Establishing Efficacy of an Inpatient Intervention and Phone App to Reduce Suicidal Risk

University of Texas Southwestern Medical Center241 enrolled

Overview

In this 2-site study, University of Texas Southwestern Medical Center (UTSW) and Western Psychiatric Institute and Clinic (WPIC), the investigators will conduct a randomized clinical trial (RCT) in 240 psychiatrically hospitalized suicidal adolescents, examining the single and additive effects of two components of an inpatient unit intervention for suicidal adolescents, As Safe As Possible (ASAP), which focuses on emotion regulation and safety planning, and an emotion regulation/safety plan phone app (BRITE).

The investigators aim to randomize 240 adolescents psychiatrically hospitalized for suicidal ideation with a plan or a suicide attempt to one of four treatment arms: (1) ASAP + BRITE + TAU (treatment as usual); (2) BRITE + TAU (treatment as usual); (3) ASAP + TAU (treatment as usual); and (4) TAU (treatment as usual) alone. The investigators will assess suicidal ideation and behavior at 4, 12, and 24 weeks post-intake, in order to: 1. Assess the relative efficacy of ASAP, BRITE and the combination on suicidal ideation, non-suicidal self-injury (NSSI), and suicide attempts, and re-hospitalizations. 2. Examine mediators and moderators of treatment outcome. 3. Examine the costs and cost efficacy of ASAP and BRITE and the combination.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

241

Conditions

Suicidal Ideation Suicide, Attempted

Interventions

ASAP (As Safe As Possible)BEHAVIORAL

ASAP (As Safe As Possible) is a brief intervention for adolescents hospitalized for suicide risk that focuses on the development of a safety plan, teaching emotion regulation and distress tolerance skills, along with 1-2 post-discharge follow-up calls to encourage adherence to use of the safety plan and to outpatient treatment.

BRITE smart phone appBEHAVIORAL

BRITE is a smart phone app that aims to support daily emotion regulation and a safety plan that is personalized to the needs and preferences of each adolescent.

TAU (treatment as usual)BEHAVIORAL

TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Youth admitted to the inpatient unit at either site for a recent suicide attempt or significant suicidal ideation with a plan or intent. * The youth and parent are able to complete assessments in English, and the youth is able to complete therapy. Exclusion Criteria: * The youth currently exhibits psychosis. * The youth currently exhibits mania. * The youth is currently \<85% of their ideal body weight. * The youth is intellectually incapable of completing the study, e.g. has an intelligence quotient (IQ) \< 70.

Outcomes

Primary Outcomes

Participants With Actual Suicide Attempts as Defined by Columbia Suicide Severity Rating Scale (C-SSRS)

Compare the 4 cells on the rate of actual suicide attempts and time to suicide attempt. Suicide attempt assessed with the Columbia Suicide Severity Rating Scale (C-SSRS)

Time frame: 1 - 24 weeks

Suicidal Events

Defined as actual, aborted, or interrupted attempt based on the the Columbia-Suicide Severity Rating Scale (C-SSRS), and or rehospitalization.

Time frame: 1 to 24 weeks