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

NCT03825588 | Completed Results DMC

• 1 other identifier: STU 112016-057
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 2

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).

Conditions

Suicidal Ideation; Suicide, Attempted

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  1 to 24 weeks

Study Arms (4)

ASAP + BRITE + TAU (treatment as usual)

EXPERIMENTAL

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); Behavioral: BRITE smart phone app; Behavioral: TAU (treatment as usual)

BRITE + TAU (treatment as usual)

EXPERIMENTAL

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; Behavioral: TAU (treatment as usual)

ASAP + TAU (treatment as usual)

EXPERIMENTAL

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); Behavioral: TAU (treatment as usual)

TAU (treatment as usual) alone

ACTIVE COMPARATOR

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)

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.

ASAP + BRITE + TAU (treatment as usual); ASAP + TAU (treatment as usual)

BRITE smart phone app BEHAVIORAL

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.

ASAP + BRITE + TAU (treatment as usual); BRITE + TAU (treatment as usual)

TAU (treatment as usual) BEHAVIORAL

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

ASAP + BRITE + TAU (treatment as usual); ASAP + TAU (treatment as usual); BRITE + TAU (treatment as usual); TAU (treatment as usual) alone

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• University of Pittsburgh: collaborator
• American Foundation for Suicide Prevention: collaborator

Study Sites (2)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (3)

• 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.

  PMID: 30021457 BACKGROUND

• 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.

  PMID: 26977137 BACKGROUND

• Goldstein TR, Kennard BD, Porta G, Miller AO, Aguilar K, Bigley K, Vaughn-Coaxum RA, McMakin DL, Douaihy A, Iyengar S, Biernesser CL, Zelazny J, Brent DA. Bridging Gaps in Care Following Hospitalization for Suicidal Adolescents: As Safe As Possible (ASAP) and BRITE App. J Am Acad Child Adolesc Psychiatry. 2025 May;64(5):612-624. doi: 10.1016/j.jaac.2024.06.008. Epub 2024 Jul 18.

  PMID: 39032815 DERIVED

MeSH Terms

Conditions

Suicidal Ideation; Suicide, Attempted

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Limitations and Caveats

Methods were modified with treatment delivered virtually post hospital discharge due to COVID. Limited diversity of the sample may reflect substantial disparities in mental health service provision for suicidal youth.

Results Point of Contact

• Title: Dr. Beth Dohoney Kennard; Dr. David Brent
• Organization: University of Texas Southwestern Medical Center, University of Pittsburgh

beth.kennard@utsouthwestern.edu

214.456.4244

Study Officials

• Beth D. Kennard, PsyD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• David A Brent, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: During the RCT, the independent evaluator (IE) will be blinded to the assigned condition and will take the following steps to preserve the blind: participants and families will be asked not to share with the IE which condition they are assigned to; at staff meetings when cases are reviewed, IEs will not be present; IEs will be asked to guess what the treatment assignment is at the end of each interview, and they will notify the project coordinator if they become unblinded. Participants will complete complementary self-report forms that will not be influenced by interviewer bias.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: January 31, 2019
• Study Start: April 1, 2019
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: January 31, 2025
• Results First Posted: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)