Suicidal IdeationASAP+BRITENCT03825588
Establishing Efficacy of an Inpatient Intervention and Phone App to Reduce Suicidal Risk
A study testing ASAP (As Safe As Possible), BRITE smart phone app and TAU (treatment as usual) in people with Suicidal Ideation and Suicide, Attempted, run by University of Texas Southwestern Medical Center at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Suicidal Ideation, Suicide, Attempted
- What is being tested?
- ASAP (As Safe As Possible), BRITE smart phone app and TAU (treatment as usual)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2019to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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
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).
Read the 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.
- Conditions
- Suicidal Ideation, Suicide, Attempted
- Being tested
- ASAP (As Safe As Possible), BRITE smart phone app, TAU (treatment as usual)
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASAP (As Safe As Possible)Behavioural
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 appBehavioural
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)Behavioural
TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: TAU (treatment as usual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 1 to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Apr 2019
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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 (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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, American Foundation for Suicide Prevention
- Responsible party
- Principal investigator, Beth Kennard, University of Texas Southwestern Medical Center
- Investigators
- Beth D. Kennard, PsyD, Principal investigator, University of Texas Southwestern Medical CenterDavid A Brent, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825588
- Sponsor's protocol ID
- STU 112016-057
- Acronym
- ASAP+BRITE
- Status last verified
- Jan 2025
- First submitted
- 10 Dec 2018
- Last updated
- 31 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30021457Kennard 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.
PubMed 26977137Goldstein 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.
PubMed 39032815
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03825588
- Acronym / sponsor ID
- ASAP+BRITE / STU 112016-057
- Conditions
- Suicidal Ideation, Suicide, Attempted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- University of Pittsburgh, American Foundation for Suicide Prevention
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Posted 31 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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 (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.
| Arm | Type | Receives |
|---|---|---|
| ASAP + BRITE + TAU (treatment as usual) | Experimental | Behavioral: ASAP (As Safe As Possible), Behavioral: BRITE smart phone app, Behavioral: 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. |
| BRITE + TAU (treatment as usual) | Experimental | Behavioral: BRITE smart phone app, Behavioral: 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. |
| ASAP + TAU (treatment as usual) | Experimental | Behavioral: ASAP (As Safe As Possible), Behavioral: 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. |
| TAU (treatment as usual) alone | Active comparator | Behavioral: TAU (treatment as usual)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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | ASAP + BRITE + TAU (treatment as usual), ASAP + TAU (treatment as usual) |
| BRITE smart phone appBRITE 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. | Behavioural | ASAP + BRITE + TAU (treatment as usual), BRITE + TAU (treatment as usual) |
| TAU (treatment as usual)TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive. | Behavioural | ASAP + BRITE + TAU (treatment as usual), ASAP + TAU (treatment as usual), BRITE + TAU (treatment as usual), TAU (treatment as usual) alone |
Primary outcome
Participants With Actual Suicide Attempts as Defined by Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 1 - 24 weeks
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)
Suicidal Events
Time frame: 1 to 24 weeks
Defined as actual, aborted, or interrupted attempt based on the the Columbia-Suicide Severity Rating Scale (C-SSRS), and or rehospitalization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30021457Kennard 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.
- Background: PubMed 26977137Kennard 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.
- Derived from this study: PubMed 39032815Goldstein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth D. Kennard, PsyD principal investigator
University of Texas Southwestern Medical Center
David A Brent, MD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASAP (As Safe As Possible), BRITE smart phone app and TAU (treatment as usual) in people with Suicidal Ideation and Suicide, Attempted, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With Actual Suicide Attempts as Defined by Columbia Suicide Severity Rating Scale (C-SSRS) (time frame: 1 - 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03825588, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.