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

Not Applicable

Completed

• Conditions: Suicidal Ideation; Suicide, Attempted
• Interventions: Behavioral: TAU (treatment as usual); Behavioral: ASAP (As Safe As Possible); Behavioral: BRITE smart phone app

• Registration Number: NCT03825588
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-31
• Study Start: 2019-04-01
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
TAU (treatment as usual) alone	TAU (treatment as usual)	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.
ASAP + BRITE + TAU (treatment as usual)	BRITE smart phone app	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.
BRITE + TAU (treatment as usual)	BRITE smart phone app	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.
BRITE + TAU (treatment as usual)	TAU (treatment as usual)	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.
ASAP + TAU (treatment as usual)	TAU (treatment as usual)	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.
ASAP + BRITE + TAU (treatment as usual)	TAU (treatment as usual)	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.
ASAP + BRITE + TAU (treatment as usual)	ASAP (As Safe As Possible)	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.
ASAP + TAU (treatment as usual)	ASAP (As Safe As Possible)	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.

Primary Outcome Measures

Name	Time	Method
Columbia Suicide Severity Rating Scale (C-SSRS)	1 - 24 weeks	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

Trial Locations

Locations (2)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States