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

• ClinicalTrials.gov Identifier: NCT03825588
• Recruitment Status: Recruiting
• First Posted: January 31, 2019
• Last Update Posted: April 9, 2021
• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: University of Pittsburgh; American Foundation for Suicide Prevention
• Information provided by (Responsible Party): Beth Kennard, University of Texas Southwestern Medical Center

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Suicidal Ideation; Suicide, Attempted	Behavioral: ASAP (As Safe As Possible); Behavioral: BRITE smart phone app; Behavioral: TAU (treatment as usual)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention 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; (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 (Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: April 1, 2019
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: September 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: ASAP + BRITE + 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.	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.; Behavioral: 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.; Behavioral: TAU (treatment as usual); TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive.
Experimental: BRITE + 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.	Behavioral: 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.; Behavioral: TAU (treatment as usual); TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive.
Experimental: ASAP + 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.	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.; Behavioral: TAU (treatment as usual); TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive.
Active Comparator: TAU (treatment as usual) alone; 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); TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive.

Outcome Measures

Primary Outcome Measures :

1. Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Jessica M. Jones, MA; 214-456-3691; jessica.jones@utsouthwestern.edu

Contact: Candice Biernesser, LCSW, MPH; 412-586-9064; lubbertcl@upmc.edu

Locations

United States, Pennsylvania

University of Pittsburgh; Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contact: Candice Biernesser, LCSW, MPH 412-586-9064 lubbertcl@upmc.edu

Principal Investigator: David A Brent, MD

United States, Texas

University of Texas Southwestern Medical Center; Recruiting

Dallas, Texas, United States, 75390

Contact: Jessica M Jones, MA 214-456-3691 jmartinjones@gmail.com

Principal Investigator: Beth D. Kennard, PsyD

Sponsors and Collaborators

University of Texas Southwestern Medical Center

University of Pittsburgh

American Foundation for Suicide Prevention

Investigators

• Principal Investigator: Beth D. Kennard, PsyD; UT Southwestern Medical Center
• Principal Investigator: David A Brent, MD; University of Pittsburgh

More Information

Publications:

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.

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. Epub 2015 Dec 14.

• Responsible Party: Beth Kennard, PROFESSOR, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT03825588
• Other Study ID Numbers: STU 112016-057
• First Posted: January 31, 2019
• Last Update Posted: April 9, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Suicide; Suicidal Ideation; Suicide, Attempted; Self-Injurious Behavior; Behavioral Symptoms