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

Study Overview
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Brief Summary
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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).

Detailed Description
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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: Assess the relative efficacy of ASAP, BRITE and the combination on suicidal ideation, non-suicidal self-injury (NSSI), and suicide attempts, and re-hospitalizations. Examine mediators and moderators of treatment outcome. Examine the costs and cost efficacy of ASAP and BRITE and the combination.

Official Title
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As Safe As Possible (ASAP): A Balanced, Two-by-Two Design To Test Conjoint and Unique Efficacy of an Inpatient Intervention and an Emotion Regulation/Safety Planning App in Preventing Suicide Attempts Post-Discharge

Conditions
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Suicidal Ideation, Suicide, Attempted

Intervention / Treatment
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* Behavioral: ASAP (As Safe As Possible)
* Behavioral: BRITE smart phone app
* Behavioral: TAU (treatment as usual)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Investigators will randomize 240 hospitalized suicidal adolescents with a history of a suicide attempt or ideation with plan to one of 4 conditions in a 2 by 2 design: (1) ASAP + BRITE; (2) BRITE + TAU (treatment as usual); (3) ASAP + TAU; or (4) TAU alone to determine the single and additive effects of ASAP and BRITE on suicide attempts in the subsequent six months.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASAP + BRITE + TAU (treatment as usual)<br>Participants in this arm receive the ASAP (As Safe As Possible) intervention, during their transition from inpatient to outpatient care, as well as the BRITE smart phone app for distress tolerance/emotion regulation and safety planning. Participants will also receive usual treatment protocols that all adolescents admitted to their respective Inpatient Psychiatry program receive. Participants complete paper safety plans as part of their regular treatment, which is a standard of care for suicidal youth. | Behavioral: ASAP (As Safe As Possible)<br>* 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.<br>Behavioral: BRITE smart phone app<br>* 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.<br>Behavioral: TAU (treatment as usual)<br>* TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive.<br>|
| Experimental: BRITE + TAU (treatment as usual)<br>Participants in this arm will receive the BRITE smart phone app for distress tolerance/emotion regulation and safety planning as they proceed from inpatient to outpatient care, in addition to usual treatment protocols that all adolescents admitted to their respective Inpatient Psychiatry program receive. Participants complete paper safety plans as part of their regular treatment, which is a standard of care for suicidal youth. | Behavioral: BRITE smart phone app<br>* 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.<br>Behavioral: TAU (treatment as usual)<br>* TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive.<br>|
| Experimental: ASAP + TAU (treatment as usual)<br>Participants in this arm will receive the ASAP (As Safe As Possible) intervention during their transition from inpatient to outpatient care, in addition to usual treatment protocols that all adolescents admitted to their respective Inpatient Psychiatry program receive. Participants complete paper safety plans as part of their regular treatment, which is a standard of care for suicidal youth. | Behavioral: ASAP (As Safe As Possible)<br>* 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.<br>Behavioral: TAU (treatment as usual)<br>* TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive.<br>|
| Active Comparator: TAU (treatment as usual) alone<br>Participants in this grouping are studied as they proceed from inpatient to outpatient care, per usual treatment protocols at each site. Participants complete paper safety plans as part of their regular treatment, which is a standard of care for suicidal youth. | Behavioral: TAU (treatment as usual)<br>* TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Columbia Suicide Severity Rating Scale (C-SSRS) | The primary outcome measure is the time to a suicide attempt or suicidal event. Ideation Intensity subscale range = 0-5 (higher values represent more severe intensity of ideation); Ideation Frequency subscale range =0-5 (higher values represent higher frequency); Suicidal Behavior subscales are categorical (yes/no) to define 1) actual attempt, 2) non-suicidal self-injurious behavior, 3) interrupted attempt, 4) aborted attempt, 5) preparatory acts or behavior, and 6) completed suicide. Actual Lethality/Medical Damage of Suicidal Behavior subscale range = 0-5 (higher values represent greater lethality/medical damage); Potential Lethality of Suicidal Behavior subscale range = 0-2 (higher values represent greater potential lethality | 1 - 24 weeks |