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| ID | Type | Description | Link |
|---|---|---|---|
| P50MH115838-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Kaiser Foundation Research Institute | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRITEPath | Experimental | 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. |
|
| Treatment As Usual (TAU) | Active Comparator | Participants in the TAU group will receive treatment from their mental health clinician which may include safety planning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BRITEPath | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 4 week follow up after Baseline |
| 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. | At 12 week follow up after Baseline |
| 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. | At 4 week follow up after Baseline |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Stepp, PhD | University of Pittsburgh | Principal Investigator |
| David Brent, MD | University of Pittsburgh | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48126 | United States | ||
| Northwell Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42261184 | Derived | Toukhy N, Biernesser C, Zelazny J, George-Milford B, Monteverde C, Porta G, Abebe KZ, Brent D, Stepp S. Examining BRITEpath, a Digital Intervention for Reducing Adolescent Suicide Risk in Primary Care: A Randomized-Controlled Trial. Suicide Life Threat Behav. 2026 Jun;56(3):e70114. doi: 10.1111/sltb.70114. |
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All requests for study data will follow NIMH's data sharing and data use policies. The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies, including those funded by the innovation contests. These analytic datasets may also include derived variables with documentation. Our form datasets will include original case report forms, a detailed codebook of variable names, value labels, and programming formats and all study documentation including the protocol and manual of procedures. For descriptive/raw data, study investigators/study staff will upload to NIMH's National Database for Clinical Trials Related to Mental Health Illness (NDCT) on a semi-annual basis all analyzed data being uploaded prior to primary paper publication.
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These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication
In addition to public access to the NDCT, data can also be accessed by contacting ETUDES Center investigators.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
1 intervention participant did not complete the entire Baseline assessment following consent and PHQ-9 assessment. A total of 67 intervention participants completed all Baseline measures. All 33 TAU participants completed all Baseline assessments.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | 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. | 6 intervention participants and 1 TAU participant did not complete the PHQ-9 and remain in the "intention to treat" analysis sample | Posted | Mean | Standard Deviation | score on a scale | At 4 week follow up after Baseline |
|
Adverse event data was collected over course of open enrollment and follow up data collection (11/05/2020 to 03/23/2022). Adverse event data was collected for each individual over 12 weeks that they were engaged in the study.
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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 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unanticipated problem-Breach of confidentiality | Psychiatric disorders | Non-systematic Assessment | Patient name was inadvertently sent to wrong study practice when they were randomized to intervention. Research staff notified the IRB and they felt no additional reporting was necessary and was unrelated to study intervention. |
The small sample size of this pilot study was selected for feasibility testing, not for hypothesis testing; thus, inferential tests were underpowered and conducted for exploratory purposes. It lacked a full control group we originally intended to collect. The impact of treatment on individuals who dropped out of treatment and on those lost during follow-up is unknown.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephanie Stepp | University of Pittsburgh | 412-715-5447 | steppsd@upmc.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 | Nov 30, 2021 | Aug 31, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 19, 2021 | Dec 2, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D059020 | Suicidal Ideation |
| D001008 | Anxiety Disorders |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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This study will use a parallel study design, where participants are randomized into two groups, BRITEPath or TAU, and will receive interventions in parallel.
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Outcomes assessors will be masked to the intervention condition at follow-up assessment time points.
|
| Treatment As Usual (TAU) | Behavioral | Participants in this group will receive usual care from their mental health care provider. |
|
| At 12 week follow up after Baseline |
| 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. | At 4 week follow up after Baseline |
| 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. | At 12 week follow up after Baseline |
| 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. | 4 week follow up |
| 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. | 12 week follow up |
| Up to 12 week follow up |
| 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. | Up to 12 week follow up |
| 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. | At 12 week follow up after Baseline |
| 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 | 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) |
| 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 | 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) |
| 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. | 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 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. | 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) |
| Hyde Park |
| New York |
| 11040 |
| United States |
| Children's Community Pediatrics (CCP-Moon) of Children's Hospital of Pittsburgh of UPMC | Moon Township | Pennsylvania | 15108 | United States |
| STAR- Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Children's Community Pediatrics (CCP- Wexford) of Children's Hospital of Pittsburgh of UPMC | Wexford | Pennsylvania | 15090 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Depression Severity | Total scores from the Patient Health Questionnaire (PHQ-9) assesses depression severity. The PHQ-9 is 9 items 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. PHQ collected at recruitment for eligibility, baseline, and follow up timepoints to track changes in depression severity over course of study. | Mean | Standard Deviation | score on a scale |
|
| 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. | The PEDS QOL measure is only administered to adolescents in the study, not those age 18+. There were young adult participants included in the study in each treatment arm. | Mean | Standard Deviation | score on a scale |
|
| Suicidal Ideation and Behavior | Suicidal attempt & ideation measured through Columbia Suicide Severity Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present, assign a score of 1 if ideation/behavior present. "Yes" to question 9 (score=1) on PHQ-9 indicates suicidal ideation. "Yes" to suicidal behavior questions (Categories 7-10): 7-Aborted Attempt 8-Interrupted Attempt 9-Actual Attempt (non-fatal) 10-Completed Suicide indicates respondent has suicidal behavior. Any score greater than 0 is important/may indicate need for intervention. | 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent. | Mean | Standard Deviation | score on a scale |
|
| 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. | 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent. | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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. | 9 intervention participants and 2 TAU participants did not complete the PHQ-9 and remain in the "intention to treat" analysis sample | Posted | Mean | Standard Deviation | score on a scale | At 12 week follow up after Baseline |
|
|
|
| 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. | 6 intervention participants and 1 TAU participant did not complete the C-SSRS and remain in the "intention to treat" analysis sample | Posted | Mean | Standard Deviation | score on a scale | At 4 week follow up after Baseline |
|
|
|
| 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. | 9 intervention participants and 2 TAU participants did not complete the C-SSRS and remain in the "intention to treat" analysis sample | Posted | Mean | Standard Deviation | score on a scale | At 12 week follow up after Baseline |
|
|
|
| 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. | Only adolescents under age 18 received the PEDS-QOL measure. | Posted | Mean | Standard Deviation | score on a scale | At 4 week follow up after Baseline |
|
|
|
| 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. | Only adolescents under age 18 received the PEDS-QOL measure. | Posted | Mean | Standard Deviation | score on a scale | At 12 week follow up after Baseline |
|
|
|
| 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. | 6 intervention participants did not complete week 4 assessment and 1 TAU participant did not complete week 4 assessment | Posted | Count of Participants | Participants | 4 week follow up |
|
|
|
| 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. | 9 intervention participants did not complete week 12 assessment and 2 TAU participants did not complete week 12 assessment | Posted | Count of Participants | Participants | 12 week follow up |
|
|
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| 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. | 68/68 participants received the intervention. | Posted | Count of Participants | Participants | Up to 12 week follow up |
|
|
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| 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. | 68/68 participants were onboarded by clinician. | Posted | Count of Participants | Participants | Up to 12 week follow up |
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| 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. | 68/68 participants received BRITEPath onboarding | Posted | Mean | Full Range | dollars per participant | At 12 week follow up after Baseline |
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|
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| 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 | 51 participants responded to 2 of the exit interview items and 50 participants responded to the 3rd exit interview item | Posted | Count of Participants | Participants | 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) |
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| 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 | 51 participants responded to 2 of the exit interview items and 50 participants responded to the 3rd exit interview item | Posted | Count of Participants | Participants | 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) |
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| 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. | 51 participants responded to 2 of the exit interview items and 50 participants responded to the 3rd exit interview item | Posted | Count of Participants | Participants | 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) |
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| 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. | Some participants did not respond to all questions in PSSUQ measure. | Posted | Mean | Standard Deviation | score on a scale | 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) |
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|
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| 0 |
| 68 |
| 0 |
| 68 |
| 1 |
| 68 |
| EG001 | 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. | 0 | 33 | 0 | 33 | 0 | 33 |
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Not provided
Not provided
| D001523 |
| Mental Disorders |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| C-SSRS Category 8: Interrupted Attempt |
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| C-SSRS Category 9: Actual Attempt (non-fatal) |
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| C-SSRS Category 10: Completed Suicide |
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| C-SSRS Category 8: Interrupted Attempt |
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| C-SSRS Category 9: Actual Attempt (non-fatal) |
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| C-SSRS Category 10: Completed Suicide |
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| PEDS QOL Social Score |
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| PEDS QOL Psychosocial Health Summary Score |
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| PEDS QOL Total Score |
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| PEDS QOL Social Score |
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| PEDS QOL Psychosocial Health Summary Score |
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| PEDS QOL Total Score |
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| Use emergency services |
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| Use legal services |
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| Use inpatient services |
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| Use medications |
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| Use emergency services |
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| Use legal services |
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| Use inpatient services |
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| Use medications |
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| Did not complete |
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| Learn to savor |
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| Reaching out to contacts |
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| Soothe Breathe |
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| Soothe Guided Meditation |
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| Crisis survival strategies |
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| Distract with happy thoughts |
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| Distract exercise |
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| Savor |
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| Soothe activities to help you sleep |
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| Did not complete |
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| Step 1.3 |
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| Step 2 |
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| Step 2.1 |
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| Step 2.2 |
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| Step 2.3 |
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| Step 2.4 |
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| Step 2.5 |
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| Step 3 |
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| Step 3.2 |
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| Step 4 |
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| Step 4.1 |
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| Step 5 |
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| Yes, definitely |
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| Very Satisfied |
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| Yes, a great deal |
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| The information provided with BRITE App such as notifications to rate my mood was clear |
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| The information provided during the onboarding with my therapist was clear |
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| I liked interacting with the BRITE app program |
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| I needed to learn a lot of things before I could get going with BRITE App |
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