Suicidal Ideation, Suicide, Attempted
Conditions
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).
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.
Interventions
BEHAVIORALASAP (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.
BEHAVIORALBRITE 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.
BEHAVIORALTAU (treatment as usual)
TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive.
Sponsors
University of Pittsburgh
American Foundation for Suicide Prevention
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
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.
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 (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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Actual Suicide Attempts as Defined by Columbia Suicide Severity Rating Scale (C-SSRS) | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| 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. | 58 |
| 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. | 61 |
| 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. | 61 |
| Total | 240 |
Baseline characteristics
| Characteristic | BRITE + TAU (Treatment as Usual) | ASAP + TAU (Treatment as Usual) | ASAP + BRITE + TAU (Treatment as Usual) | TAU (Treatment as Usual) Alone | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 58 Participants | 61 Participants | 60 Participants | 61 Participants | 240 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.74 years STANDARD_DEVIATION 1.57 | 14.52 years STANDARD_DEVIATION 1.57 | 14.67 years STANDARD_DEVIATION 1.5 | 14.57 years STANDARD_DEVIATION 1.59 | 14.62 years STANDARD_DEVIATION 1.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 11 Participants | 14 Participants | 9 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 50 Participants | 45 Participants | 51 Participants | 189 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants |
| Number of Participants with Actual Suicide Attempts and Suicide Events in Past 3 Months Actual attempts in past 3 months | 38 Participants | 37 Participants | 45 Participants | 39 Participants | 159 Participants |
| Number of Participants with Actual Suicide Attempts and Suicide Events in Past 3 Months Suicide events in past 3 months | 48 Participants | 46 Participants | 53 Participants | 47 Participants | 194 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 6 Participants | 6 Participants | 9 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 7 Participants | 3 Participants | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 4 Participants | 2 Participants | 14 Participants |
| Race (NIH/OMB) White | 42 Participants | 47 Participants | 42 Participants | 46 Participants | 177 Participants |
| Region of Enrollment United States | 58 participants | 61 participants | 60 participants | 61 participants | 240 participants |
| Sex: Female, Male Female | 47 Participants | 53 Participants | 47 Participants | 47 Participants | 194 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 13 Participants | 14 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 58 | 0 / 61 | 0 / 61 |
| other Total, other adverse events | 0 / 60 | 0 / 58 | 1 / 61 | 1 / 61 |
| serious Total, serious adverse events | 0 / 60 | 0 / 58 | 0 / 61 | 1 / 61 |
Outcome results
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)
Time frame: 1 - 24 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ASAP + BRITE + TAU (Treatment as Usual) | Participants With Actual Suicide Attempts as Defined by Columbia Suicide Severity Rating Scale (C-SSRS) | 6 Participants |
| BRITE + TAU (Treatment as Usual) | Participants With Actual Suicide Attempts as Defined by Columbia Suicide Severity Rating Scale (C-SSRS) | 11 Participants |
| ASAP + TAU (Treatment as Usual) | Participants With Actual Suicide Attempts as Defined by Columbia Suicide Severity Rating Scale (C-SSRS) | 12 Participants |
| TAU (Treatment as Usual) Alone | Participants With Actual Suicide Attempts as Defined by Columbia Suicide Severity Rating Scale (C-SSRS) | 10 Participants |
Comparison: Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on the rate of actual suicide attemptsp-value: 0.71Chi-squared
Comparison: Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the rate of actual suicide attemptsp-value: 0.43Chi-squared
Comparison: Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Interaction effect of ASAP and BRITE.p-value: 0.2195% CI: [0.1, 1.66]Regression, Logistic
Comparison: Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Main effect of ASAPp-value: 0.5795% CI: [0.51, 3.34]Regression, Logistic
Comparison: Compare the 4 arms on the rate of actual suicide attempts in a 2x2 factorial design. Main effect of BRITE.p-value: 0.7795% CI: [0.44, 2.97]Regression, Logistic
Comparison: Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on time to actual suicide attemptp-value: 0.7495% CI: [0.48, 1.69]Regression, Cox
Comparison: Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the time to actual suicide attemptp-value: 0.4595% CI: [0.42, 1.48]Regression, Cox
Comparison: Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Interaction effect of ASAP and BRITEp-value: 0.2595% CI: [0.13, 1.72]Regression, Cox
Comparison: Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of ASAP.p-value: 0.6295% CI: [0.54, 2.87]Regression, Cox
Comparison: Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of BRITE.p-value: 0.8395% CI: [0.47, 2.59]Regression, Cox
Primary
Suicidal Events
Defined as actual, aborted, or interrupted attempt based on the the Columbia-Suicide Severity Rating Scale (C-SSRS), and or rehospitalization.
Time frame: 1 to 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ASAP + BRITE + TAU (Treatment as Usual) | Suicidal Events | 12 events |
| BRITE + TAU (Treatment as Usual) | Suicidal Events | 23 events |
| ASAP + TAU (Treatment as Usual) | Suicidal Events | 18 events |
| TAU (Treatment as Usual) Alone | Suicidal Events | 17 events |
Comparison: Compare participants receiving ASAP (ASAP+TAU and ASAP+BRITE+TAU) to those who do not (BRITE+TAU and TAU) on the rate of suicidal eventsp-value: 0.19Chi-squared
Comparison: Compare participants receiving BRITE (BRITE+TAU and ASAP+BRITE+TAU) to those who do not (ASAP+TAU and TAU) on the rate of suicidal eventsp-value: 0.89Chi-squared
Comparison: Compare participants the 4 arms on the rate of suicidal events in a 2x2 factorial design. Interaction effect of ASAP and BRITE.p-value: 0.0895% CI: [0.11, 1.1]Regression, Logistic
Comparison: Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of ASAP.p-value: 0.7495% CI: [0.51, 2.55]Regression, Logistic
Comparison: Compare the 4 arms on time to actual suicide attempt in a 2x2 factorial design. Main effect of BRITE.p-value: 0.1995% CI: [0.77, 3.69]Regression, Logistic