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

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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.




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




Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825588


Contacts
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Contact: Jessica M. Jones, MA 214-456-3691 jessica.jones@utsouthwestern.edu
Contact: Candice Biernesser, LCSW, MPH 412-586-9064 lubbertcl@upmc.edu

Locations
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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
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Principal Investigator: Beth D. Kennard, PsyD UT Southwestern Medical Center
Principal Investigator: David A Brent, MD University of Pittsburgh
Publications:
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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    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Suicide
Suicidal Ideation
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms