An interventional study of BRITEPath in Depression and Suicidal Ideation, sponsored by University of Pittsburgh. Completed at 6 sites in United States. Open to participants aged 12 Years to 26 Years. Per ClinicalTrials.gov, last updated 2022-08-08.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research
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.
Delivery of Interventions:
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 utilized an open trial design. A stepped wedge design was originally proposed and efforts were made to adhere to this study design, however after a year of low recruitment and resultant recruitment sites pulling out the of the study, the overall study design was changed to an open trial. Additional recruitment sites were onboarded to the study and provided with the intervention arm in order to obtain feasibility data on the intervention components of the study. As a result of the change, there are some TAU participants included in this study. For reference a stepped wedge design involves the sequential random rollout of an intervention over two time periods. Following a baseline period in which no clusters (=practices) are exposed to the intervention, the crossover is typically in one direction, from control to intervention and continues until both of the clusters have crossed-over to receive the intervention, with observations taken from each cluster and at each time period.
Study investigators will pilot BRITEPath in community pediatric and mental health practices using a stepped wedge design (n =50 adolescents).
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.
Of note: Study investigators initially intended to do a cost analysis as a secondary outcome measure, but it was later decided that the analysis will not be done in this pilot phase of testing and will instead be completed during the Phase 2 RCT.
515 studies on the registry are indexed under Suicidal Ideation; 195 are open to participants now.
This study's enrollment of 43 is below the median of 80 across 426 interventional studies indexed under Suicidal Ideation.
Browse Suicidal Ideation studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Non English speaking No parent willing to provide informed consent No cell phone capability of downloading BRITE app Is currently experiencing mania or psychosis Evidence of an intellectual or developmental disorder (IDD) Life threatening medical condition that requires immediate treatment (included emergent suicidality, homicidality, abuse/neglect, or other mental or physical condition) Other cognitive or medical condition preventing youth from understanding study and/or participating.
Currently receiving MH treatment/currently satisfied with treatment
Participants will receive the components in BRITEPath from a mental health (MH) clinician 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.
Behavioral: 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.
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 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.
Time frame: At Baseline phone visit
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 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.
Time frame: 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 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.
Time frame: At 12 week follow up after Baseline
Suicidal Ideation and Behavior
Suicidal attempt \& ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS) and the Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present and assign a score of 1 if ideation/behavior present. A "yes" answer any time during treatment to question 9 on the PHQ-9 indicates suicidal ideation. A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 7-10) on the C-SSRS. C-SSRS Categories 7-10 are as follows: 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.
Time frame: At Baseline phone visit
Suicidal Ideation and Behavior
Suicidal attempt \& ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS) and the Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present and assign a score of 1 if ideation/behavior present. A "yes" answer any time during treatment to question 9 on the PHQ-9 indicates suicidal ideation. A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 7-10) on the C-SSRS. C-SSRS Categories 7-10 are as follows: 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.
Time frame: At 4 week follow up after Baseline
Suicidal Ideation and Behavior
Suicidal attempt \& ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS) and the Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present and assign a score of 1 if ideation/behavior present. A "yes" answer any time during treatment to question 9 on the PHQ-9 indicates suicidal ideation. A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 7-10) on the C-SSRS. C-SSRS Categories 7-10 are as follows: 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.
Time frame: At 12 week follow up after Baseline
Quality of Life and Social/Emotional Functioning
The Pediatric Quality of Life Inventory Version 4.0 (PedsQOL) will be used to assess overall quality of life and functioning, as a primary outcome. The PEDSQOL has 23 items and ranges in score from 0-92. It is broken down into 4 subdomains of physical functioning, emotional functioning, social functioning, and work/school (psychosocial) functioning. The higher the score, the more problems the respondent associates with the prompt/sub domain.
Time frame: At Baseline phone visit
Quality of Life and Social/Emotional Functioning
The Pediatric Quality of Life Inventory Version 4.0 (PedsQOL) will be used to assess overall quality of life and functioning, as a primary outcome. The PEDSQOL has 23 items and ranges in score from 0-92. It is broken down into 4 subdomains of physical functioning, emotional functioning, social functioning, and work/school (psychosocial) functioning. The higher the score, the more problems the respondent associates with the prompt/sub domain.
Time frame: At 4 week follow up after Baseline
Quality of Life and Social/Emotional Functioning
The Pediatric Quality of Life Inventory Version 4.0 (PedsQOL) will be used to assess overall quality of life and functioning, as a primary outcome. The PEDSQOL has 23 items and ranges in score from 0-92. It is broken down into 4 subdomains of physical functioning, emotional functioning, social functioning, and work/school (psychosocial) functioning. The higher the score, the more problems the respondent associates with the prompt/sub domain.
Time frame: At 12 week follow up after Baseline
Application Utilization
Use of the technical components of the BRITEApp for adolescents and young adults will be monitored throughout Phase 1b. 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
Application Utilization
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.
Time frame: Up to 12 week follow-up
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at Baseline
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
Time frame: At Baseline phone visit
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow Up
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
Time frame: At 4 week follow up after Baseline
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow Up
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
Time frame: 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? with answer options of: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely How satisfied are you with the amount of help you received? with answer options of: Dissatisfied; Satisfied; Very Satisfied Have the services you received helped you to deal more effectively with your problems? with answer options of: Really didn't help; Yes, somewhat; 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)
Usability and Satisfaction
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)
Cost Estimate for Implementation of BRITEPath Intervention
An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) 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
| Milestone | BritePath | Treatment As Usual (TAU) |
|---|---|---|
| Started | 38 | 5 |
| Completed | 38 | 5 |
| Not completed | 0 | 0 |
Total scores from the Patient Health Questionnaire (PHQ-9) will be used to assess depression severity, as a primary outcome. 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.
| score on a scale | BritePath | Treatment As Usual (TAU) |
|---|---|---|
| Depression Severity | 12.9 ± 4.8 | 9.2 ± 5.8 |
Total scores from the Patient Health Questionnaire (PHQ-9) will be used to assess depression severity, as a primary outcome. 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.
| score on a scale | BritePath | Treatment As Usual (TAU) |
|---|---|---|
| Depression Severity | 10.9 ± 6 | 5.5 ± 1.3 |
Total scores from the Patient Health Questionnaire (PHQ-9) will be used to assess depression severity, as a primary outcome. 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.
| score on a scale | BritePath | Treatment As Usual (TAU) |
|---|---|---|
| Depression Severity | 10.4 ± 5.4 | 9.5 ± 1.7 |
Suicidal attempt \& ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS) and the Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present and assign a score of 1 if ideation/behavior present. A "yes" answer any time during treatment to question 9 on the PHQ-9 indicates suicidal ideation. A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 7-10) on the C-SSRS. C-SSRS Categories 7-10 are as follows: 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.
| score on a scale | BritePath | Treatment As Usual (TAU) |
|---|---|---|
| PHQ-9 Question 9 (ideation) | 1.1 ± 1 | 0 ± 0 |
| C-SSRS Category 7: Aborted Attempt | 0.1 ± 0.2 | 0 ± 0 |
| C-SSRS Category 8: Interrupted Attempt | 0 ± 0 | 0 ± 0 |
| C-SSRS Category 9: Actual Attempt (non-fatal) | 0.1 ± 0.3 | 0 ± 0 |
| C-SSRS Category 10: Completed Suicide | 0 ± 0 | 0 ± 0 |
Suicidal attempt \& ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS) and the Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present and assign a score of 1 if ideation/behavior present. A "yes" answer any time during treatment to question 9 on the PHQ-9 indicates suicidal ideation. A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 7-10) on the C-SSRS. C-SSRS Categories 7-10 are as follows: 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.
| score on a scale | BritePath | Treatment As Usual (TAU) |
|---|---|---|
| PHQ-9 Question 9 (ideation) | 0.9 ± 1 | 0 ± 0 |
| C-SSRS Category 7: Aborted Attempts | 0 ± 0 | 0 ± 0 |
| C-SSRS Category 8: Interrupted Attempts | 0 ± 0.2 | 0 ± 0 |
| C-SSRS Category 9: Actual Attempts (non-lethal) | 0.1 ± 0.2 | 0 ± 0 |
| C-SSRS Category 10: Completed Suicide | 0 ± 0 | 0 ± 0 |
Suicidal attempt \& ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS) and the Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present and assign a score of 1 if ideation/behavior present. A "yes" answer any time during treatment to question 9 on the PHQ-9 indicates suicidal ideation. A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 7-10) on the C-SSRS. C-SSRS Categories 7-10 are as follows: 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.
| score on a scale | BritePath | Treatment As Usual (TAU) |
|---|---|---|
| PHQ-9 Question 9 (ideation) | 0.6 ± 0.8 | 0 ± 0 |
| C-SSRS Category 7: Aborted Attempts | 0 ± 0 | 0 ± 0 |
| C-SSRS Category 8: Interrupted Attempts | 0.1 ± 0.2 | 0 ± 0 |
| C-SSRS Category 9: Actual Attempts (non-lethal) | 0 ± 0 | 0 ± 0 |
| C-SSRS Category 10: Completed Suicide | 0 ± 0 | 0 ± 0 |
The Pediatric Quality of Life Inventory Version 4.0 (PedsQOL) will be used to assess overall quality of life and functioning, as a primary outcome. The PEDSQOL has 23 items and ranges in score from 0-92. It is broken down into 4 subdomains of physical functioning, emotional functioning, social functioning, and work/school (psychosocial) functioning. The higher the score, the more problems the respondent associates with the prompt/sub domain.
| score on a scale | BritePath | Treatment As Usual (TAU) |
|---|---|---|
| Quality of Life and Social/Emotional Functioning | 63.1 ± 12.2 | 70.9 ± 18.4 |
The Pediatric Quality of Life Inventory Version 4.0 (PedsQOL) will be used to assess overall quality of life and functioning, as a primary outcome. The PEDSQOL has 23 items and ranges in score from 0-92. It is broken down into 4 subdomains of physical functioning, emotional functioning, social functioning, and work/school (psychosocial) functioning. The higher the score, the more problems the respondent associates with the prompt/sub domain.
| score on a scale | BritePath | Treatment As Usual (TAU) |
|---|---|---|
| Quality of Life and Social/Emotional Functioning | 71 ± 11.8 | 64.8 ± 12 |
The Pediatric Quality of Life Inventory Version 4.0 (PedsQOL) will be used to assess overall quality of life and functioning, as a primary outcome. The PEDSQOL has 23 items and ranges in score from 0-92. It is broken down into 4 subdomains of physical functioning, emotional functioning, social functioning, and work/school (psychosocial) functioning. The higher the score, the more problems the respondent associates with the prompt/sub domain.
| score on a scale | BritePath | Treatment As Usual (TAU) |
|---|---|---|
| Quality of Life and Social/Emotional Functioning | 72.6 ± 11.5 | 65.5 ± 13 |
Use of the technical components of the BRITEApp for adolescents and young adults will be monitored throughout Phase 1b. 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.
| Participants | BRITEPath |
|---|---|
| First distress level — Completed | 24 |
| First distress level — Did not complete | 14 |
| Second distress level — Completed | 17 |
| Second distress level — Did not complete | 21 |
| Learn to savor — Completed | 2 |
| Learn to savor — Did not complete | 36 |
| Reaching out to contacts — Completed | 9 |
| Reaching out to contacts — Did not complete | 29 |
| Soothe breathe — Completed | 8 |
| Soothe breathe — Did not complete | 30 |
| Soothe guided meditation — Completed | 6 |
| Soothe guided meditation — Did not complete | 32 |
| Crisis survival strategies — Completed | 9 |
| Crisis survival strategies — Did not complete | 29 |
| Distract with happy thoughts — Completed | 8 |
| Distract with happy thoughts — Did not complete | 30 |
| Distract exercise — Completed | 4 |
| Distract exercise — Did not complete | 34 |
| Savor — Completed | 5 |
| Savor — Did not complete | 33 |
| Soothe activities to help you sleep — Completed | 3 |
| Soothe activities to help you sleep — Did not complete | 35 |
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.
| Participants | BRITEPath |
|---|---|
| Step 1 — Completed | 28 |
| Step 1 — Did not complete | 10 |
| Step 1.2 — Completed | 28 |
| Step 1.2 — Did not complete | 10 |
| Step 1.3 — Completed | 34 |
| Step 1.3 — Did not complete | 4 |
| Step 2 — Completed | 38 |
| Step 2 — Did not complete | 0 |
| Step 2.1 — Completed | 34 |
| Step 2.1 — Did not complete | 4 |
| Step 2.2 — Completed | 34 |
| Step 2.2 — Did not complete | 4 |
| Step 2.3 — Completed | 34 |
| Step 2.3 — Did not complete | 4 |
| Step 2.4 — Completed | 34 |
| Step 2.4 — Did not complete | 4 |
| Step 2.5 — Completed | 34 |
| Step 2.5 — Did not complete | 4 |
| Step 3 — Completed | 33 |
| Step 3 — Did not complete | 5 |
| Step 3.2 — Completed | 32 |
| Step 3.2 — Did not complete | 6 |
| Step 4 — Completed | 38 |
| Step 4 — Did not complete | 0 |
| Step 4.1 — Completed | 31 |
| Step 4.1 — Did not complete | 7 |
| Step 5 — Completed | 15 |
| Step 5 — Did not complete | 23 |
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
| Participants | BRITEPath | Treatment As Usual |
|---|---|---|
| Use outpatient services | 32 | 4 |
| Use school services | 18 | 4 |
| Use ER services | 12 | 0 |
| Use legal services | 0 | 0 |
| Use inpatient services | 8 | 0 |
| Use medications | 31 | 2 |
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
| Participants | BritePath | Treatment As Usual (TAU) |
|---|---|---|
| Use outpatient services | 31 | 4 |
| Use school services | 19 | 4 |
| Use ER services | 12 | 0 |
| Use legal services | 0 | 0 |
| Use inpatient services | 8 | 0 |
| Use medications | 31 | 2 |
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
| Participants | BritePath | Treatment As Usual (TAU) |
|---|---|---|
| Use outpatient services | 29 | 2 |
| Use school services | 4 | 0 |
| Use ER services | 0 | 0 |
| Use legal services | 0 | 0 |
| Use inpatient services | 1 | 0 |
| Use medications | 26 | 2 |
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? with answer options of: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely How satisfied are you with the amount of help you received? with answer options of: Dissatisfied; Satisfied; Very Satisfied Have the services you received helped you to deal more effectively with your problems? with answer options of: Really didn't help; Yes, somewhat; Yes, a great deal.
| Participants | BRITEPath |
|---|---|
| If a friend were in need of mental health care, would you recommend BRITEPath? — No, I don't think so | 3 |
| If a friend were in need of mental health care, would you recommend BRITEPath? — Yes, I think so | 14 |
| If a friend were in need of mental health care, would you recommend BRITEPath? — Yes, definitely | 9 |
| If a friend were in need of mental health care, would you recommend BRITEPath? — Dissatisfied | 0 |
| If a friend were in need of mental health care, would you recommend BRITEPath? — Satisfied | 0 |
| If a friend were in need of mental health care, would you recommend BRITEPath? — Very Satisfied | 0 |
| If a friend were in need of mental health care, would you recommend BRITEPath? — Really didn't help | 0 |
| If a friend were in need of mental health care, would you recommend BRITEPath? — Yes, somewhat | 0 |
| If a friend were in need of mental health care, would you recommend BRITEPath? — Yes, a great deal | 0 |
| How satisfied were you with the amount of help you received? — No, I don't think so | 0 |
| How satisfied were you with the amount of help you received? — Yes, I think so | 0 |
| How satisfied were you with the amount of help you received? — Yes, definitely | 0 |
| How satisfied were you with the amount of help you received? — Dissatisfied | 1 |
| How satisfied were you with the amount of help you received? — Satisfied | 18 |
| How satisfied were you with the amount of help you received? — Very Satisfied | 7 |
| How satisfied were you with the amount of help you received? — Really didn't help | 0 |
| How satisfied were you with the amount of help you received? — Yes, somewhat | 0 |
| How satisfied were you with the amount of help you received? — Yes, a great deal | 0 |
| Have the services you received help you to deal more effectively with your problem? — No, I don't think so | 0 |
| Have the services you received help you to deal more effectively with your problem? — Yes, I think so | 0 |
| Have the services you received help you to deal more effectively with your problem? — Yes, definitely | 0 |
| Have the services you received help you to deal more effectively with your problem? — Dissatisfied | 0 |
| Have the services you received help you to deal more effectively with your problem? — Satisfied | 0 |
| Have the services you received help you to deal more effectively with your problem? — Very Satisfied | 0 |
| Have the services you received help you to deal more effectively with your problem? — Really didn't help | 2 |
| Have the services you received help you to deal more effectively with your problem? — Yes, somewhat | 20 |
| Have the services you received help you to deal more effectively with your problem? — Yes, a great deal | 4 |
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.
| score on a scale | BRITEPath |
|---|---|
| Overall, I am satisfied with how easy it is to use the BRITE app | 5.7 ± 1.4 |
| The information provided with the BRITE app was clear | 6.2 ± 1.2 |
| The information provided in the BRITE app such as notifications to rate my mood was clear | 6.1 ± 1 |
| The information provided during the onboarding with my therapist was clear | 6.5 ± 0.8 |
| I liked interacting with the BRITE app program | 5.8 ± 1 |
| I needed to learn a lot of things before I could get going with the BRITE app | 1.8 ± 1.2 |
An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) 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.
| dollars per participant | BRITEPath Intervention |
|---|---|
| Cost Estimate for Implementation of BRITEPath Intervention | 457.43 (214.10 to 597.05) |
Collected over Participants were assessed for adverse events at each timepoint (baseline, 4 week follow-up, 12 week follow-up).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BritePath | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
| Treatment As Usual (TAU) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
Measure Analysis Population Description: 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline or follow up visits where the rest of our demographic information is collected. These 3 pts also engaged in use of the app/intervention.
| Age, Categorical(Participants) | BritePath | Treatment As Usual (TAU) | Total |
|---|---|---|---|
| <=18 years | 31 | 5 | 36 |
| Between 18 and 65 years | 7 | 0 | 7 |
| >=65 years | 0 | 0 | 0 |
| Sex/Gender, Customized(Participants) | BritePath | Treatment As Usual (TAU) | Total |
|---|---|---|---|
| Male | 8 | 1 | 9 |
| Female | 26 | 4 | 30 |
| Non-binary/ Queer | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | BritePath | Treatment As Usual (TAU) | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 0 | 7 |
| Not Hispanic or Latino | 28 | 5 | 33 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | BritePath | Treatment As Usual (TAU) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 1 | 0 | 1 |
| White | 25 | 4 | 29 |
| More than one race | 2 | 0 | 2 |
| Unknown or Not Reported | 4 | 1 | 5 |
| Region of Enrollment(participants) | BritePath | Treatment As Usual (TAU) | Total |
|---|---|---|---|
| United States | 38 | 5 | 43 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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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University of Pittsburgh