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

Suicidal Ideation Clinical Trial

— ASAP+BRITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03825588
• Other study ID #: STU 112016-057
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 15, 2022

Study information

• Verified date: February 2023
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• ASAP (As Safe As Possible)
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 app
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)
TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	American Foundation for Suicide Prevention, University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kennard BD, Biernesser C, Wolfe KL, Foxwell AA, Craddock Lee SJ, Rial KV, Patel S, Cheng C, Goldstein T, McMakin D, Blastos B, Douaihy A, Zelazny J, Brent DA. Developing a Brief Suicide Prevention Intervention and Mobile Phone Application: a Qualitative Report. J Technol Hum Serv. 2015 Oct 1;33(4):345-357. doi: 10.1080/15228835.2015.1106384. Epub 2015 Dec 14. — View Citation

Kennard BD, Goldstein T, Foxwell AA, McMakin DL, Wolfe K, Biernesser C, Moorehead A, Douaihy A, Zullo L, Wentroble E, Owen V, Zelazny J, Iyengar S, Porta G, Brent D. As Safe as Possible (ASAP): A Brief App-Supported Inpatient Intervention to Prevent Postdischarge Suicidal Behavior in Hospitalized, Suicidal Adolescents. Am J Psychiatry. 2018 Sep 1;175(9):864-872. doi: 10.1176/appi.ajp.2018.17101151. Epub 2018 Jul 19. Erratum In: Am J Psychiatry. 2019 Sep 1;176(9):764. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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