Depression, Suicidal Ideation
Conditions
Keywords
depression, suicidal ideation, anxiety, treatment, app, safety planning, provider
Brief summary
BRITEPath (BP) aims to support co-located mental health clinicians in the development of a high quality, effective, and personalized safety plan for referred patients who screen positive for depression and/or suicidal ideation. BRITEPath utilizes BRITE, a safety planning and emotion regulation app that is loaded on the patient's smart phone and has previously been shown to be well accepted and to reduce suicide attempts compared to usual care in psychiatric inpatients (HR = 0.49). To support mental health clinicians in the development of effective safety plans, study investigators will develop Guide2Brite (G2B), which provides step-by-step instructions for the mental health clinician on how to populate BRITE onto the patient's smartphone and BRITEBoard, a clinician dashboard that tracks patient symptoms, app use, and rating on helpfulness of different interventions assessed through BRITE.
Detailed description
BRITEPath has 3 components: 1) BRITE, an emotion regulation and safety planning phone app that is delivered by a co-located mental health (MH) clinician to adolescents at the time of their first therapy appointment; 2) Guide2Brite, which will guide the co-located MH clinician in working with the adolescent to population content onto BRITE; and 3) BRITEBoard, which is a clinician dashboard delivered to the MH clinician and PCP. Assignment of Interventions: This study will utilize a 1:1 randomization scheme to randomize participants to receive BRITEPath intervention or Treatment as Usual (TAU). Hypothesis: The use of BRITEPath will decrease depressive symptoms, distress, and suicidality (any self-injurious ideation, urges, or behavior) as well as improve overall functioning compared to TAU.
Interventions
BEHAVIORALBRITEPath
BRITEPath will guide co-located mental health clinicians in the use of an emotion regulation and safety planning app (BRITE) to be loaded on the phone of depressed and suicidal adolescents in order to improve depression and reduce the likelihood of a suicide attempt.
BEHAVIORALTreatment As Usual (TAU)
Participants in this group will receive usual care from their mental health care provider.
Sponsors
Kaiser Foundation Research Institute
National Institute of Mental Health (NIMH)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessors will be masked to the intervention condition at follow-up assessment time points.
Intervention model description
This study will use a parallel study design, where participants are randomized into two groups, BRITEPath or TAU, and will receive interventions in parallel.
Eligibility
Sex/Gender
ALL
Age
12 Years to 26 Years
Healthy volunteers
No
Inclusion criteria
1. Youth aged 12-26yo 2. Own a device (e.g. smartphone, iPod, tablet) with capability to download BRITE app 3. Biological or adoptive parent is willing to provide informed consent for teen to participate 4. Youth speaks and understands English 5. Positive PHQ score or provider determines youth has depressive symptoms based on clinical interaction and refers youth to the study (in cases when PHQ is not available and study staff will complete the PHQ during the screening) OR Provider can refer if they are unclear if symptoms are depressive and PHQ scoring will be used to determine youth's eligibility. OR Screening Wizard screening questionnaire (which includes the PHQ and depressive symptom questions) indicates depression OR provider/parent have concern that youth/patient has a mood or behavioral problem 6. Family agrees to see an (embedded) MH therapist at the practice 7. PHQ scores: Score of 8 or higher on PHQ-8 -or- Score of 1 or higher on #9 of PHQ-9 suicidality item
Exclusion criteria
1. Non English speaking 2. No parent willing to provide informed consent 3. No cell phone capability of downloading BRITE app 4. Is currently experiencing mania or psychosis 5. Evidence of an intellectual or developmental disorder (IDD) 6. Life threatening medical condition that requires immediate treatment (including emergent suicidality, homicidally, abuse/neglect, or other mental or physical condition) 7. Other cognitive or medical condition preventing youth from understanding study and/or participating. 8. Currently receiving MH treatment/currently satisfied with treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Severity | At 4 week follow up after Baseline | Total scores from the Patient Health Questionnaire (PHQ-9) will be used to assess depression severity, as a primary outcome. The PHQ-9 is a 9 items assessment with scoring ranging from 0-27. The higher the score, the more severe the depression symptoms are. A score of 0-4= no depression; 5-9= mild depression; 10-14= moderate depression; 15-19= moderately severe depression; 20-27= severe depression symptoms. |
| Suicidal Ideation and Behavior | At 4 week follow up after Baseline | Suicide attempt & ideation is measured through Columbia Suicide Severity Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present or answer is No, assign a score of 1 if ideation/behavior present or Yes. A Yes to question 9 (score=1) on PHQ-9 indicates suicidal ideation. Suicidal ideation or behavior= yes answer to any of suicidal behavior questions (Categories 7-10) on the CSSRS. 7- Aborted Attempt 8- Interrupted Attempt 9- Actual Attempt (non-fatal) 10- Completed Suicide. Any score greater than 0 is important/may indicate need for intervention and may indicate worse outcomes. |
| Quality of Life and Social/Emotional Functioning | At 4 week follow up after Baseline | Pediatric Quality of Life Inventory Version 4 assesses quality of life and functioning. Items on the Pediatric Quality of Life Generic Core Scales are reverse scored & transformed to 0-100 scale. Higher scores indicate better health related quality of life. 0 (Never) = 100; 1 (Almost Never) = 75; 2 (Sometimes) = 50; 3 (Often) = 25; 4 (Almost Always) = 0. The total score is Sum of all items over number of items answered. |
| Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | 4 week follow up | The Child and Adolescent Service Assessment (CASA) collects service utilization of all participants to determine the amount of services accessed. The CASA response data displayed are those who responded positively that they received the service. Those who said yes to receiving the service is scored as a 1. Multiple participants can say yes to more than 1 service. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Application Utilization-BRITE App Use by Participants | Up to 12 week follow up | Use of the technical components of interventions and web portals for BRITEPath with be monitored throughout Phase 2. Utilization will be measured by the number of participants who have engaged with the application over time, including rating distress levels in the app and utilizing the following app features: learn to savor, reaching out to contacts, soothe breathe, sooth guided meditation, crisis survival strategies, distract with happy thoughts, distract exercise, savor, and soothe activities to help you sleep. |
| Satisfaction With Technical Components | At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools) | Satisfaction with the technical components of interventions will be assessed through the certain questions from the Post System Satisfaction and Usability Questionnaire (PSSUQ). The PSSUQ is 19 items with response options ranging from 1 to 7 where 1= strongly disagree and 7= strongly agree. The PSSUQ has sub-scores derived from subsets of the questions which reflect system usefulness, information quality, and interface quality. Questions from sub-domains were chosen to tailor the questioning to this particular intervention. |
| Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Up to 12 week follow up | Use of the technical components of interventions and web portals for BRITEPath with be monitored throughout Phase 2. Use of the technical components of Guide2BRITE and the BRITEPortal for physicians will be monitored throughout Phase 1b. Utilization will be measured by the number of providers who have completed the Guide2BRITE onboarding process which includes steps 1, 1.2, 1.3, 2, 2.1, 2.2, 2.3, 2.4, 2.5, 3, 3.2, 4, 4.1, and 5. Each step includes text field components of a standard safety plan that needs to be completed. Providers who clicked next at each step after filling in the text boxes were counted. |
| Cost Estimate for Implementation of BRITEPath Intervention | At 12 week follow up after Baseline | An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilities) will be estimated. Outcome measure data below highlights the estimated cost of the intervention BRITEPath Intervention per participant, measures were based on estimates from staff and not on empirical data at the individual level. |
| Usability and Satisfaction | At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools) | Satisfaction to BRITEPath will be assessed through questions developed by investigators to understand experience with the program. Questions investigators have adapted from literature reviews on satisfaction include: If a friend were in need of mental health care for depression or suicidal thoughts or behaviors, would you recommend BRITEPath to help him/her manage symptoms? The response options include: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BRITEPath Participants will receive the components in BRITEPath from a mental health (MH) clinical trained by the study staff/PI's on how to implement BRITE safety planning with fidelity.
First, the MH clinician will review possible barriers to implementation of the safety plan and problem-solve appropriately with patient and parent(s); (2) BRITE is the emotion regulation/safety planning app loaded on the patient's smartphone that populated with support from Guide2BRITE; and (3) BRITEBoard, a clinician dashboard that shows app use, change in distress and symptoms ratings, and can be used for shared decision making with parents, patients, and PCPs. Clinicians will review adolescent's skill development and app content with parents. Prior to discharge or following acute increases in suicide risk.
BRITEPath: BRITEPath will guide co-located mental health clinicians in the use of an emotion regulation and safety planning app (BRITE) to be loaded on the phone of depressed and suicidal adolescents in order to improve depression and reduce the likelihood of a suicide attempt. | 68 |
| Treatment As Usual (TAU) Participants in the TAU group will receive treatment from their mental health clinician which may include safety planning.
Treatment As Usual (TAU): Participants in this group will receive usual care from their mental health care provider. | 33 |
| Total | 101 |
Baseline characteristics
| Characteristic | Treatment As Usual (TAU) | Total | BRITEPath |
|---|---|---|---|
| Age, Categorical <=18 years | 12 Participants | 42 Participants | 30 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 59 Participants | 38 Participants |
| Depression Severity | 11.4 score on a scale STANDARD_DEVIATION 5.7 | 10.9 score on a scale STANDARD_DEVIATION 5.9 | 10.6 score on a scale STANDARD_DEVIATION 5.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 7 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 93 Participants | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Quality of life and Social/Emotional Functioning PEDS QOL Emotional Score | 50 score on a scale STANDARD_DEVIATION 18.4 | 56.1 score on a scale STANDARD_DEVIATION 24.7 | 59 score on a scale STANDARD_DEVIATION 27.1 |
| Quality of life and Social/Emotional Functioning PEDS QOL Physical Score | 70.5 score on a scale STANDARD_DEVIATION 18 | 78.1 score on a scale STANDARD_DEVIATION 19.8 | 81.7 score on a scale STANDARD_DEVIATION 20 |
| Quality of life and Social/Emotional Functioning PEDS QOL Psychosocial Health Summary Score | 56.9 score on a scale STANDARD_DEVIATION 13.8 | 63.5 score on a scale STANDARD_DEVIATION 20.7 | 66.6 score on a scale STANDARD_DEVIATION 22.9 |
| Quality of life and Social/Emotional Functioning PEDS QOL Social Score | 69.8 score on a scale STANDARD_DEVIATION 27.9 | 74.9 score on a scale STANDARD_DEVIATION 25 | 77.4 score on a scale STANDARD_DEVIATION 23.7 |
| Quality of life and Social/Emotional Functioning PEDS QOL Total Score | 61.6 score on a scale STANDARD_DEVIATION 14.6 | 68.5 score on a scale STANDARD_DEVIATION 19.1 | 71.8 score on a scale STANDARD_DEVIATION 20.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 10 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) White | 26 Participants | 71 Participants | 45 Participants |
| Region of Enrollment United States | 33 participants | 101 participants | 68 participants |
| Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) Use of Emergency Services | 3 Participants | 14 Participants | 11 Participants |
| Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) Use of Inpatient Services | 7 Participants | 25 Participants | 18 Participants |
| Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) Use of Legal Services | 1 Participants | 1 Participants | 0 Participants |
| Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) Use of Medications | 26 Participants | 83 Participants | 57 Participants |
| Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) Use of Outpatient Services | 29 Participants | 90 Participants | 61 Participants |
| Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) Use of School Services | 20 Participants | 56 Participants | 36 Participants |
| Sex/Gender, Customized Female | 24 Participants | 67 Participants | 43 Participants |
| Sex/Gender, Customized Female to Male Transgender | 0 Participants | 2 Participants | 2 Participants |
| Sex/Gender, Customized Male | 4 Participants | 19 Participants | 15 Participants |
| Sex/Gender, Customized Non-binary/ Queer | 4 Participants | 12 Participants | 8 Participants |
| Sex/Gender, Customized Other Gender | 1 Participants | 1 Participants | 0 Participants |
| Suicidal Ideation and Behavior C-SSRS Category 10: Completed Suicide | 0 score on a scale STANDARD_DEVIATION 0 | 0.0 score on a scale STANDARD_DEVIATION 0 | 0 score on a scale STANDARD_DEVIATION 0 |
| Suicidal Ideation and Behavior C-SSRS Category 7: Aborted Attempts | 0 score on a scale STANDARD_DEVIATION 0 | 0.0 score on a scale STANDARD_DEVIATION 0.2 | 0 score on a scale STANDARD_DEVIATION 0.2 |
| Suicidal Ideation and Behavior C-SSRS Category 8: Interrupted Attempts | 0 score on a scale STANDARD_DEVIATION 0.2 | 0.0 score on a scale STANDARD_DEVIATION 0.1 | 0 score on a scale STANDARD_DEVIATION 0.1 |
| Suicidal Ideation and Behavior C-SSRS Category 9: Actual Attempts (non-lethal) | 0 score on a scale STANDARD_DEVIATION 0 | 0.1 score on a scale STANDARD_DEVIATION 0.3 | 0.1 score on a scale STANDARD_DEVIATION 0.3 |
| Suicidal Ideation and Behavior PHQ-9-question #9 | 0.4 score on a scale STANDARD_DEVIATION 0.8 | 0.5 score on a scale STANDARD_DEVIATION 0.8 | 0.5 score on a scale STANDARD_DEVIATION 0.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 33 |
| other Total, other adverse events | 1 / 68 | 0 / 33 |
| serious Total, serious adverse events | 0 / 68 | 0 / 33 |
Outcome results
Primary
Depression Severity
Total scores from the Patient Health Questionnaire (PHQ-9) will be used to assess depression severity, as a primary outcome. The PHQ-9 is a 9 items assessment with scoring ranging from 0-27. The higher the score, the more severe the depression symptoms are. A score of 0-4= no depression; 5-9= mild depression; 10-14= moderate depression; 15-19= moderately severe depression; 20-27= severe depression symptoms.
Time frame: At 12 week follow up after Baseline
Population: 9 intervention participants and 2 TAU participants did not complete the PHQ-9 and remain in the intention to treat analysis sample
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BRITEPath | Depression Severity | 8.3 score on a scale | Standard Deviation 5.4 |
| Treatment As Usual (TAU) | Depression Severity | 10 score on a scale | Standard Deviation 5.9 |
Primary
Depression Severity
Total scores from the Patient Health Questionnaire (PHQ-9) will be used to assess depression severity, as a primary outcome. The PHQ-9 is a 9 items assessment with scoring ranging from 0-27. The higher the score, the more severe the depression symptoms are. A score of 0-4= no depression; 5-9= mild depression; 10-14= moderate depression; 15-19= moderately severe depression; 20-27= severe depression symptoms.
Time frame: At 4 week follow up after Baseline
Population: 6 intervention participants and 1 TAU participant did not complete the PHQ-9 and remain in the intention to treat analysis sample
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BRITEPath | Depression Severity | 8.6 score on a scale | Standard Deviation 5.6 |
| Treatment As Usual (TAU) | Depression Severity | 10.8 score on a scale | Standard Deviation 5.4 |
Primary
Quality of Life and Social/Emotional Functioning
Pediatric Quality of Life Inventory Version 4 assesses quality of life and functioning. Items on the Pediatric Quality of Life Generic Core Scales are reverse scored & transformed to 0-100 scale. Higher scores indicate better health related quality of life. 0 (Never) = 100; 1 (Almost Never) = 75; 2 (Sometimes) = 50; 3 (Often) = 25; 4 (Almost Always) = 0. The total score is Sum of all items over number of items answered.
Time frame: At 4 week follow up after Baseline
Population: Only adolescents under age 18 received the PEDS-QOL measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BRITEPath | Quality of Life and Social/Emotional Functioning | PEDS QOL Emotional Score | 68.7 score on a scale | Standard Deviation 25.9 |
| BRITEPath | Quality of Life and Social/Emotional Functioning | PEDS QOL Psychosocial Health Summary Score | 73.5 score on a scale | Standard Deviation 21.6 |
| BRITEPath | Quality of Life and Social/Emotional Functioning | PEDS QOL Social Score | 81.6 score on a scale | Standard Deviation 24.1 |
| BRITEPath | Quality of Life and Social/Emotional Functioning | PEDS QOL Total Score | 79 score on a scale | Standard Deviation 16.4 |
| BRITEPath | Quality of Life and Social/Emotional Functioning | PEDS QOL Physical Score | 89.3 score on a scale | Standard Deviation 11.5 |
| Treatment As Usual (TAU) | Quality of Life and Social/Emotional Functioning | PEDS QOL Total Score | 67 score on a scale | Standard Deviation 20.4 |
| Treatment As Usual (TAU) | Quality of Life and Social/Emotional Functioning | PEDS QOL Physical Score | 71.5 score on a scale | Standard Deviation 22.5 |
| Treatment As Usual (TAU) | Quality of Life and Social/Emotional Functioning | PEDS QOL Emotional Score | 60.6 score on a scale | Standard Deviation 20.8 |
| Treatment As Usual (TAU) | Quality of Life and Social/Emotional Functioning | PEDS QOL Social Score | 76.1 score on a scale | Standard Deviation 25.8 |
| Treatment As Usual (TAU) | Quality of Life and Social/Emotional Functioning | PEDS QOL Psychosocial Health Summary Score | 64.4 score on a scale | Standard Deviation 19.9 |
Primary
Quality of Life and Social/Emotional Functioning
Pediatric Quality of Life Inventory Version 4 assesses quality of life and functioning. Items on the Pediatric Quality of Life Generic Core Scales are reverse scored & transformed to 0-100 scale. Higher scores indicate better health related quality of life. 0 (Never) = 100; 1 (Almost Never) = 75; 2 (Sometimes) = 50; 3 (Often) = 25; 4 (Almost Always) = 0. The total score is Sum of all items over number of items answered.
Time frame: At 12 week follow up after Baseline
Population: Only adolescents under age 18 received the PEDS-QOL measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BRITEPath | Quality of Life and Social/Emotional Functioning | PEDS QOL Emotional Score | 63.7 score on a scale | Standard Deviation 25.4 |
| BRITEPath | Quality of Life and Social/Emotional Functioning | PEDS QOL Psychosocial Health Summary Score | 72.8 score on a scale | Standard Deviation 23.2 |
| BRITEPath | Quality of Life and Social/Emotional Functioning | PEDS QOL Social Score | 82.6 score on a scale | Standard Deviation 27.6 |
| BRITEPath | Quality of Life and Social/Emotional Functioning | PEDS QOL Total Score | 77.8 score on a scale | Standard Deviation 19.3 |
| BRITEPath | Quality of Life and Social/Emotional Functioning | PEDS QOL Physical Score | 87.2 score on a scale | Standard Deviation 15.2 |
| Treatment As Usual (TAU) | Quality of Life and Social/Emotional Functioning | PEDS QOL Total Score | 65.9 score on a scale | Standard Deviation 16.4 |
| Treatment As Usual (TAU) | Quality of Life and Social/Emotional Functioning | PEDS QOL Physical Score | 74 score on a scale | Standard Deviation 20.4 |
| Treatment As Usual (TAU) | Quality of Life and Social/Emotional Functioning | PEDS QOL Emotional Score | 50.6 score on a scale | Standard Deviation 20.7 |
| Treatment As Usual (TAU) | Quality of Life and Social/Emotional Functioning | PEDS QOL Social Score | 72.2 score on a scale | Standard Deviation 29.4 |
| Treatment As Usual (TAU) | Quality of Life and Social/Emotional Functioning | PEDS QOL Psychosocial Health Summary Score | 61.7 score on a scale | Standard Deviation 16.4 |
Primary
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
The Child and Adolescent Service Assessment (CASA) collects service utilization of all participants to determine the amount of services accessed. The CASA response data displayed are those who responded positively that they received the service. Those who said yes to receiving the service is scored as a 1. Multiple participants can say yes to more than 1 service.
Time frame: 12 week follow up
Population: 9 intervention participants did not complete week 12 assessment and 2 TAU participants did not complete week 12 assessment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BRITEPath | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use outpatient services | 45 Participants |
| BRITEPath | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use school services | 4 Participants |
| BRITEPath | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use emergency services | 0 Participants |
| BRITEPath | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use legal services | 0 Participants |
| BRITEPath | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use inpatient services | 1 Participants |
| BRITEPath | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use medications | 32 Participants |
| Treatment As Usual (TAU) | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use inpatient services | 0 Participants |
| Treatment As Usual (TAU) | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use outpatient services | 23 Participants |
| Treatment As Usual (TAU) | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use legal services | 0 Participants |
| Treatment As Usual (TAU) | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use school services | 1 Participants |
| Treatment As Usual (TAU) | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use medications | 14 Participants |
| Treatment As Usual (TAU) | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use emergency services | 0 Participants |
Primary
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
The Child and Adolescent Service Assessment (CASA) collects service utilization of all participants to determine the amount of services accessed. The CASA response data displayed are those who responded positively that they received the service. Those who said yes to receiving the service is scored as a 1. Multiple participants can say yes to more than 1 service.
Time frame: 4 week follow up
Population: 6 intervention participants did not complete week 4 assessment and 1 TAU participant did not complete week 4 assessment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BRITEPath | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use school services | 5 Participants |
| BRITEPath | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use legal services | 0 Participants |
| BRITEPath | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use outpatient services | 45 Participants |
| BRITEPath | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use inpatient services | 1 Participants |
| BRITEPath | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use emergency services | 0 Participants |
| BRITEPath | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use medications | 33 Participants |
| Treatment As Usual (TAU) | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use medications | 18 Participants |
| Treatment As Usual (TAU) | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use outpatient services | 25 Participants |
| Treatment As Usual (TAU) | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use school services | 2 Participants |
| Treatment As Usual (TAU) | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use emergency services | 0 Participants |
| Treatment As Usual (TAU) | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use legal services | 0 Participants |
| Treatment As Usual (TAU) | Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) | Use inpatient services | 0 Participants |
Primary
Suicidal Ideation and Behavior
Suicide attempt & ideation is measured through Columbia Suicide Severity Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present or answer is No, assign a score of 1 if ideation/behavior present or Yes. A Yes to question 9 (score=1) on PHQ-9 indicates suicidal ideation. Suicidal ideation or behavior= yes answer to any of suicidal behavior questions (Categories 7-10) on the CSSRS. 7- Aborted Attempt 8- Interrupted Attempt 9- Actual Attempt (non-fatal) 10- Completed Suicide. Any score greater than 0 is important/may indicate need for intervention and may indicate worse outcomes.
Time frame: At 12 week follow up after Baseline
Population: 9 intervention participants and 2 TAU participants did not complete the C-SSRS and remain in the intention to treat analysis sample
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BRITEPath | Suicidal Ideation and Behavior | C-SSRS Category 7: Aborted Attempt | 0 score on a scale | Standard Deviation 0.2 |
| BRITEPath | Suicidal Ideation and Behavior | C-SSRS Category 9: Actual Attempt (non-fatal) | 0 score on a scale | Standard Deviation 0 |
| BRITEPath | Suicidal Ideation and Behavior | C-SSRS Category 8: Interrupted Attempt | 0 score on a scale | Standard Deviation 0 |
| BRITEPath | Suicidal Ideation and Behavior | C-SSRS Category 10: Completed Suicide | 0 score on a scale | Standard Deviation 0 |
| BRITEPath | Suicidal Ideation and Behavior | PHQ-9 Question 9 (ideation) | 0.2 score on a scale | Standard Deviation 0.5 |
| Treatment As Usual (TAU) | Suicidal Ideation and Behavior | C-SSRS Category 10: Completed Suicide | 0 score on a scale | Standard Deviation 0 |
| Treatment As Usual (TAU) | Suicidal Ideation and Behavior | PHQ-9 Question 9 (ideation) | 0.4 score on a scale | Standard Deviation 0.7 |
| Treatment As Usual (TAU) | Suicidal Ideation and Behavior | C-SSRS Category 7: Aborted Attempt | 0 score on a scale | Standard Deviation 0 |
| Treatment As Usual (TAU) | Suicidal Ideation and Behavior | C-SSRS Category 8: Interrupted Attempt | 0 score on a scale | Standard Deviation 0 |
| Treatment As Usual (TAU) | Suicidal Ideation and Behavior | C-SSRS Category 9: Actual Attempt (non-fatal) | 0 score on a scale | Standard Deviation 0 |
Primary
Suicidal Ideation and Behavior
Suicide attempt & ideation is measured through Columbia Suicide Severity Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present or answer is No, assign a score of 1 if ideation/behavior present or Yes. A Yes to question 9 (score=1) on PHQ-9 indicates suicidal ideation. Suicidal ideation or behavior= yes answer to any of suicidal behavior questions (Categories 7-10) on the CSSRS. 7- Aborted Attempt 8- Interrupted Attempt 9- Actual Attempt (non-fatal) 10- Completed Suicide. Any score greater than 0 is important/may indicate need for intervention and may indicate worse outcomes.
Time frame: At 4 week follow up after Baseline
Population: 6 intervention participants and 1 TAU participant did not complete the C-SSRS and remain in the intention to treat analysis sample
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BRITEPath | Suicidal Ideation and Behavior | C-SSRS Category 7: Aborted Attempt | 0 score on a scale | Standard Deviation 0 |
| BRITEPath | Suicidal Ideation and Behavior | C-SSRS Category 9: Actual Attempt (non-fatal) | 0 score on a scale | Standard Deviation 0 |
| BRITEPath | Suicidal Ideation and Behavior | C-SSRS Category 8: Interrupted Attempt | 0 score on a scale | Standard Deviation 0 |
| BRITEPath | Suicidal Ideation and Behavior | C-SSRS Category 10: Completed Suicide | 0 score on a scale | Standard Deviation 0 |
| BRITEPath | Suicidal Ideation and Behavior | PHQ-9 question #9 | 0.3 score on a scale | Standard Deviation 0.7 |
| Treatment As Usual (TAU) | Suicidal Ideation and Behavior | C-SSRS Category 10: Completed Suicide | 0 score on a scale | Standard Deviation 0 |
| Treatment As Usual (TAU) | Suicidal Ideation and Behavior | PHQ-9 question #9 | 0.5 score on a scale | Standard Deviation 0.9 |
| Treatment As Usual (TAU) | Suicidal Ideation and Behavior | C-SSRS Category 7: Aborted Attempt | 0 score on a scale | Standard Deviation 0 |
| Treatment As Usual (TAU) | Suicidal Ideation and Behavior | C-SSRS Category 8: Interrupted Attempt | 0 score on a scale | Standard Deviation 0 |
| Treatment As Usual (TAU) | Suicidal Ideation and Behavior | C-SSRS Category 9: Actual Attempt (non-fatal) | 0 score on a scale | Standard Deviation 0 |
Secondary
Application Utilization-BRITE App Use by Participants
Use of the technical components of interventions and web portals for BRITEPath with be monitored throughout Phase 2. Utilization will be measured by the number of participants who have engaged with the application over time, including rating distress levels in the app and utilizing the following app features: learn to savor, reaching out to contacts, soothe breathe, sooth guided meditation, crisis survival strategies, distract with happy thoughts, distract exercise, savor, and soothe activities to help you sleep.
Time frame: Up to 12 week follow up
Population: 68/68 participants received the intervention.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| BRITEPath | Application Utilization-BRITE App Use by Participants | First distress level | Completed | 37 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | First distress level | Did not complete | 31 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Second distress level | Completed | 29 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Second distress level | Did not complete | 39 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Learn to savor | Completed | 4 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Learn to savor | Did not complete | 64 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Reaching out to contacts | Completed | 11 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Reaching out to contacts | Did not complete | 57 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Soothe Breathe | Completed | 17 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Soothe Breathe | Did not complete | 51 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Soothe Guided Meditation | Completed | 9 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Soothe Guided Meditation | Did not complete | 59 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Crisis survival strategies | Completed | 14 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Crisis survival strategies | Did not complete | 54 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Distract with happy thoughts | Completed | 17 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Distract with happy thoughts | Did not complete | 51 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Distract exercise | Completed | 13 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Distract exercise | Did not complete | 55 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Savor | Completed | 15 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Savor | Did not complete | 53 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Soothe activities to help you sleep | Completed | 10 Participants |
| BRITEPath | Application Utilization-BRITE App Use by Participants | Soothe activities to help you sleep | Did not complete | 58 Participants |
Secondary
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Use of the technical components of interventions and web portals for BRITEPath with be monitored throughout Phase 2. Use of the technical components of Guide2BRITE and the BRITEPortal for physicians will be monitored throughout Phase 1b. Utilization will be measured by the number of providers who have completed the Guide2BRITE onboarding process which includes steps 1, 1.2, 1.3, 2, 2.1, 2.2, 2.3, 2.4, 2.5, 3, 3.2, 4, 4.1, and 5. Each step includes text field components of a standard safety plan that needs to be completed. Providers who clicked next at each step after filling in the text boxes were counted.
Time frame: Up to 12 week follow up
Population: 68/68 participants were onboarded by clinician.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 1 | Completed | 41 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 1 | Did not complete | 27 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 1.2 | Completed | 41 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 1.2 | Did not complete | 27 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 1.3 | Completed | 41 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 1.3 | Did not complete | 27 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 2 | Completed | 0 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 2 | Did not complete | 68 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 2.1 | Completed | 41 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 2.1 | Did not complete | 27 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 2.2 | Completed | 41 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 2.2 | Did not complete | 27 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 2.3 | Completed | 41 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 2.3 | Did not complete | 27 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 2.4 | Completed | 41 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 2.4 | Did not complete | 27 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 2.5 | Completed | 41 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 2.5 | Did not complete | 27 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 3 | Completed | 41 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 3 | Did not complete | 27 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 3.2 | Completed | 41 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 3.2 | Did not complete | 27 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 4 | Completed | 0 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 4 | Did not complete | 68 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 4.1 | Completed | 40 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 4.1 | Did not complete | 28 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 5 | Completed | 2 Participants |
| BRITEPath | Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process | Step 5 | Did not complete | 66 Participants |
Secondary
Cost Estimate for Implementation of BRITEPath Intervention
An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilities) will be estimated. Outcome measure data below highlights the estimated cost of the intervention BRITEPath Intervention per participant, measures were based on estimates from staff and not on empirical data at the individual level.
Time frame: At 12 week follow up after Baseline
Population: 68/68 participants received BRITEPath onboarding
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BRITEPath | Cost Estimate for Implementation of BRITEPath Intervention | 457.43 dollars per participant |
Secondary
Satisfaction With Technical Components
Satisfaction with the technical components of interventions will be assessed through the certain questions from the Post System Satisfaction and Usability Questionnaire (PSSUQ). The PSSUQ is 19 items with response options ranging from 1 to 7 where 1= strongly disagree and 7= strongly agree. The PSSUQ has sub-scores derived from subsets of the questions which reflect system usefulness, information quality, and interface quality. Questions from sub-domains were chosen to tailor the questioning to this particular intervention.
Time frame: At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools)
Population: Some participants did not respond to all questions in PSSUQ measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BRITEPath | Satisfaction With Technical Components | Overall, I am satisfied with how easy it is to use BRITE App. | 4.7 score on a scale | Standard Deviation 2 |
| BRITEPath | Satisfaction With Technical Components | The information provided with BRITE App such as online help was clear | 5.2 score on a scale | Standard Deviation 2.1 |
| BRITEPath | Satisfaction With Technical Components | The information provided with BRITE App such as notifications to rate my mood was clear | 5 score on a scale | Standard Deviation 2.1 |
| BRITEPath | Satisfaction With Technical Components | The information provided during the onboarding with my therapist was clear | 5.3 score on a scale | Standard Deviation 2 |
| BRITEPath | Satisfaction With Technical Components | I liked interacting with the BRITE app program | 4.6 score on a scale | Standard Deviation 1.9 |
| BRITEPath | Satisfaction With Technical Components | I needed to learn a lot of things before I could get going with BRITE App | 1.8 score on a scale | Standard Deviation 1.1 |
Secondary
Usability and Satisfaction
Satisfaction to BRITEPath will be assessed through questions developed by investigators to understand experience with the program. Questions investigators have adapted from literature reviews on satisfaction include: If a friend were in need of mental health care for depression or suicidal thoughts or behaviors, would you recommend BRITEPath to help him/her manage symptoms? The response options include: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely
Time frame: At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools)
Population: 51 participants responded to 2 of the exit interview items and 50 participants responded to the 3rd exit interview item
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BRITEPath | Usability and Satisfaction | No, definitely not | 8 Participants |
| BRITEPath | Usability and Satisfaction | No don't think so | 8 Participants |
| BRITEPath | Usability and Satisfaction | Yes, I think so | 19 Participants |
| BRITEPath | Usability and Satisfaction | Yes, definitely | 16 Participants |
Secondary
Usability and Satisfaction
Satisfaction to BRITEPath will be assessed through questions developed by investigators to understand experience with the program. Questions investigators have adapted from literature reviews on satisfaction include: How satisfied are you with the amount of help you received? The response options include: Very Dissatisfied, Dissatisfied, Satisfied, Very Satisfied
Time frame: At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools)
Population: 51 participants responded to 2 of the exit interview items and 50 participants responded to the 3rd exit interview item
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BRITEPath | Usability and Satisfaction | Very Dissatisfied | 5 Participants |
| BRITEPath | Usability and Satisfaction | Dissatisfied | 6 Participants |
| BRITEPath | Usability and Satisfaction | Satisfied | 30 Participants |
| BRITEPath | Usability and Satisfaction | Very Satisfied | 10 Participants |
Secondary
Usability and Satisfaction
Satisfaction to BRITEPath will be assessed through questions developed by investigators to understand experience with the program. Questions investigators have adapted from literature reviews on satisfaction include: Have the services you received helped you to deal more effectively with your problem? The response options include: Seemed to make things worse, Really didn't help, Yes, somewhat, or Yes, a great deal.
Time frame: At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools)
Population: 51 participants responded to 2 of the exit interview items and 50 participants responded to the 3rd exit interview item
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BRITEPath | Usability and Satisfaction | Seemed to make things worse | 2 Participants |
| BRITEPath | Usability and Satisfaction | Really didn't help | 11 Participants |
| BRITEPath | Usability and Satisfaction | Yes, somewhat | 26 Participants |
| BRITEPath | Usability and Satisfaction | Yes, a great deal | 11 Participants |