- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03825588
Establishing Efficacy of an Inpatient Intervention and Phone App to Reduce Suicidal Risk (ASAP+BRITE)
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
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Assess the relative efficacy of ASAP, BRITE and the combination on suicidal ideation, non-suicidal self-injury (NSSI), and suicide attempts, and re-hospitalizations.
- Examine mediators and moderators of treatment outcome.
- Examine the costs and cost efficacy of ASAP and BRITE and the combination.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jessica M. Jones, MA
- Phone Number: 214-456-3691
- Email: jessica.jones@utsouthwestern.edu
Study Contact Backup
- Name: Candice Biernesser, LCSW, MPH
- Phone Number: 412-586-9064
- Email: lubbertcl@upmc.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
-
-
Texas
-
Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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 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) 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.
|
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) 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.
|
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.
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.
|
TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
1 - 24 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Beth D. Kennard, PsyD, UT Southwestern Medical Center
- Principal Investigator: David A Brent, MD, University of Pittsburgh
Publications and helpful links
General 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. doi: 10.1080/15228835.2015.1106384. Epub 2015 Dec 14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 112016-057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suicidal Ideation
-
University of WashingtonUnited States Department of Defense; Military Suicide Research ConsortiumCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation ActiveUnited States
-
The Catholic University of AmericaUniversity of Washington; VA Office of Research and DevelopmentCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation Active
-
Emory UniversityGeorgia Institute of TechnologyCompletedSuicide, Suicidal IdeationUnited States
-
Henry M. Jackson Foundation for the Advancement...University of Pennsylvania; University of Michigan; Duke University; US Department... and other collaboratorsUnknownSuicide, Attempted | Suicidal Ideation ActiveUnited States
-
Technische Universität DresdenUnknownDepression | Suicidal Ideation/BehaviorGermany
-
International Islamic University, IslamabadRecruitingImpulsivity | Suicidal Ideation and BehaviorPakistan
-
VA Office of Research and DevelopmentCentral Texas Veterans Health Care SystemRecruitingHealth | Reintegration Difficulties | Suicidal Ideation and Behaviors | ConnectednessUnited States
-
Children's Hospital Medical Center, CincinnatiCompleted
-
Eisenhower Army Medical CenterAugusta University; The Geneva Foundation; Congressionally Directed Medical Research...CompletedSuicidal Ideation | Suicide | Suicidal Intention | Suicidal Impulses | Suicidal and Self-Injurious Behavior | Suicidal DepressionUnited States
-
Ohio State UniversityUniversity of Minnesota; Rutgers UniversityCompletedSuicidal Ideation | SuicidalUnited States
Clinical Trials on ASAP (As Safe As Possible)
-
University of PittsburghUniversity of Texas Southwestern Medical CenterCompletedAdolescent BehaviorUnited States
-
Foundation for Advanced Studies on International...St.Luke's Life Science Institute, Tokyo, JapanCompleted
-
Cliniques universitaires Saint-Luc- Université...CompletedHealthy | ChildrenBelgium
-
Assistance Publique - Hôpitaux de ParisRecruiting
-
Penn State UniversityCompleted
-
European University Miguel de CervantesAsociación de Familiares de Alzheimer de ValladolidCompletedAlzheimer DiseaseSpain
-
University of Massachusetts, WorcesterNational Institute of Mental Health (NIMH); Community HealthLink; Collective...Recruiting
-
Pepperdine UniversityUniversity of California, Los AngelesCompleted
-
Weill Medical College of Cornell UniversityWilliam Rhodes Center for GlioblastomaRecruiting
-
New York UniversityNot yet recruitingChild Sexual AbuseUnited States