Trial Outcomes & Findings for BRITEPath- Phase 2 (NCT NCT04672798)
NCT ID: NCT04672798
Last Updated: 2023-06-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
101 participants
Primary outcome timeframe
At 4 week follow up after Baseline
Results posted on
2023-06-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
33
|
|
Overall Study
COMPLETED
|
59
|
31
|
|
Overall Study
NOT COMPLETED
|
9
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
BRITEPath
n=68 Participants
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.
|
Treatment As Usual (TAU)
n=33 Participants
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.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=68 Participants
|
12 Participants
n=33 Participants
|
42 Participants
n=101 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=68 Participants
|
21 Participants
n=33 Participants
|
59 Participants
n=101 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=68 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=101 Participants
|
|
Sex/Gender, Customized
Male
|
15 Participants
n=68 Participants
|
4 Participants
n=33 Participants
|
19 Participants
n=101 Participants
|
|
Sex/Gender, Customized
Female
|
43 Participants
n=68 Participants
|
24 Participants
n=33 Participants
|
67 Participants
n=101 Participants
|
|
Sex/Gender, Customized
Female to Male Transgender
|
2 Participants
n=68 Participants
|
0 Participants
n=33 Participants
|
2 Participants
n=101 Participants
|
|
Sex/Gender, Customized
Non-binary/ Queer
|
8 Participants
n=68 Participants
|
4 Participants
n=33 Participants
|
12 Participants
n=101 Participants
|
|
Sex/Gender, Customized
Other Gender
|
0 Participants
n=68 Participants
|
1 Participants
n=33 Participants
|
1 Participants
n=101 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=68 Participants
|
3 Participants
n=33 Participants
|
7 Participants
n=101 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=68 Participants
|
30 Participants
n=33 Participants
|
93 Participants
n=101 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=68 Participants
|
0 Participants
n=33 Participants
|
1 Participants
n=101 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=101 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=68 Participants
|
0 Participants
n=33 Participants
|
4 Participants
n=101 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=101 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=68 Participants
|
2 Participants
n=33 Participants
|
10 Participants
n=101 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=68 Participants
|
26 Participants
n=33 Participants
|
71 Participants
n=101 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=68 Participants
|
3 Participants
n=33 Participants
|
7 Participants
n=101 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=68 Participants
|
2 Participants
n=33 Participants
|
9 Participants
n=101 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=68 Participants
|
33 participants
n=33 Participants
|
101 participants
n=101 Participants
|
|
Depression Severity
|
10.6 score on a scale
STANDARD_DEVIATION 5.9 • n=68 Participants
|
11.4 score on a scale
STANDARD_DEVIATION 5.7 • n=33 Participants
|
10.9 score on a scale
STANDARD_DEVIATION 5.9 • n=101 Participants
|
|
Quality of life and Social/Emotional Functioning
PEDS QOL Physical Score
|
81.7 score on a scale
STANDARD_DEVIATION 20 • n=21 Participants • 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.
|
70.5 score on a scale
STANDARD_DEVIATION 18 • n=10 Participants • 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.
|
78.1 score on a scale
STANDARD_DEVIATION 19.8 • n=31 Participants • 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.
|
|
Quality of life and Social/Emotional Functioning
PEDS QOL Emotional Score
|
59 score on a scale
STANDARD_DEVIATION 27.1 • n=21 Participants • 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.
|
50 score on a scale
STANDARD_DEVIATION 18.4 • n=10 Participants • 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.
|
56.1 score on a scale
STANDARD_DEVIATION 24.7 • n=31 Participants • 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.
|
|
Quality of life and Social/Emotional Functioning
PEDS QOL Social Score
|
77.4 score on a scale
STANDARD_DEVIATION 23.7 • n=21 Participants • 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.
|
69.8 score on a scale
STANDARD_DEVIATION 27.9 • n=10 Participants • 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.
|
74.9 score on a scale
STANDARD_DEVIATION 25 • n=31 Participants • 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.
|
|
Quality of life and Social/Emotional Functioning
PEDS QOL Psychosocial Health Summary Score
|
66.6 score on a scale
STANDARD_DEVIATION 22.9 • n=21 Participants • 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.
|
56.9 score on a scale
STANDARD_DEVIATION 13.8 • n=10 Participants • 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.
|
63.5 score on a scale
STANDARD_DEVIATION 20.7 • n=31 Participants • 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.
|
|
Quality of life and Social/Emotional Functioning
PEDS QOL Total Score
|
71.8 score on a scale
STANDARD_DEVIATION 20.4 • n=21 Participants • 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.
|
61.6 score on a scale
STANDARD_DEVIATION 14.6 • n=10 Participants • 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.
|
68.5 score on a scale
STANDARD_DEVIATION 19.1 • n=31 Participants • 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.
|
|
Suicidal Ideation and Behavior
PHQ-9-question #9
|
0.5 score on a scale
STANDARD_DEVIATION 0.8 • n=68 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
0.4 score on a scale
STANDARD_DEVIATION 0.8 • n=33 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
0.5 score on a scale
STANDARD_DEVIATION 0.8 • n=101 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
|
Suicidal Ideation and Behavior
C-SSRS Category 7: Aborted Attempts
|
0 score on a scale
STANDARD_DEVIATION 0.2 • n=67 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
0 score on a scale
STANDARD_DEVIATION 0 • n=33 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
0.0 score on a scale
STANDARD_DEVIATION 0.2 • n=100 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
|
Suicidal Ideation and Behavior
C-SSRS Category 8: Interrupted Attempts
|
0 score on a scale
STANDARD_DEVIATION 0.1 • n=67 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
0 score on a scale
STANDARD_DEVIATION 0.2 • n=33 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
0.0 score on a scale
STANDARD_DEVIATION 0.1 • n=100 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
|
Suicidal Ideation and Behavior
C-SSRS Category 9: Actual Attempts (non-lethal)
|
0.1 score on a scale
STANDARD_DEVIATION 0.3 • n=67 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
0 score on a scale
STANDARD_DEVIATION 0 • n=33 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
0.1 score on a scale
STANDARD_DEVIATION 0.3 • n=100 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
|
Suicidal Ideation and Behavior
C-SSRS Category 10: Completed Suicide
|
0 score on a scale
STANDARD_DEVIATION 0 • n=67 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
0 score on a scale
STANDARD_DEVIATION 0 • n=33 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
0.0 score on a scale
STANDARD_DEVIATION 0.0 • n=100 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use of Outpatient Services
|
61 Participants
n=67 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
29 Participants
n=33 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
90 Participants
n=100 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use of School Services
|
36 Participants
n=67 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
20 Participants
n=33 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
56 Participants
n=100 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use of Emergency Services
|
11 Participants
n=67 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
3 Participants
n=33 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
14 Participants
n=100 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use of Legal Services
|
0 Participants
n=67 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
1 Participants
n=33 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
1 Participants
n=100 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use of Inpatient Services
|
18 Participants
n=67 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
7 Participants
n=33 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
25 Participants
n=100 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use of Medications
|
57 Participants
n=67 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
26 Participants
n=33 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
83 Participants
n=100 Participants • 1 participant only completed demographics and PHQ-9 measure at Baseline after completed consent.
|
PRIMARY outcome
Timeframe: At 4 week follow up after BaselinePopulation: 6 intervention participants and 1 TAU participant did not complete the PHQ-9 and remain in the "intention to treat" analysis sample
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.
Outcome measures
| Measure |
BRITEPath
n=62 Participants
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.
|
Treatment As Usual (TAU)
n=32 Participants
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.
|
|---|---|---|
|
Depression Severity
|
8.6 score on a scale
Standard Deviation 5.6
|
10.8 score on a scale
Standard Deviation 5.4
|
PRIMARY outcome
Timeframe: At 12 week follow up after BaselinePopulation: 9 intervention participants and 2 TAU participants did not complete the PHQ-9 and remain in the "intention to treat" analysis sample
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.
Outcome measures
| Measure |
BRITEPath
n=59 Participants
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.
|
Treatment As Usual (TAU)
n=31 Participants
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.
|
|---|---|---|
|
Depression Severity
|
8.3 score on a scale
Standard Deviation 5.4
|
10 score on a scale
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: At 4 week follow up after BaselinePopulation: 6 intervention participants and 1 TAU participant did not complete the C-SSRS and remain in the "intention to treat" analysis sample
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.
Outcome measures
| Measure |
BRITEPath
n=62 Participants
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.
|
Treatment As Usual (TAU)
n=32 Participants
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.
|
|---|---|---|
|
Suicidal Ideation and Behavior
PHQ-9 question #9
|
0.3 score on a scale
Standard Deviation 0.7
|
0.5 score on a scale
Standard Deviation 0.9
|
|
Suicidal Ideation and Behavior
C-SSRS Category 7: Aborted Attempt
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Suicidal Ideation and Behavior
C-SSRS Category 8: Interrupted Attempt
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Suicidal Ideation and Behavior
C-SSRS Category 9: Actual Attempt (non-fatal)
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Suicidal Ideation and Behavior
C-SSRS Category 10: Completed Suicide
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At 12 week follow up after BaselinePopulation: 9 intervention participants and 2 TAU participants did not complete the C-SSRS and remain in the "intention to treat" analysis sample
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.
Outcome measures
| Measure |
BRITEPath
n=59 Participants
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.
|
Treatment As Usual (TAU)
n=31 Participants
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.
|
|---|---|---|
|
Suicidal Ideation and Behavior
PHQ-9 Question 9 (ideation)
|
0.2 score on a scale
Standard Deviation 0.5
|
0.4 score on a scale
Standard Deviation 0.7
|
|
Suicidal Ideation and Behavior
C-SSRS Category 7: Aborted Attempt
|
0 score on a scale
Standard Deviation 0.2
|
0 score on a scale
Standard Deviation 0
|
|
Suicidal Ideation and Behavior
C-SSRS Category 8: Interrupted Attempt
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Suicidal Ideation and Behavior
C-SSRS Category 9: Actual Attempt (non-fatal)
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Suicidal Ideation and Behavior
C-SSRS Category 10: Completed Suicide
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At 4 week follow up after BaselinePopulation: Only adolescents under age 18 received the PEDS-QOL measure.
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.
Outcome measures
| Measure |
BRITEPath
n=19 Participants
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.
|
Treatment As Usual (TAU)
n=9 Participants
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.
|
|---|---|---|
|
Quality of Life and Social/Emotional Functioning
PEDS QOL Physical Score
|
89.3 score on a scale
Standard Deviation 11.5
|
71.5 score on a scale
Standard Deviation 22.5
|
|
Quality of Life and Social/Emotional Functioning
PEDS QOL Emotional Score
|
68.7 score on a scale
Standard Deviation 25.9
|
60.6 score on a scale
Standard Deviation 20.8
|
|
Quality of Life and Social/Emotional Functioning
PEDS QOL Social Score
|
81.6 score on a scale
Standard Deviation 24.1
|
76.1 score on a scale
Standard Deviation 25.8
|
|
Quality of Life and Social/Emotional Functioning
PEDS QOL Psychosocial Health Summary Score
|
73.5 score on a scale
Standard Deviation 21.6
|
64.4 score on a scale
Standard Deviation 19.9
|
|
Quality of Life and Social/Emotional Functioning
PEDS QOL Total Score
|
79 score on a scale
Standard Deviation 16.4
|
67 score on a scale
Standard Deviation 20.4
|
PRIMARY outcome
Timeframe: At 12 week follow up after BaselinePopulation: Only adolescents under age 18 received the PEDS-QOL measure.
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.
Outcome measures
| Measure |
BRITEPath
n=19 Participants
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.
|
Treatment As Usual (TAU)
n=9 Participants
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.
|
|---|---|---|
|
Quality of Life and Social/Emotional Functioning
PEDS QOL Physical Score
|
87.2 score on a scale
Standard Deviation 15.2
|
74 score on a scale
Standard Deviation 20.4
|
|
Quality of Life and Social/Emotional Functioning
PEDS QOL Emotional Score
|
63.7 score on a scale
Standard Deviation 25.4
|
50.6 score on a scale
Standard Deviation 20.7
|
|
Quality of Life and Social/Emotional Functioning
PEDS QOL Social Score
|
82.6 score on a scale
Standard Deviation 27.6
|
72.2 score on a scale
Standard Deviation 29.4
|
|
Quality of Life and Social/Emotional Functioning
PEDS QOL Psychosocial Health Summary Score
|
72.8 score on a scale
Standard Deviation 23.2
|
61.7 score on a scale
Standard Deviation 16.4
|
|
Quality of Life and Social/Emotional Functioning
PEDS QOL Total Score
|
77.8 score on a scale
Standard Deviation 19.3
|
65.9 score on a scale
Standard Deviation 16.4
|
PRIMARY outcome
Timeframe: 4 week follow upPopulation: 6 intervention participants did not complete week 4 assessment and 1 TAU participant did not complete week 4 assessment
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.
Outcome measures
| Measure |
BRITEPath
n=62 Participants
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.
|
Treatment As Usual (TAU)
n=32 Participants
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.
|
|---|---|---|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use outpatient services
|
45 Participants
|
25 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use school services
|
5 Participants
|
2 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use emergency services
|
0 Participants
|
0 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use legal services
|
0 Participants
|
0 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use inpatient services
|
1 Participants
|
0 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use medications
|
33 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: 12 week follow upPopulation: 9 intervention participants did not complete week 12 assessment and 2 TAU participants did not complete week 12 assessment
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.
Outcome measures
| Measure |
BRITEPath
n=59 Participants
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.
|
Treatment As Usual (TAU)
n=31 Participants
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.
|
|---|---|---|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use medications
|
32 Participants
|
14 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use outpatient services
|
45 Participants
|
23 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use school services
|
4 Participants
|
1 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use emergency services
|
0 Participants
|
0 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use legal services
|
0 Participants
|
0 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Use inpatient services
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 week follow upPopulation: 68/68 participants received the intervention.
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.
Outcome measures
| Measure |
BRITEPath
n=68 Participants
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.
|
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.
|
|---|---|---|
|
Application Utilization-BRITE App Use by Participants
Distract exercise · Completed
|
13 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
First distress level · Completed
|
37 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
First distress level · Did not complete
|
31 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Second distress level · Completed
|
29 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Second distress level · Did not complete
|
39 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Learn to savor · Completed
|
4 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Learn to savor · Did not complete
|
64 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Reaching out to contacts · Completed
|
11 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Reaching out to contacts · Did not complete
|
57 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Soothe Breathe · Completed
|
17 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Soothe Breathe · Did not complete
|
51 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Soothe Guided Meditation · Completed
|
9 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Soothe Guided Meditation · Did not complete
|
59 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Crisis survival strategies · Completed
|
14 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Crisis survival strategies · Did not complete
|
54 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Distract with happy thoughts · Completed
|
17 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Distract with happy thoughts · Did not complete
|
51 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Distract exercise · Did not complete
|
55 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Savor · Completed
|
15 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Savor · Did not complete
|
53 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Soothe activities to help you sleep · Completed
|
10 Participants
|
—
|
|
Application Utilization-BRITE App Use by Participants
Soothe activities to help you sleep · Did not complete
|
58 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 12 week follow upPopulation: 68/68 participants were onboarded by clinician.
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.
Outcome measures
| Measure |
BRITEPath
n=68 Participants
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.
|
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.
|
|---|---|---|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 1 · Completed
|
41 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 1 · Did not complete
|
27 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 1.2 · Completed
|
41 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 1.2 · Did not complete
|
27 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 1.3 · Completed
|
41 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 1.3 · Did not complete
|
27 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 2 · Completed
|
0 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 2 · Did not complete
|
68 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 2.1 · Completed
|
41 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 2.1 · Did not complete
|
27 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 2.2 · Completed
|
41 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 2.2 · Did not complete
|
27 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 2.3 · Completed
|
41 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 2.3 · Did not complete
|
27 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 2.4 · Completed
|
41 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 2.4 · Did not complete
|
27 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 2.5 · Completed
|
41 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 2.5 · Did not complete
|
27 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 3 · Completed
|
41 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 3 · Did not complete
|
27 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 3.2 · Completed
|
41 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 3.2 · Did not complete
|
27 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 4 · Completed
|
0 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 4 · Did not complete
|
68 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 4.1 · Completed
|
40 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 4.1 · Did not complete
|
28 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 5 · Completed
|
2 Participants
|
—
|
|
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Step 5 · Did not complete
|
66 Participants
|
—
|
SECONDARY outcome
Timeframe: At 12 week follow up after BaselinePopulation: 68/68 participants received BRITEPath onboarding
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.
Outcome measures
| Measure |
BRITEPath
n=68 Participants
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.
|
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.
|
|---|---|---|
|
Cost Estimate for Implementation of BRITEPath Intervention
|
457.43 dollars per participant
Interval 214.1 to 597.05
|
—
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
BRITEPath
n=51 Participants
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.
|
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.
|
|---|---|---|
|
Usability and Satisfaction
No, definitely not
|
8 Participants
|
—
|
|
Usability and Satisfaction
No don't think so
|
8 Participants
|
—
|
|
Usability and Satisfaction
Yes, I think so
|
19 Participants
|
—
|
|
Usability and Satisfaction
Yes, definitely
|
16 Participants
|
—
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
BRITEPath
n=51 Participants
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.
|
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.
|
|---|---|---|
|
Usability and Satisfaction
Very Dissatisfied
|
5 Participants
|
—
|
|
Usability and Satisfaction
Dissatisfied
|
6 Participants
|
—
|
|
Usability and Satisfaction
Satisfied
|
30 Participants
|
—
|
|
Usability and Satisfaction
Very Satisfied
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
BRITEPath
n=50 Participants
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.
|
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.
|
|---|---|---|
|
Usability and Satisfaction
Seemed to make things worse
|
2 Participants
|
—
|
|
Usability and Satisfaction
Really didn't help
|
11 Participants
|
—
|
|
Usability and Satisfaction
Yes, somewhat
|
26 Participants
|
—
|
|
Usability and Satisfaction
Yes, a great deal
|
11 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
BRITEPath
n=51 Participants
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.
|
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.
|
|---|---|---|
|
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
|
—
|
|
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
|
—
|
|
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
|
—
|
|
Satisfaction With Technical Components
The information provided during the onboarding with my therapist was clear
|
5.3 score on a scale
Standard Deviation 2
|
—
|
|
Satisfaction With Technical Components
I liked interacting with the BRITE app program
|
4.6 score on a scale
Standard Deviation 1.9
|
—
|
|
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
|
—
|
Adverse Events
BRITEPath
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment As Usual (TAU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BRITEPath
n=68 participants at risk
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.
|
Treatment As Usual (TAU)
n=33 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Unanticipated problem-Breach of confidentiality
|
1.5%
1/68 • Number of events 1 • 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.
|
0.00%
0/33 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place