Establishing Efficacy of an Inpatient Intervention and Phone App to Reduce Suicidal Risk (ASAP+BRITE)

The University of Texas System (UT)

Status: Completed

Conditions: Suicide, Attempted; Suicidal Ideation

Treatments: Behavioral: TAU (treatment as usual); Behavioral: BRITE smart phone app; Behavioral: ASAP (As Safe As Possible)

Study type: Interventional

Funder types: Other

Identifiers

NCT03825588

STU 112016-057

Details and patient eligibility

About

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).

Full 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.

Enrollment: 241 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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241 participants in 4 patient groups

ASAP + BRITE + TAU (treatment as usual)

Experimental group

Description:

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.

Treatment:

Behavioral: BRITE smart phone app

Behavioral: ASAP (As Safe As Possible)

Behavioral: TAU (treatment as usual)

BRITE + TAU (treatment as usual)

Experimental group

Description:

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.

Treatment:

Behavioral: BRITE smart phone app

Behavioral: TAU (treatment as usual)

ASAP + TAU (treatment as usual)

Experimental group

Description:

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.

Treatment:

Behavioral: ASAP (As Safe As Possible)

Behavioral: TAU (treatment as usual)

TAU (treatment as usual) alone

Active Comparator group

Description:

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.

Treatment:

Behavioral: TAU (treatment as usual)