BRITEPath, Component 3 of iCHART (Integrated Care to Help At-Risk Teens)

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT04000399
• Collaborator: Kaiser Foundation Research Institute (Other), National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 43
• Locations: 6
• Arm: 1
• Actual Duration (Months): 18.2
• Patients Per Site: 7.2
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

BRITEPath (BP) aims to support co-located mental health clinicians in the development of a high quality, effective, and personalized safety plan for referred patients who screen positive for depression and/or suicidal ideation.

BRITEPath utilizes BRITE, a safety planning and emotion regulation app that is loaded on the patient's smart phone and has previously been shown to be well accepted and to reduce suicide attempts compared to usual care in psychiatric inpatients (HR = 0.49). To support mental health clinicians in the development of effective safety plans, study investigators will develop Guide2Brite (G2B), which provides step-by-step instructions for the mental health clinician on how to populate BRITE onto the patient's smartphone and BRITEBoard, a clinician dashboard that tracks patient symptoms, app use, and rating on helpfulness of different interventions assessed through BRITE.

Condition or Disease	Intervention/Treatment	Phase
Depression; Suicidal Ideation	Behavioral: BRITEPath	N/A

Detailed Description

Delivery of Interventions:

BRITEPath has 3 components:1) BRITE, an emotion regulation and safety planning phone app that is delivered by a co-located mental health (MH) clinician to adolescents at the time of their first therapy appointment; 2) Guide2Brite, which will guide the co-located MH clinician in working with the adolescent to population content onto BRITE; and 3) BRITEBoard, which is a clinician dashboard delivered to the MH clinician and PCP.

Assignment of Interventions:

This study utilized an open trial design. A stepped wedge design was originally proposed and efforts were made to adhere to this study design, however after a year of low recruitment and resultant recruitment sites pulling out the of the study, the overall study design was changed to an open trial. Additional recruitment sites were onboarded to the study and provided with the intervention arm in order to obtain feasibility data on the intervention components of the study. As a result of the change, there are some TAU participants included in this study. For reference a stepped wedge design involves the sequential random rollout of an intervention over two time periods. Following a baseline period in which no clusters (=practices) are exposed to the intervention, the crossover is typically in one direction, from control to intervention and continues until both of the clusters have crossed-over to receive the intervention, with observations taken from each cluster and at each time period.

Study investigators will pilot BRITEPath in community pediatric and mental health practices using a stepped wedge design (n =50 adolescents).

Hypothesis: The use of BRITEPath will decrease depressive symptoms, distress, and suicidality (any self-injurious ideation, urges, or behavior) as well as improve overall functioning compared to TAU.

Of note: Study investigators initially intended to do a cost analysis as a secondary outcome measure, but it was later decided that the analysis will not be done in this pilot phase of testing and will instead be completed during the Phase 2 RCT.

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Ultimately, this study design was an open trial after unsuccessful attempts to maintain initial recruitment sites in the study. This study initially attempted to use a stepped wedge design, which involves the sequential random rollout of an intervention over 2 time periods. Following a baseline period in which no clusters (= practices) are exposed to the intervention, the crossover is typically in one direction, from control to intervention and continues until both of the clusters have crossed-over to receive the intervention, with observations taken from each cluster and at each time period.Ultimately, this study design was an open trial after unsuccessful attempts to maintain initial recruitment sites in the study. This study initially attempted to use a stepped wedge design, which involves the sequential random rollout of an intervention over 2 time periods. Following a baseline period in which no clusters (= practices) are exposed to the intervention, the crossover is typically in one direction, from control to intervention and continues until both of the clusters have crossed-over to receive the intervention, with observations taken from each cluster and at each time period.
• Masking: None (Open Label)
• Masking Description: Outcomes assessors will be masked to the intervention condition at follow-up assessment timepoints. See notes on pre-assignment details in participant flow related to study model single arm vs. multi arm.
• Primary Purpose: Health Services Research
• Official Title: BRITEPath, Component 3 of iCHART (Integrated Care to Help At-Risk Teens)
• Actual Study Start Date: Aug 6, 2019
• Actual Primary Completion Date: Feb 9, 2021
• Actual Study Completion Date: Feb 9, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: BRITEPath; BRITEPath will guide co-located mental health clinicians in the use of an emotion regulation and safety planning app (BRITE) to be loaded on the phone of depressed and suicidal adolescents in order to improve depression and reduce the likelihood of a suicide attempt.

Outcome Measures

Primary Outcome Measures

1. Depression Severity [At Baseline phone visit]

   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.

2. Depression Severity [At 4 week follow up after Baseline]

   Total scores from the Patient Health Questionnaire (PHQ-9) will be used to assess depression severity, as a primary outcome. The PHQ-9 is 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.

3. Depression Severity [At 12 week follow up after Baseline]

   Total scores from the Patient Health Questionnaire (PHQ-9) will be used to assess depression severity, as a primary outcome. The PHQ-9 is 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.

4. Suicidal Ideation and Behavior [At Baseline phone visit]

   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.

5. Suicidal Ideation and Behavior [At 4 week follow up after Baseline]

   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.

6. Suicidal Ideation and Behavior [At 12 week follow up after Baseline]

   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.

7. Quality of Life and Social/Emotional Functioning [At Baseline phone visit]

   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.

8. Quality of Life and Social/Emotional Functioning [At 4 week follow up after Baseline]

   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.

9. Quality of Life and Social/Emotional Functioning [At 12 week follow up after Baseline]

   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.

Secondary Outcome Measures

1. Application Utilization [Up to 12 week follow-up]

   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.

2. Application Utilization [Up to 12 week follow-up]

   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.

3. Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at Baseline [At Baseline phone visit]

   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.

4. Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow Up [At 4 week follow up after Baseline]

   The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.

5. Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow Up [At 12 week follow up after Baseline]

   The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.

6. Usability and Satisfaction [At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools)]

   Satisfaction to BRITEPath will be assessed through questions developed by investigators to understand experience with the program. Questions investigators have adapted from literature reviews on satisfaction include: "If a friend were in need of mental health care for depression or suicidal thoughts or behaviors, would you recommend BRITEPath to help him/her manage symptoms? 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.

7. Usability and Satisfaction [At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools)]

   Satisfaction 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.

8. Cost Estimate for Implementation of BRITEPath Intervention [At 12 week follow up after Baseline]

   An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 26 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Youth aged 12-26 yo

• Own a device (e.g. smartphone, ipod, tablet) with capability to download BRITE app

• Biological or adoptive parent is willing to provide informed consent for teen to participate

• Youth speaks and understands English

• Positive PHQ score or provider determines youth has depressive symptoms based on clinical interaction and refers youth to the study (in cases when PHQ is not available and study staff will complete the PHQ during the screening) OR Provider can refer if they are unclear if symptoms are depressive and PHQ scoring will be used to determine youth's eligibility. OR Screening Wizard screening questionnaire (which includes the PHQ and depressive symptom questions) indicates depression OR provider/parent have concern that youth/patient has a mood or behavioral problem

• Family agrees to see an (embedded) MH therapist at the practice

PHQ scores:

Score of 8 or higher on PHQ-8 -or- Score of 1 or higher on #9 of PHQ-9 suicidality item

Exclusion Criteria:

Non English speaking No parent willing to provide informed consent No cell phone capability of downloading BRITE app Is currently experiencing mania or psychosis Evidence of an intellectual or developmental disorder (IDD) Life threatening medical condition that requires immediate treatment (included emergent suicidality, homicidality, abuse/neglect, or other mental or physical condition) Other cognitive or medical condition preventing youth from understanding study and/or participating.

Currently receiving MH treatment/currently satisfied with treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwell Hospital	Hyde Park	New York	United States	11040
2	Children's Community Pediatrics (CCP-Moon) of Children's Hospital of Pittsburgh of UPMC	Moon	Pennsylvania	United States	15108
3	STAR-Center	Pittsburgh	Pennsylvania	United States	15213
4	Wesley Family Services	Pittsburgh	Pennsylvania	United States	15221
5	Children's Community Pediatrics (CCP-Wexford) of Children's Hospital of Pittsburgh of UPMC	Wexford	Pennsylvania	United States	15090
6	Seattle Children's Hospital	Seattle	Washington	United States	98105

Sponsors and Collaborators

• University of Pittsburgh
• Kaiser Foundation Research Institute
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Stephanie Stepp, PhD, University of Pittsburgh
• Study Director: David Brent, MD, University of Pittsburgh

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 30, 2020
• Informed Consent Form - Apr 19, 2021

More Information

Publications

None provided.

• Responsible Party: Stephanie Stepp, Associate Professor of Psychiatry and Psychology, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT04000399
• Other Study ID Numbers: Study18120080; P50MH115838-02
• First Posted: Jun 27, 2019
• Last Update Posted: Aug 8, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Suicidal Ideation

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	BritePath	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	38	5
COMPLETED	38	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	BritePath	Treatment As Usual (TAU)	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	38	5	43
Age (Count of Participants)
<=18 years	31 81.6%	5 100%	36 83.7%
Between 18 and 65 years	7 18.4%	0 0%	7 16.3%
>=65 years	0 0%	0 0%	0 0%
Sex/Gender, Customized (Count of Participants)
Male	8 21.1%	1 20%	9 20.9%
Female	26 68.4%	4 80%	30 69.8%
Non-binary/ Queer	1 2.6%	0 0%	1 2.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 18.4%	0 0%	7 16.3%
Not Hispanic or Latino	28 73.7%	5 100%	33 76.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 5.3%	0 0%	2 4.7%
Native Hawaiian or Other Pacific Islander	1 2.6%	0 0%	1 2.3%
Black or African American	1 2.6%	0 0%	1 2.3%
White	25 65.8%	4 80%	29 67.4%
More than one race	2 5.3%	0 0%	2 4.7%
Unknown or Not Reported	4 10.5%	1 20%	5 11.6%
Region of Enrollment (participants) [Number]
United States	38 100%	5 100%	43 100%

Outcome Measures

1. Primary Outcome

Title	Depression Severity
Description	Total scores from the Patient Health Questionnaire (PHQ-9) will be used to assess depression severity, as a primary outcome. The PHQ-9 is 9 items with scoring ranging from 0-27. The higher the score, the more severe the depression symptoms are. A score of 0-4=no depression; 5-9=mild depression; 10-14=moderate depression; 15-19=moderately severe depression; 20-27=severe depression symptoms.
Time Frame	At Baseline phone visit

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BritePath	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	35	5
Mean (Standard Deviation) [score on a scale]	12.9 (4.8)	9.2 (5.8)

2. Primary Outcome

Title	Depression Severity
Description	Total scores from the Patient Health Questionnaire (PHQ-9) will be used to assess depression severity, as a primary outcome. The PHQ-9 is 9 items with scoring ranging from 0-27. The higher the score, the more severe the depression symptoms are. A score of 0-4=no depression; 5-9=mild depression; 10-14=moderate depression; 15-19=moderately severe depression; 20-27=severe depression symptoms.
Time Frame	At 4 week follow up after Baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BritePath	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	32	4
Mean (Standard Deviation) [score on a scale]	10.9 (6)	5.5 (1.3)

3. Primary Outcome

Title	Depression Severity
Description	Total scores from the Patient Health Questionnaire (PHQ-9) will be used to assess depression severity, as a primary outcome. The PHQ-9 is 9 items with scoring ranging from 0-27. The higher the score, the more severe the depression symptoms are. A score of 0-4=no depression; 5-9=mild depression; 10-14=moderate depression; 15-19=moderately severe depression; 20-27=severe depression symptoms.
Time Frame	At 12 week follow up after Baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BritePath	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	32	4
Mean (Standard Deviation) [score on a scale]	10.4 (5.4)	9.5 (1.7)

4. Primary Outcome

Title	Suicidal Ideation and Behavior
Description	Suicidal attempt & ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS) and the Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present and assign a score of 1 if ideation/behavior present. A "yes" answer any time during treatment to question 9 on the PHQ-9 indicates suicidal ideation. A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 7-10) on the C-SSRS. C-SSRS Categories 7-10 are as follows: 7-Aborted Attempt 8-Interrupted Attempt 9-Actual Attempt (non-fatal) 10-Completed Suicide. Any score greater than 0 is important/may indicate need for intervention.
Time Frame	At Baseline phone visit

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BritePath	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	35	5
PHQ-9 Question 9 (ideation)	1.1 (1)	0 (0)
C-SSRS Category 7: Aborted Attempt	0.1 (0.2)	0 (0)
C-SSRS Category 8: Interrupted Attempt	0 (0)	0 (0)
C-SSRS Category 9: Actual Attempt (non-fatal)	0.1 (0.3)	0 (0)
C-SSRS Category 10: Completed Suicide	0 (0)	0 (0)

5. Primary Outcome

Title	Suicidal Ideation and Behavior
Description	Suicidal attempt & ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS) and the Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present and assign a score of 1 if ideation/behavior present. A "yes" answer any time during treatment to question 9 on the PHQ-9 indicates suicidal ideation. A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 7-10) on the C-SSRS. C-SSRS Categories 7-10 are as follows: 7-Aborted Attempt 8-Interrupted Attempt 9-Actual Attempt (non-fatal) 10-Completed Suicide. Any score greater than 0 is important/may indicate need for intervention.
Time Frame	At 4 week follow up after Baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BritePath	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	32	4
PHQ-9 Question 9 (ideation)	0.9 (1)	0 (0)
C-SSRS Category 7: Aborted Attempts	0 (0)	0 (0)
C-SSRS Category 8: Interrupted Attempts	0 (0.2)	0 (0)
C-SSRS Category 9: Actual Attempts (non-lethal)	0.1 (0.2)	0 (0)
C-SSRS Category 10: Completed Suicide	0 (0)	0 (0)

6. Primary Outcome

Title	Suicidal Ideation and Behavior
Description	Suicidal attempt & ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS) and the Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present and assign a score of 1 if ideation/behavior present. A "yes" answer any time during treatment to question 9 on the PHQ-9 indicates suicidal ideation. A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 7-10) on the C-SSRS. C-SSRS Categories 7-10 are as follows: 7-Aborted Attempt 8-Interrupted Attempt 9-Actual Attempt (non-fatal) 10-Completed Suicide. Any score greater than 0 is important/may indicate need for intervention.
Time Frame	At 12 week follow up after Baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BritePath	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	32	4
PHQ-9 Question 9 (ideation)	0.6 (0.8)	0 (0)
C-SSRS Category 7: Aborted Attempts	0 (0)	0 (0)
C-SSRS Category 8: Interrupted Attempts	0.1 (0.2)	0 (0)
C-SSRS Category 9: Actual Attempts (non-lethal)	0 (0)	0 (0)
C-SSRS Category 10: Completed Suicide	0 (0)	0 (0)

7. Primary Outcome

Title	Quality of Life and Social/Emotional Functioning
Description	The Pediatric Quality of Life Inventory Version 4.0 (PedsQOL) will be used to assess overall quality of life and functioning, as a primary outcome. The PEDSQOL has 23 items and ranges in score from 0-92. It is broken down into 4 subdomains of physical functioning, emotional functioning, social functioning, and work/school (psychosocial) functioning. The higher the score, the more problems the respondent associates with the prompt/sub domain.
Time Frame	At Baseline phone visit

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BritePath	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	28	5
Mean (Standard Deviation) [score on a scale]	63.1 (12.2)	70.9 (18.4)

8. Primary Outcome

Title	Quality of Life and Social/Emotional Functioning
Description	The Pediatric Quality of Life Inventory Version 4.0 (PedsQOL) will be used to assess overall quality of life and functioning, as a primary outcome. The PEDSQOL has 23 items and ranges in score from 0-92. It is broken down into 4 subdomains of physical functioning, emotional functioning, social functioning, and work/school (psychosocial) functioning. The higher the score, the more problems the respondent associates with the prompt/sub domain.
Time Frame	At 4 week follow up after Baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BritePath	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	25	4
Mean (Standard Deviation) [score on a scale]	71 (11.8)	64.8 (12)

9. Primary Outcome

Title	Quality of Life and Social/Emotional Functioning
Description	The Pediatric Quality of Life Inventory Version 4.0 (PedsQOL) will be used to assess overall quality of life and functioning, as a primary outcome. The PEDSQOL has 23 items and ranges in score from 0-92. It is broken down into 4 subdomains of physical functioning, emotional functioning, social functioning, and work/school (psychosocial) functioning. The higher the score, the more problems the respondent associates with the prompt/sub domain.
Time Frame	At 12 week follow up after Baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BritePath	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	25	4
Mean (Standard Deviation) [score on a scale]	72.6 (11.5)	65.5 (13)

10. Secondary Outcome

Title	Application Utilization
Description	Use of the technical components of the BRITEApp for adolescents and young adults will be monitored throughout Phase 1b. Utilization will be measured by the number of participants who have engaged with the application over time, including rating distress levels in the app and utilizing the following app features: learn to savor, reaching out to contacts, soothe breathe, sooth guided meditation, crisis survival strategies, distract with happy thoughts, distract exercise, savor, and soothe activities to help you sleep.
Time Frame	Up to 12 week follow-up

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BRITEPath
Arm/Group Description	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.
Measure Participants	38
Completed	24 63.2%
Did not complete	14 36.8%
Completed	17 44.7%
Did not complete	21 55.3%
Completed	2 5.3%
Did not complete	36 94.7%
Completed	9 23.7%
Did not complete	29 76.3%
Completed	8 21.1%
Did not complete	30 78.9%
Completed	6 15.8%
Did not complete	32 84.2%
Completed	9 23.7%
Did not complete	29 76.3%
Completed	8 21.1%
Did not complete	30 78.9%
Completed	4 10.5%
Did not complete	34 89.5%
Completed	5 13.2%
Did not complete	33 86.8%
Completed	3 7.9%
Did not complete	35 92.1%

11. Secondary Outcome

Title	Application Utilization
Description	Use of the technical components of Guide2BRITE and the BRITEPortal for physicians will be monitored throughout Phase 1b. Utilization will be measured by the number of providers who have completed the Guide2BRITE onboarding process which includes steps 1, 1.2, 1.3, 2, 2.1, 2.2, 2.3, 2.4, 2.5, 3, 3.2, 4, 4.1, and 5.
Time Frame	Up to 12 week follow-up

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BRITEPath
Arm/Group Description	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.
Measure Participants	38
Completed	28 73.7%
Did not complete	10 26.3%
Completed	28 73.7%
Did not complete	10 26.3%
Completed	34 89.5%
Did not complete	4 10.5%
Completed	38 100%
Did not complete	0 0%
Completed	34 89.5%
Did not complete	4 10.5%
Completed	34 89.5%
Did not complete	4 10.5%
Completed	34 89.5%
Did not complete	4 10.5%
Completed	34 89.5%
Did not complete	4 10.5%
Completed	34 89.5%
Did not complete	4 10.5%
Completed	33 86.8%
Did not complete	5 13.2%
Completed	32 84.2%
Did not complete	6 15.8%
Completed	38 100%
Did not complete	0 0%
Completed	31 81.6%
Did not complete	7 18.4%
Completed	15 39.5%
Did not complete	23 60.5%

12. Secondary Outcome

Title	Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at Baseline
Description	The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
Time Frame	At Baseline phone visit

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BRITEPath	Treatment As Usual
Arm/Group Description	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.	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.
Measure Participants	33	4
Use outpatient services	32 84.2%	4 80%
Use school services	18 47.4%	4 80%
Use ER services	12 31.6%	0 0%
Use legal services	0 0%	0 0%
Use inpatient services	8 21.1%	0 0%
Use medications	31 81.6%	2 40%

13. Secondary Outcome

Title	Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow Up
Description	The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
Time Frame	At 4 week follow up after Baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BritePath	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	32	4
Use outpatient services	31 81.6%	4 80%
Use school services	19 50%	4 80%
Use ER services	12 31.6%	0 0%
Use legal services	0 0%	0 0%
Use inpatient services	8 21.1%	0 0%
Use medications	31 81.6%	2 40%

14. Secondary Outcome

Title	Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow Up
Description	The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
Time Frame	At 12 week follow up after Baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BritePath	Treatment As Usual (TAU)
Arm/Group Description	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.	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.
Measure Participants	32	4
Use outpatient services	29 76.3%	2 40%
Use school services	4 10.5%	0 0%
Use ER services	0 0%	0 0%
Use legal services	0 0%	0 0%
Use inpatient services	1 2.6%	0 0%
Use medications	26 68.4%	2 40%

15. Secondary Outcome

Title	Usability and Satisfaction
Description	Satisfaction to BRITEPath will be assessed through questions developed by investigators to understand experience with the program. Questions investigators have adapted from literature reviews on satisfaction include: "If a friend were in need of mental health care for depression or suicidal thoughts or behaviors, would you recommend BRITEPath to help him/her manage symptoms? with answer options of: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely How satisfied are you with the amount of help you received? with answer options of: Dissatisfied; Satisfied; Very Satisfied Have the services you received helped you to deal more effectively with your problems? with answer options of: Really didn't help; Yes, somewhat; Yes, a great deal.
Time Frame	At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BRITEPath
Arm/Group Description	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.
Measure Participants	26
No, I don't think so	3 7.9%
Yes, I think so	14 36.8%
Yes, definitely	9 23.7%
Dissatisfied	0 0%
Satisfied	0 0%
Very Satisfied	0 0%
Really didn't help	0 0%
Yes, somewhat	0 0%
Yes, a great deal	0 0%
No, I don't think so	0 0%
Yes, I think so	0 0%
Yes, definitely	0 0%
Dissatisfied	1 2.6%
Satisfied	18 47.4%
Very Satisfied	7 18.4%
Really didn't help	0 0%
Yes, somewhat	0 0%
Yes, a great deal	0 0%
No, I don't think so	0 0%
Yes, I think so	0 0%
Yes, definitely	0 0%
Dissatisfied	0 0%
Satisfied	0 0%
Very Satisfied	0 0%
Really didn't help	2 5.3%
Yes, somewhat	20 52.6%
Yes, a great deal	4 10.5%

16. Secondary Outcome

Title	Usability and Satisfaction
Description	Satisfaction with the technical components of interventions will be assessed through the certain questions from the Post System Satisfaction and Usability Questionnaire (PSSUQ). The PSSUQ is 19 items with response options ranging from 1 to 7 where 1=strongly disagree and 7=strongly agree. The PSSUQ has sub-scores derived from subsets of the questions which reflect system usefulness, information quality, and interface quality. Questions from sub-domains were chosen to tailor the questioning to this particular intervention.
Time Frame	At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BRITEPath
Arm/Group Description	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.
Measure Participants	26
Overall, I am satisfied with how easy it is to use the BRITE app	5.7 (1.4)
The information provided with the BRITE app was clear	6.2 (1.2)
The information provided in the BRITE app such as notifications to rate my mood was clear	6.1 (1)
The information provided during the onboarding with my therapist was clear	6.5 (0.8)
I liked interacting with the BRITE app program	5.8 (1)
I needed to learn a lot of things before I could get going with the BRITE app	1.8 (1.2)

17. Secondary Outcome

Title	Cost Estimate for Implementation of BRITEPath Intervention
Description	An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated. Outcome measure data below highlights the estimated cost of the intervention BRITEPath Intervention per participant, measures were based on estimates from staff and not on empirical data at the individual level.
Time Frame	At 12 week follow up after Baseline

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BRITEPath Intervention
Arm/Group Description	Participants in the BritePath intervention group receive and emotion regulation/safety planning app.
Measure Participants	32
Mean (Full Range) [dollars per participant]	457.43

Adverse Events

Time Frame	Participants were assessed for adverse events at each timepoint (baseline, 4 week follow-up, 12 week follow-up).
Arm/Group Title	BritePath		Treatment As Usual (TAU)
Arm/Group Description	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.		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.
All Cause Mortality
	BritePath		Treatment As Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/5 (0%)
Serious Adverse Events
	BritePath		Treatment As Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	BritePath		Treatment As Usual (TAU)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/5 (0%)

Limitations/Caveats

The small sample size of this pilot study was selected for feasibility testing, not for hypothesis testing; thus, inferential tests were underpowered and conducted for exploratory purposes. It lacked a full control group we originally intended to collect, which limits our ability to know whether treatment improvements were due to BRITEPath or to standard care. The impact of treatment on individuals who dropped out of treatment and on those lost during follow-up is unknown.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.