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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
| American Foundation for Suicide Prevention | OTHER |
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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth D. Kennard, PsyD | University of Texas Southwestern Medical Center | Principal Investigator |
| David A Brent, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States | ||
| University of Texas Southwestern Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30021457 | Background | 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. | |
| 26977137 |
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A total of 241 adolescents were randomized. One randomization accidentally occurred before completion of the baseline assessment, and the participant withdrew consent prior to starting the intervention. No data were collected for this participant. Thus, this report includes 240 adolescents.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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): 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 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. TAU (treatment as usual): TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive. |
| FG001 | 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 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. TAU (treatment as usual): TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive. |
| FG002 | 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): 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): TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive. |
| FG003 | 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): TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
A total of 241 adolescents were randomized. One randomization accidentally occurred before completion of the baseline assessment, and the participant withdrew consent prior to starting the intervention. No data were collected for this participant. Thus, this report includes 240 adolescents.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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): 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 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. TAU (treatment as usual): TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Count of Participants | Participants | No | 1 - 24 weeks |
|
up to 24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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): 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 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. TAU (treatment as usual): TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide Attempt | Psychiatric disorders | Systematic Assessment | Suicide attempt and hospitalized for broken neck |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Room Visit | Social circumstances | Systematic Assessment | Sexual assault |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Beth Dohoney Kennard; Dr. David Brent | University of Texas Southwestern Medical Center, University of Pittsburgh | 214.456.4244 | beth.kennard@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2021 | Oct 23, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| D013406 | Suicide, Attempted |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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.
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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.
| 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. |
|
|
| 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. |
|
| TAU (treatment as usual) | Behavioral | TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive. |
|
| Dallas |
| Texas |
| 75390 |
| United States |
| 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. |
| 39032815 | Derived | 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. |
| BG001 | 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 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. TAU (treatment as usual): TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive. |
| BG002 | 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): 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): TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive. |
| BG003 | 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): TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Participants with Actual Suicide Attempts and Suicide Events in Past 3 Months | Actual Attempts: Measured by the CSSRS = Columbia-Suicide Severity Rating Scale Suicide Events: Suicidal events were operationalized as any suicide attempt (actual, interrupted, and/or aborted) and/or re-hospitalization over follow-up.Re-hospitalization was assessed at follow-up using the Child and Adolescent Services Assessment (CASA), 37 defined as any inpatient hospitalization in a psychiatric hospital, a psychiatric unit in a general hospital, or a medical inpatient unit for emotional, behavioral, or substance use problems. | Count of Participants | Participants |
|
| OG001 | 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 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. TAU (treatment as usual): TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive. |
| OG002 | 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): 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): TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive. |
| OG003 | 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): TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive. |
|
|
|
| Primary | Suicidal Events | Defined as actual, aborted, or interrupted attempt based on the the Columbia-Suicide Severity Rating Scale (C-SSRS), and or rehospitalization. | Posted | Number | events | No | 1 to 24 weeks |
|
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | 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 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. TAU (treatment as usual): TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive. | 0 | 58 | 0 | 58 | 0 | 58 |
| EG002 | 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): 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): TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive. | 0 | 61 | 0 | 61 | 1 | 61 |
| EG003 | 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): TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive. | 0 | 61 | 1 | 61 | 1 | 61 |
|
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| Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the rate of suicidal events | Chi-squared | 0.89 | False Discovery Rate q-value > 0.99 | 2-Sided | 95 | Superiority |
| Compare participants the 4 arms on the rate of suicidal events in a 2x2 factorial design. Interaction effect of ASAP and BRITE. | Regression, Logistic | 0.08 | False Discovery Rate q-value = 0.72 | Odds Ratio (OR) | 0.35 | 2-Sided | 95 | 0.11 | 1.10 | Superiority |
| Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of ASAP. | Regression, Logistic | 0.74 | False Discovery Rate q > 0.99 | Odds Ratio (OR) | 1.14 | 2-Sided | 95 | 0.51 | 2.55 | Superiority |
| Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of BRITE. | Regression, Logistic | 0.19 | False Discovery Rate q=0.72 | Odds Ratio (OR) | 1.69 | 2-Sided | 95 | 0.77 | 3.69 | Superiority |