Trial Outcomes & Findings for BRITEPath, Component 3 of iCHART (Integrated Care to Help At-Risk Teens) (NCT NCT04000399)
NCT ID: NCT04000399
Last Updated: 2022-08-08
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 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.
COMPLETED
NA
43 participants
At Baseline phone visit
2022-08-08
Participant Flow
Some participants were assigned to the single arm/group originally specified in the protocol and started Treatment as Usual but, due to a protocol amendment, these participants were not crossed over, and all subsequent participants were assigned to the BritePath intervention only. Thus we consider this a single arm study.
Participant milestones
| Measure |
BritePath
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.
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 not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
5
|
|
Overall Study
COMPLETED
|
38
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
Baseline characteristics by cohort
| Measure |
BritePath
n=38 Participants
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.
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=5 Participants
Participants in the TAU group will not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
31 Participants
n=38 Participants
|
5 Participants
n=5 Participants
|
36 Participants
n=43 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=38 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=43 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=38 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=43 Participants
|
|
Sex/Gender, Customized
Male
|
8 Participants
n=35 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
1 Participants
n=5 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
9 Participants
n=40 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
|
Sex/Gender, Customized
Female
|
26 Participants
n=35 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
4 Participants
n=5 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
30 Participants
n=40 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
|
Sex/Gender, Customized
Non-binary/ Queer
|
1 Participants
n=35 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
0 Participants
n=5 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
1 Participants
n=40 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=35 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
0 Participants
n=5 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
7 Participants
n=40 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=35 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
5 Participants
n=5 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
33 Participants
n=40 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
0 Participants
n=5 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
0 Participants
n=40 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=35 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
0 Participants
n=5 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
0 Participants
n=40 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=35 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
0 Participants
n=5 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
2 Participants
n=40 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=35 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
0 Participants
n=5 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
1 Participants
n=40 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=35 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
0 Participants
n=5 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
1 Participants
n=40 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
|
Race (NIH/OMB)
White
|
25 Participants
n=35 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
4 Participants
n=5 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
29 Participants
n=40 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=35 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
0 Participants
n=5 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
2 Participants
n=40 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=35 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
1 Participants
n=5 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
5 Participants
n=40 Participants • 3 participants were recruited, completed the consenting process (where we collect age data), and were randomized, but did not complete the baseline visit where the rest of our demographic information is collected.
|
|
Region of Enrollment
United States
|
38 participants
n=38 Participants
|
5 participants
n=5 Participants
|
43 participants
n=43 Participants
|
PRIMARY outcome
Timeframe: At Baseline phone visitPopulation: 3 participants did not complete baseline or follow up visits. These 3 individuals completed a few demographic questions and were retained as we intended to treat them in the 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 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.
Outcome measures
| Measure |
BritePath
n=35 Participants
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.
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=5 Participants
Participants in the TAU group will not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Depression Severity
|
12.9 score on a scale
Standard Deviation 4.8
|
9.2 score on a scale
Standard Deviation 5.8
|
PRIMARY outcome
Timeframe: At 4 week follow up after BaselinePopulation: Of the 38 participants assigned to BRITEPath, 32 completed the PHQ-9 at the 4 week follow-up timepoint. Of the 5 participants assigned to TAU, 4 completed the PHQ-9 at the 4 week follow-up timepoint. 3 individuals randomized to BRITEPath completed a few demographic questions and were retained as we intended to treat them in the 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 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.
Outcome measures
| Measure |
BritePath
n=32 Participants
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.
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=4 Participants
Participants in the TAU group will not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Depression Severity
|
10.9 score on a scale
Standard Deviation 6
|
5.5 score on a scale
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: At 12 week follow up after BaselinePopulation: Of the 38 participants assigned to BRITEPath, 32 completed the PHQ-9 at the 12 week follow-up timepoint. Of the 5 participants assigned to TAU, 4 completed the PHQ-9 at the 12 week follow-up timepoint. 3 individuals randomized to BRITEPath completed a few demographic questions and were retained as we intended to treat them in the 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 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.
Outcome measures
| Measure |
BritePath
n=32 Participants
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.
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=4 Participants
Participants in the TAU group will not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Depression Severity
|
10.4 score on a scale
Standard Deviation 5.4
|
9.5 score on a scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: At Baseline phone visitPopulation: Of the 38 participants in BRITEPath intervention, only 35 completed CSSRS. All 5 from TAU completed CSSRS. 3 individuals randomized to BRITEPath completed a few demographic questions and were retained as we intended to treat them in the sample.
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.
Outcome measures
| Measure |
BritePath
n=35 Participants
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.
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=5 Participants
Participants in the TAU group will not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Suicidal Ideation and Behavior
PHQ-9 Question 9 (ideation)
|
1.1 score on a scale
Standard Deviation 1
|
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
|
|
Suicidal Ideation and Behavior
C-SSRS Category 7: Aborted Attempt
|
0.1 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)
|
0.1 score on a scale
Standard Deviation 0.3
|
0 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At 4 week follow up after BaselinePopulation: Of the 38 participants assigned to BRITEPath, 32 completed the C-SSRS at the 4 week follow-up timepoint. Of the 5 participants assigned to TAU, 4 completed the C-SSRS at the 4 week follow-up timepoint. 3 individuals randomized to BRITEPath completed a few demographic questions and were retained as we intended to treat them in the sample.
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.
Outcome measures
| Measure |
BritePath
n=32 Participants
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.
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=4 Participants
Participants in the TAU group will not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Suicidal Ideation and Behavior
C-SSRS Category 8: Interrupted Attempts
|
0 score on a scale
Standard Deviation 0.2
|
0 score on a scale
Standard Deviation 0
|
|
Suicidal Ideation and Behavior
C-SSRS Category 9: Actual Attempts (non-lethal)
|
0.1 score on a scale
Standard Deviation 0.2
|
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
|
|
Suicidal Ideation and Behavior
PHQ-9 Question 9 (ideation)
|
0.9 score on a scale
Standard Deviation 1
|
0 score on a scale
Standard Deviation 0
|
|
Suicidal Ideation and Behavior
C-SSRS Category 7: Aborted Attempts
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: At 12 week follow up after BaselinePopulation: Of the 38 participants assigned to BRITEPath, 32 completed the C-SSRS at the 12 week follow-up timepoint. Of the 5 participants assigned to TAU, 4 completed the C-SSRS at the 12 week follow-up timepoint. 3 individuals randomized to BRITEPath completed a few demographic questions and were retained as we intended to treat them in the sample.
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.
Outcome measures
| Measure |
BritePath
n=32 Participants
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.
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=4 Participants
Participants in the TAU group will not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Suicidal Ideation and Behavior
PHQ-9 Question 9 (ideation)
|
0.6 score on a scale
Standard Deviation 0.8
|
0 score on a scale
Standard Deviation 0
|
|
Suicidal Ideation and Behavior
C-SSRS Category 7: Aborted Attempts
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Suicidal Ideation and Behavior
C-SSRS Category 8: Interrupted Attempts
|
0.1 score on a scale
Standard Deviation 0.2
|
0 score on a scale
Standard Deviation 0
|
|
Suicidal Ideation and Behavior
C-SSRS Category 9: Actual Attempts (non-lethal)
|
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 Baseline phone visitPopulation: Of the 38 participants assigned to BRITEPath, 28 completed the PedsQOL questionnaire at the baseline timepoint. 3 individuals randomized to BRITEPath completed a few demographic questions and were retained as we intended to treat them in the sample.
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.
Outcome measures
| Measure |
BritePath
n=28 Participants
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.
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=5 Participants
Participants in the TAU group will not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Quality of Life and Social/Emotional Functioning
|
63.1 score on a scale
Standard Deviation 12.2
|
70.9 score on a scale
Standard Deviation 18.4
|
PRIMARY outcome
Timeframe: At 4 week follow up after BaselinePopulation: Of the 38 participants assigned to BRITEPath, 25 completed the PedsQOL questionnaire at the 4 week follow-up timepoint. Of the 5 participants assigned to TAU, 4 completed the PedsQOL questionnaire at the 4 week follow-up timepoint. 3 individuals randomized to BRITEPath completed a few demographic questions and were retained as we intended to treat them in the sample.
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.
Outcome measures
| Measure |
BritePath
n=25 Participants
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.
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=4 Participants
Participants in the TAU group will not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Quality of Life and Social/Emotional Functioning
|
71 score on a scale
Standard Deviation 11.8
|
64.8 score on a scale
Standard Deviation 12
|
PRIMARY outcome
Timeframe: At 12 week follow up after BaselinePopulation: Of the 38 participants assigned to BRITEPath, 25 completed the PedsQOL questionnaire at the 12 week follow-up timepoint. Of the 5 participants assigned to TAU, 4 completed the PedsQOL questionnaire at the 12 week follow-up timepoint. 3 individuals randomized to BRITEPath completed a few demographic questions and were retained as we intended to treat them in the sample.
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.
Outcome measures
| Measure |
BritePath
n=25 Participants
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.
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=4 Participants
Participants in the TAU group will not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Quality of Life and Social/Emotional Functioning
|
72.6 score on a scale
Standard Deviation 11.5
|
65.5 score on a scale
Standard Deviation 13
|
SECONDARY outcome
Timeframe: Up to 12 week follow-upPopulation: Only 35 of the 38 participants who engaged with the BRITEPath intervention completed baseline and follow up data collection. Inconsistency in analyses related to only 35 of 38 participants engaging in the BRITEPath intervention is due to the initial 3 who did not COMPLETE baseline data, but completed a couple demographic questions so they were retained as we intended to treat them.
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.
Outcome measures
| Measure |
BritePath
n=38 Participants
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.
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 not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Application Utilization
Second distress level · Completed
|
17 Participants
|
—
|
|
Application Utilization
Soothe guided meditation · Did not complete
|
32 Participants
|
—
|
|
Application Utilization
First distress level · Completed
|
24 Participants
|
—
|
|
Application Utilization
First distress level · Did not complete
|
14 Participants
|
—
|
|
Application Utilization
Second distress level · Did not complete
|
21 Participants
|
—
|
|
Application Utilization
Learn to savor · Completed
|
2 Participants
|
—
|
|
Application Utilization
Learn to savor · Did not complete
|
36 Participants
|
—
|
|
Application Utilization
Reaching out to contacts · Completed
|
9 Participants
|
—
|
|
Application Utilization
Reaching out to contacts · Did not complete
|
29 Participants
|
—
|
|
Application Utilization
Soothe breathe · Completed
|
8 Participants
|
—
|
|
Application Utilization
Soothe breathe · Did not complete
|
30 Participants
|
—
|
|
Application Utilization
Soothe guided meditation · Completed
|
6 Participants
|
—
|
|
Application Utilization
Crisis survival strategies · Completed
|
9 Participants
|
—
|
|
Application Utilization
Crisis survival strategies · Did not complete
|
29 Participants
|
—
|
|
Application Utilization
Distract with happy thoughts · Completed
|
8 Participants
|
—
|
|
Application Utilization
Distract with happy thoughts · Did not complete
|
30 Participants
|
—
|
|
Application Utilization
Distract exercise · Completed
|
4 Participants
|
—
|
|
Application Utilization
Distract exercise · Did not complete
|
34 Participants
|
—
|
|
Application Utilization
Savor · Completed
|
5 Participants
|
—
|
|
Application Utilization
Savor · Did not complete
|
33 Participants
|
—
|
|
Application Utilization
Soothe activities to help you sleep · Completed
|
3 Participants
|
—
|
|
Application Utilization
Soothe activities to help you sleep · Did not complete
|
35 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 12 week follow-upPopulation: Only 35 of the 38 participants who engaged with the BRITEPath intervention completed baseline and follow up data collection. Inconsistency in analyses related to only 35 of 38 participants engaging in the BRITEPath intervention is due to the initial 3 who did not COMPLETE baseline data, but completed a couple demographic questions so they were retained as we intended to treat them.
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.
Outcome measures
| Measure |
BritePath
n=38 Participants
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.
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 not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Application Utilization
Step 2.2 · Completed
|
34 Participants
|
—
|
|
Application Utilization
Step 2.2 · Did not complete
|
4 Participants
|
—
|
|
Application Utilization
Step 2.3 · Did not complete
|
4 Participants
|
—
|
|
Application Utilization
Step 5 · Did not complete
|
23 Participants
|
—
|
|
Application Utilization
Step 1 · Completed
|
28 Participants
|
—
|
|
Application Utilization
Step 1 · Did not complete
|
10 Participants
|
—
|
|
Application Utilization
Step 1.2 · Completed
|
28 Participants
|
—
|
|
Application Utilization
Step 1.2 · Did not complete
|
10 Participants
|
—
|
|
Application Utilization
Step 1.3 · Completed
|
34 Participants
|
—
|
|
Application Utilization
Step 1.3 · Did not complete
|
4 Participants
|
—
|
|
Application Utilization
Step 2 · Completed
|
38 Participants
|
—
|
|
Application Utilization
Step 2 · Did not complete
|
0 Participants
|
—
|
|
Application Utilization
Step 2.1 · Completed
|
34 Participants
|
—
|
|
Application Utilization
Step 2.1 · Did not complete
|
4 Participants
|
—
|
|
Application Utilization
Step 2.3 · Completed
|
34 Participants
|
—
|
|
Application Utilization
Step 2.4 · Completed
|
34 Participants
|
—
|
|
Application Utilization
Step 2.4 · Did not complete
|
4 Participants
|
—
|
|
Application Utilization
Step 2.5 · Completed
|
34 Participants
|
—
|
|
Application Utilization
Step 2.5 · Did not complete
|
4 Participants
|
—
|
|
Application Utilization
Step 3 · Completed
|
33 Participants
|
—
|
|
Application Utilization
Step 3 · Did not complete
|
5 Participants
|
—
|
|
Application Utilization
Step 3.2 · Completed
|
32 Participants
|
—
|
|
Application Utilization
Step 3.2 · Did not complete
|
6 Participants
|
—
|
|
Application Utilization
Step 4 · Completed
|
38 Participants
|
—
|
|
Application Utilization
Step 4 · Did not complete
|
0 Participants
|
—
|
|
Application Utilization
Step 4.1 · Completed
|
31 Participants
|
—
|
|
Application Utilization
Step 4.1 · Did not complete
|
7 Participants
|
—
|
|
Application Utilization
Step 5 · Completed
|
15 Participants
|
—
|
SECONDARY outcome
Timeframe: At Baseline phone visitPopulation: 33 of 38 participants in BRITEPath intervention and 4 of the 5 TAU participants answered CASA questions. 3 individuals randomized to BRITEPath completed a few demographic questions and were retained as we intended to treat them in the sample.
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.
Outcome measures
| Measure |
BritePath
n=33 Participants
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.
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=4 Participants
Participants in the TAU group will not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at Baseline
Use outpatient services
|
32 Participants
|
4 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at Baseline
Use school services
|
18 Participants
|
4 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at Baseline
Use ER services
|
12 Participants
|
0 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at Baseline
Use legal services
|
0 Participants
|
0 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at Baseline
Use inpatient services
|
8 Participants
|
0 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at Baseline
Use medications
|
31 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At 4 week follow up after BaselinePopulation: 32 of 38 participants in the BRITEPath intervention and 4 of the 5 participants in the Treatment As Usual arm of the study responded to CASA questions. 3 individuals randomized to BRITEPath completed a few demographic questions and were retained as we intended to treat them in the sample.
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.
Outcome measures
| Measure |
BritePath
n=32 Participants
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.
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=4 Participants
Participants in the TAU group will not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow Up
Use outpatient services
|
31 Participants
|
4 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow Up
Use school services
|
19 Participants
|
4 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow Up
Use ER services
|
12 Participants
|
0 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow Up
Use legal services
|
0 Participants
|
0 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow Up
Use inpatient services
|
8 Participants
|
0 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow Up
Use medications
|
31 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At 12 week follow up after BaselinePopulation: 32 of 38 BRITEPath intervention participants and 4 of 5 Treatment As Usual participants completed CASA questions. 3 individuals randomized to BRITEPath completed a few demographic questions and were retained as we intended to treat them in the sample.
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.
Outcome measures
| Measure |
BritePath
n=32 Participants
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.
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=4 Participants
Participants in the TAU group will not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow Up
Use outpatient services
|
29 Participants
|
2 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow Up
Use school services
|
4 Participants
|
0 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow Up
Use ER services
|
0 Participants
|
0 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow Up
Use legal services
|
0 Participants
|
0 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow Up
Use inpatient services
|
1 Participants
|
0 Participants
|
|
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow Up
Use medications
|
26 Participants
|
2 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: Out of the 38 participants randomized to receive the BRITE App, only 26 completed the exit interview. 3 individuals randomized to BRITEPath completed a few demographic questions and were retained as we intended to treat them in the sample.
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.
Outcome measures
| Measure |
BritePath
n=26 Participants
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.
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 not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Usability and Satisfaction
If a friend were in need of mental health care, would you recommend BRITEPath? · No, I don't think so
|
3 Participants
|
—
|
|
Usability and Satisfaction
If a friend were in need of mental health care, would you recommend BRITEPath? · Yes, I think so
|
14 Participants
|
—
|
|
Usability and Satisfaction
If a friend were in need of mental health care, would you recommend BRITEPath? · Yes, definitely
|
9 Participants
|
—
|
|
Usability and Satisfaction
If a friend were in need of mental health care, would you recommend BRITEPath? · Dissatisfied
|
0 Participants
|
—
|
|
Usability and Satisfaction
If a friend were in need of mental health care, would you recommend BRITEPath? · Satisfied
|
0 Participants
|
—
|
|
Usability and Satisfaction
If a friend were in need of mental health care, would you recommend BRITEPath? · Very Satisfied
|
0 Participants
|
—
|
|
Usability and Satisfaction
If a friend were in need of mental health care, would you recommend BRITEPath? · Really didn't help
|
0 Participants
|
—
|
|
Usability and Satisfaction
If a friend were in need of mental health care, would you recommend BRITEPath? · Yes, somewhat
|
0 Participants
|
—
|
|
Usability and Satisfaction
If a friend were in need of mental health care, would you recommend BRITEPath? · Yes, a great deal
|
0 Participants
|
—
|
|
Usability and Satisfaction
How satisfied were you with the amount of help you received? · No, I don't think so
|
0 Participants
|
—
|
|
Usability and Satisfaction
How satisfied were you with the amount of help you received? · Yes, I think so
|
0 Participants
|
—
|
|
Usability and Satisfaction
How satisfied were you with the amount of help you received? · Yes, definitely
|
0 Participants
|
—
|
|
Usability and Satisfaction
How satisfied were you with the amount of help you received? · Dissatisfied
|
1 Participants
|
—
|
|
Usability and Satisfaction
How satisfied were you with the amount of help you received? · Satisfied
|
18 Participants
|
—
|
|
Usability and Satisfaction
How satisfied were you with the amount of help you received? · Very Satisfied
|
7 Participants
|
—
|
|
Usability and Satisfaction
How satisfied were you with the amount of help you received? · Really didn't help
|
0 Participants
|
—
|
|
Usability and Satisfaction
How satisfied were you with the amount of help you received? · Yes, somewhat
|
0 Participants
|
—
|
|
Usability and Satisfaction
How satisfied were you with the amount of help you received? · Yes, a great deal
|
0 Participants
|
—
|
|
Usability and Satisfaction
Have the services you received help you to deal more effectively with your problem? · No, I don't think so
|
0 Participants
|
—
|
|
Usability and Satisfaction
Have the services you received help you to deal more effectively with your problem? · Yes, I think so
|
0 Participants
|
—
|
|
Usability and Satisfaction
Have the services you received help you to deal more effectively with your problem? · Yes, definitely
|
0 Participants
|
—
|
|
Usability and Satisfaction
Have the services you received help you to deal more effectively with your problem? · Dissatisfied
|
0 Participants
|
—
|
|
Usability and Satisfaction
Have the services you received help you to deal more effectively with your problem? · Satisfied
|
0 Participants
|
—
|
|
Usability and Satisfaction
Have the services you received help you to deal more effectively with your problem? · Very Satisfied
|
0 Participants
|
—
|
|
Usability and Satisfaction
Have the services you received help you to deal more effectively with your problem? · Really didn't help
|
2 Participants
|
—
|
|
Usability and Satisfaction
Have the services you received help you to deal more effectively with your problem? · Yes, somewhat
|
20 Participants
|
—
|
|
Usability and Satisfaction
Have the services you received help you to deal more effectively with your problem? · Yes, a great deal
|
4 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: Out of the 38 participants randomized to receive the BRITE App, 26 completed the exit interview. 3 individuals randomized to BRITEPath completed a few demographic questions and were retained as we intended to treat them in the sample.
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=26 Participants
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.
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 not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Usability and Satisfaction
Overall, I am satisfied with how easy it is to use the BRITE app
|
5.7 score on a scale
Standard Deviation 1.4
|
—
|
|
Usability and Satisfaction
The information provided with the BRITE app was clear
|
6.2 score on a scale
Standard Deviation 1.2
|
—
|
|
Usability and Satisfaction
The information provided in the BRITE app such as notifications to rate my mood was clear
|
6.1 score on a scale
Standard Deviation 1
|
—
|
|
Usability and Satisfaction
The information provided during the onboarding with my therapist was clear
|
6.5 score on a scale
Standard Deviation 0.8
|
—
|
|
Usability and Satisfaction
I liked interacting with the BRITE app program
|
5.8 score on a scale
Standard Deviation 1
|
—
|
|
Usability and Satisfaction
I needed to learn a lot of things before I could get going with the BRITE app
|
1.8 score on a scale
Standard Deviation 1.2
|
—
|
SECONDARY outcome
Timeframe: At 12 week follow up after BaselinePopulation: 32 of 38 BRITEPath intervention participants interacted with the app. 3 individuals randomized to BRITEPath completed a few demographic questions and were retained as we intended to treat them in the sample. The below measures are based on estimates from staff and not on empirical data at the individual level.
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.
Outcome measures
| Measure |
BritePath
n=32 Participants
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.
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 not receive the Brite emotion regulation/safety planning app. If participants in the TAU group are determined to be at risk for suicidal ideation or behavior, usual care of a paper-based safety plan will be utilized.
|
|---|---|---|
|
Cost Estimate for Implementation of BRITEPath Intervention
|
457.43 dollars per participant
Interval 214.1 to 597.05
|
—
|
Adverse Events
BritePath
Treatment As Usual (TAU)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place