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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04000399
Enrollment
43
Registered
2019-06-27
Start date
2019-08-06
Completion date
2021-02-09
Last updated
2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Suicidal Ideation

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.

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.

Interventions

BEHAVIORALBRITEPath

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.

Sponsors

Kaiser Foundation Research Institute
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

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.

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.

Eligibility

Sex/Gender
ALL
Age
12 Years to 26 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Depression SeverityAt Baseline phone visitTotal 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.
Suicidal Ideation and BehaviorAt Baseline phone visitSuicidal 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.
Quality of Life and Social/Emotional FunctioningAt Baseline phone visitThe 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

MeasureTime frameDescription
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow UpAt 12 week follow up after BaselineThe 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.
Application UtilizationUp to 12 week follow-upUse 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.
Cost Estimate for Implementation of BRITEPath InterventionAt 12 week follow up after BaselineAn 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.
Usability and SatisfactionAt 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.
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at BaselineAt Baseline phone visitThe 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.
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow UpAt 4 week follow up after BaselineThe 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.

Countries

United States

Participant flow

Pre-assignment details

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.

Participants by arm

ArmCount
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.
38
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.
5
Total43

Baseline characteristics

CharacteristicTotalBritePathTreatment As Usual (TAU)
Age, Categorical
<=18 years
36 Participants31 Participants5 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
7 Participants7 Participants0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants7 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
33 Participants28 Participants5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants0 Participants
Race (NIH/OMB)
More than one race
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants4 Participants1 Participants
Race (NIH/OMB)
White
29 Participants25 Participants4 Participants
Region of Enrollment
United States
43 participants38 participants5 participants
Sex/Gender, Customized
Female
30 Participants26 Participants4 Participants
Sex/Gender, Customized
Male
9 Participants8 Participants1 Participants
Sex/Gender, Customized
Non-binary/ Queer
1 Participants1 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 350 / 5
other
Total, other adverse events
0 / 350 / 5
serious
Total, serious adverse events
0 / 350 / 5

Outcome results

Primary

Depression Severity

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

Population: 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.

ArmMeasureValue (MEAN)Dispersion
BritePathDepression Severity12.9 score on a scaleStandard Deviation 4.8
Treatment As Usual (TAU)Depression Severity9.2 score on a scaleStandard Deviation 5.8
Primary

Depression Severity

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

Population: 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.

ArmMeasureValue (MEAN)Dispersion
BritePathDepression Severity10.9 score on a scaleStandard Deviation 6
Treatment As Usual (TAU)Depression Severity5.5 score on a scaleStandard Deviation 1.3
Primary

Depression Severity

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

Population: 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.

ArmMeasureValue (MEAN)Dispersion
BritePathDepression Severity10.4 score on a scaleStandard Deviation 5.4
Treatment As Usual (TAU)Depression Severity9.5 score on a scaleStandard Deviation 1.7
Primary

Quality of Life and Social/Emotional Functioning

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

Time frame: At 12 week follow up after Baseline

Population: 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.

ArmMeasureValue (MEAN)Dispersion
BritePathQuality of Life and Social/Emotional Functioning72.6 score on a scaleStandard Deviation 11.5
Treatment As Usual (TAU)Quality of Life and Social/Emotional Functioning65.5 score on a scaleStandard Deviation 13
Primary

Quality of Life and Social/Emotional Functioning

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

Time frame: At Baseline phone visit

Population: 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.

ArmMeasureValue (MEAN)Dispersion
BritePathQuality of Life and Social/Emotional Functioning63.1 score on a scaleStandard Deviation 12.2
Treatment As Usual (TAU)Quality of Life and Social/Emotional Functioning70.9 score on a scaleStandard Deviation 18.4
Primary

Quality of Life and Social/Emotional Functioning

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

Time frame: At 4 week follow up after Baseline

Population: 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.

ArmMeasureValue (MEAN)Dispersion
BritePathQuality of Life and Social/Emotional Functioning71 score on a scaleStandard Deviation 11.8
Treatment As Usual (TAU)Quality of Life and Social/Emotional Functioning64.8 score on a scaleStandard Deviation 12
Primary

Suicidal Ideation and Behavior

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

Time frame: At 12 week follow up after Baseline

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
BritePathSuicidal Ideation and BehaviorC-SSRS Category 7: Aborted Attempts0 score on a scaleStandard Deviation 0
BritePathSuicidal Ideation and BehaviorC-SSRS Category 9: Actual Attempts (non-lethal)0 score on a scaleStandard Deviation 0
BritePathSuicidal Ideation and BehaviorC-SSRS Category 8: Interrupted Attempts0.1 score on a scaleStandard Deviation 0.2
BritePathSuicidal Ideation and BehaviorC-SSRS Category 10: Completed Suicide0 score on a scaleStandard Deviation 0
BritePathSuicidal Ideation and BehaviorPHQ-9 Question 9 (ideation)0.6 score on a scaleStandard Deviation 0.8
Treatment As Usual (TAU)Suicidal Ideation and BehaviorC-SSRS Category 10: Completed Suicide0 score on a scaleStandard Deviation 0
Treatment As Usual (TAU)Suicidal Ideation and BehaviorPHQ-9 Question 9 (ideation)0 score on a scaleStandard Deviation 0
Treatment As Usual (TAU)Suicidal Ideation and BehaviorC-SSRS Category 7: Aborted Attempts0 score on a scaleStandard Deviation 0
Treatment As Usual (TAU)Suicidal Ideation and BehaviorC-SSRS Category 8: Interrupted Attempts0 score on a scaleStandard Deviation 0
Treatment As Usual (TAU)Suicidal Ideation and BehaviorC-SSRS Category 9: Actual Attempts (non-lethal)0 score on a scaleStandard Deviation 0
Primary

Suicidal Ideation and Behavior

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

Time frame: At 4 week follow up after Baseline

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
BritePathSuicidal Ideation and BehaviorC-SSRS Category 7: Aborted Attempts0 score on a scaleStandard Deviation 0
BritePathSuicidal Ideation and BehaviorC-SSRS Category 9: Actual Attempts (non-lethal)0.1 score on a scaleStandard Deviation 0.2
BritePathSuicidal Ideation and BehaviorC-SSRS Category 8: Interrupted Attempts0 score on a scaleStandard Deviation 0.2
BritePathSuicidal Ideation and BehaviorC-SSRS Category 10: Completed Suicide0 score on a scaleStandard Deviation 0
BritePathSuicidal Ideation and BehaviorPHQ-9 Question 9 (ideation)0.9 score on a scaleStandard Deviation 1
Treatment As Usual (TAU)Suicidal Ideation and BehaviorC-SSRS Category 10: Completed Suicide0 score on a scaleStandard Deviation 0
Treatment As Usual (TAU)Suicidal Ideation and BehaviorPHQ-9 Question 9 (ideation)0 score on a scaleStandard Deviation 0
Treatment As Usual (TAU)Suicidal Ideation and BehaviorC-SSRS Category 7: Aborted Attempts0 score on a scaleStandard Deviation 0
Treatment As Usual (TAU)Suicidal Ideation and BehaviorC-SSRS Category 8: Interrupted Attempts0 score on a scaleStandard Deviation 0
Treatment As Usual (TAU)Suicidal Ideation and BehaviorC-SSRS Category 9: Actual Attempts (non-lethal)0 score on a scaleStandard Deviation 0
Primary

Suicidal Ideation and Behavior

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

Time frame: At Baseline phone visit

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
BritePathSuicidal Ideation and BehaviorC-SSRS Category 7: Aborted Attempt0.1 score on a scaleStandard Deviation 0.2
BritePathSuicidal Ideation and BehaviorC-SSRS Category 9: Actual Attempt (non-fatal)0.1 score on a scaleStandard Deviation 0.3
BritePathSuicidal Ideation and BehaviorC-SSRS Category 8: Interrupted Attempt0 score on a scaleStandard Deviation 0
BritePathSuicidal Ideation and BehaviorC-SSRS Category 10: Completed Suicide0 score on a scaleStandard Deviation 0
BritePathSuicidal Ideation and BehaviorPHQ-9 Question 9 (ideation)1.1 score on a scaleStandard Deviation 1
Treatment As Usual (TAU)Suicidal Ideation and BehaviorC-SSRS Category 10: Completed Suicide0 score on a scaleStandard Deviation 0
Treatment As Usual (TAU)Suicidal Ideation and BehaviorPHQ-9 Question 9 (ideation)0 score on a scaleStandard Deviation 0
Treatment As Usual (TAU)Suicidal Ideation and BehaviorC-SSRS Category 7: Aborted Attempt0 score on a scaleStandard Deviation 0
Treatment As Usual (TAU)Suicidal Ideation and BehaviorC-SSRS Category 8: Interrupted Attempt0 score on a scaleStandard Deviation 0
Treatment As Usual (TAU)Suicidal Ideation and BehaviorC-SSRS Category 9: Actual Attempt (non-fatal)0 score on a scaleStandard Deviation 0
Secondary

Application Utilization

Use of the technical components of Guide2BRITE and the BRITEPortal for physicians will be monitored throughout Phase 1b. Utilization will be measured by the number of providers who have completed the Guide2BRITE onboarding process which includes steps 1, 1.2, 1.3, 2, 2.1, 2.2, 2.3, 2.4, 2.5, 3, 3.2, 4, 4.1, and 5.

Time frame: Up to 12 week follow-up

Population: 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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
BritePathApplication UtilizationStep 2.4Did not complete4 Participants
BritePathApplication UtilizationStep 1Completed28 Participants
BritePathApplication UtilizationStep 1Did not complete10 Participants
BritePathApplication UtilizationStep 1.2Completed28 Participants
BritePathApplication UtilizationStep 1.2Did not complete10 Participants
BritePathApplication UtilizationStep 1.3Completed34 Participants
BritePathApplication UtilizationStep 1.3Did not complete4 Participants
BritePathApplication UtilizationStep 2Completed38 Participants
BritePathApplication UtilizationStep 2Did not complete0 Participants
BritePathApplication UtilizationStep 2.1Completed34 Participants
BritePathApplication UtilizationStep 2.1Did not complete4 Participants
BritePathApplication UtilizationStep 2.2Completed34 Participants
BritePathApplication UtilizationStep 2.2Did not complete4 Participants
BritePathApplication UtilizationStep 2.3Completed34 Participants
BritePathApplication UtilizationStep 2.3Did not complete4 Participants
BritePathApplication UtilizationStep 2.4Completed34 Participants
BritePathApplication UtilizationStep 2.5Completed34 Participants
BritePathApplication UtilizationStep 2.5Did not complete4 Participants
BritePathApplication UtilizationStep 3Completed33 Participants
BritePathApplication UtilizationStep 3Did not complete5 Participants
BritePathApplication UtilizationStep 3.2Completed32 Participants
BritePathApplication UtilizationStep 3.2Did not complete6 Participants
BritePathApplication UtilizationStep 4Completed38 Participants
BritePathApplication UtilizationStep 4Did not complete0 Participants
BritePathApplication UtilizationStep 4.1Completed31 Participants
BritePathApplication UtilizationStep 4.1Did not complete7 Participants
BritePathApplication UtilizationStep 5Completed15 Participants
BritePathApplication UtilizationStep 5Did not complete23 Participants
Secondary

Application Utilization

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

Time frame: Up to 12 week follow-up

Population: 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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
BritePathApplication UtilizationFirst distress levelCompleted24 Participants
BritePathApplication UtilizationFirst distress levelDid not complete14 Participants
BritePathApplication UtilizationSecond distress levelCompleted17 Participants
BritePathApplication UtilizationSecond distress levelDid not complete21 Participants
BritePathApplication UtilizationLearn to savorCompleted2 Participants
BritePathApplication UtilizationLearn to savorDid not complete36 Participants
BritePathApplication UtilizationReaching out to contactsCompleted9 Participants
BritePathApplication UtilizationReaching out to contactsDid not complete29 Participants
BritePathApplication UtilizationSoothe breatheCompleted8 Participants
BritePathApplication UtilizationSoothe breatheDid not complete30 Participants
BritePathApplication UtilizationSoothe guided meditationCompleted6 Participants
BritePathApplication UtilizationSoothe guided meditationDid not complete32 Participants
BritePathApplication UtilizationCrisis survival strategiesCompleted9 Participants
BritePathApplication UtilizationCrisis survival strategiesDid not complete29 Participants
BritePathApplication UtilizationDistract with happy thoughtsCompleted8 Participants
BritePathApplication UtilizationDistract with happy thoughtsDid not complete30 Participants
BritePathApplication UtilizationDistract exerciseCompleted4 Participants
BritePathApplication UtilizationDistract exerciseDid not complete34 Participants
BritePathApplication UtilizationSavorCompleted5 Participants
BritePathApplication UtilizationSavorDid not complete33 Participants
BritePathApplication UtilizationSoothe activities to help you sleepCompleted3 Participants
BritePathApplication UtilizationSoothe activities to help you sleepDid not complete35 Participants
Secondary

Cost Estimate for Implementation of BRITEPath Intervention

An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated. Outcome measure data below highlights the estimated cost of the intervention BRITEPath Intervention per participant, measures were based on estimates from staff and not on empirical data at the individual level.

Time frame: At 12 week follow up after Baseline

Population: 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.

ArmMeasureValue (MEAN)
BritePathCost Estimate for Implementation of BRITEPath Intervention457.43 dollars per participant
Secondary

Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow Up

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

Time frame: At 12 week follow up after Baseline

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow UpUse outpatient services29 Participants
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow UpUse school services4 Participants
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow UpUse ER services0 Participants
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow UpUse legal services0 Participants
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow UpUse inpatient services1 Participants
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow UpUse medications26 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow UpUse inpatient services0 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow UpUse outpatient services2 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow UpUse legal services0 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow UpUse school services0 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow UpUse medications2 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow UpUse ER services0 Participants
Secondary

Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow Up

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

Time frame: At 4 week follow up after Baseline

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow UpUse outpatient services31 Participants
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow UpUse school services19 Participants
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow UpUse ER services12 Participants
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow UpUse legal services0 Participants
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow UpUse inpatient services8 Participants
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow UpUse medications31 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow UpUse inpatient services0 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow UpUse outpatient services4 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow UpUse legal services0 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow UpUse school services4 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow UpUse medications2 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow UpUse ER services0 Participants
Secondary

Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at Baseline

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

Time frame: At Baseline phone visit

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at BaselineUse outpatient services32 Participants
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at BaselineUse school services18 Participants
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at BaselineUse ER services12 Participants
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at BaselineUse legal services0 Participants
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at BaselineUse inpatient services8 Participants
BritePathService Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at BaselineUse medications31 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at BaselineUse inpatient services0 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at BaselineUse outpatient services4 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at BaselineUse legal services0 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at BaselineUse school services4 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at BaselineUse medications2 Participants
Treatment As Usual (TAU)Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at BaselineUse ER services0 Participants
Secondary

Usability and Satisfaction

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

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.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
BritePathUsability and SatisfactionIf a friend were in need of mental health care, would you recommend BRITEPath?No, I don't think so3 Participants
BritePathUsability and SatisfactionIf a friend were in need of mental health care, would you recommend BRITEPath?Yes, I think so14 Participants
BritePathUsability and SatisfactionIf a friend were in need of mental health care, would you recommend BRITEPath?Yes, definitely9 Participants
BritePathUsability and SatisfactionIf a friend were in need of mental health care, would you recommend BRITEPath?Dissatisfied0 Participants
BritePathUsability and SatisfactionIf a friend were in need of mental health care, would you recommend BRITEPath?Satisfied0 Participants
BritePathUsability and SatisfactionIf a friend were in need of mental health care, would you recommend BRITEPath?Very Satisfied0 Participants
BritePathUsability and SatisfactionIf a friend were in need of mental health care, would you recommend BRITEPath?Really didn't help0 Participants
BritePathUsability and SatisfactionIf a friend were in need of mental health care, would you recommend BRITEPath?Yes, somewhat0 Participants
BritePathUsability and SatisfactionIf a friend were in need of mental health care, would you recommend BRITEPath?Yes, a great deal0 Participants
BritePathUsability and SatisfactionHow satisfied were you with the amount of help you received?No, I don't think so0 Participants
BritePathUsability and SatisfactionHow satisfied were you with the amount of help you received?Yes, I think so0 Participants
BritePathUsability and SatisfactionHow satisfied were you with the amount of help you received?Yes, definitely0 Participants
BritePathUsability and SatisfactionHow satisfied were you with the amount of help you received?Dissatisfied1 Participants
BritePathUsability and SatisfactionHow satisfied were you with the amount of help you received?Satisfied18 Participants
BritePathUsability and SatisfactionHow satisfied were you with the amount of help you received?Very Satisfied7 Participants
BritePathUsability and SatisfactionHow satisfied were you with the amount of help you received?Really didn't help0 Participants
BritePathUsability and SatisfactionHow satisfied were you with the amount of help you received?Yes, somewhat0 Participants
BritePathUsability and SatisfactionHow satisfied were you with the amount of help you received?Yes, a great deal0 Participants
BritePathUsability and SatisfactionHave the services you received help you to deal more effectively with your problem?No, I don't think so0 Participants
BritePathUsability and SatisfactionHave the services you received help you to deal more effectively with your problem?Yes, I think so0 Participants
BritePathUsability and SatisfactionHave the services you received help you to deal more effectively with your problem?Yes, definitely0 Participants
BritePathUsability and SatisfactionHave the services you received help you to deal more effectively with your problem?Dissatisfied0 Participants
BritePathUsability and SatisfactionHave the services you received help you to deal more effectively with your problem?Satisfied0 Participants
BritePathUsability and SatisfactionHave the services you received help you to deal more effectively with your problem?Very Satisfied0 Participants
BritePathUsability and SatisfactionHave the services you received help you to deal more effectively with your problem?Really didn't help2 Participants
BritePathUsability and SatisfactionHave the services you received help you to deal more effectively with your problem?Yes, somewhat20 Participants
BritePathUsability and SatisfactionHave the services you received help you to deal more effectively with your problem?Yes, a great deal4 Participants
Secondary

Usability and Satisfaction

Satisfaction with the technical components of interventions will be assessed through the certain questions from the Post System Satisfaction and Usability Questionnaire (PSSUQ). The PSSUQ is 19 items with response options ranging from 1 to 7 where 1=strongly disagree and 7=strongly agree. The PSSUQ has sub-scores derived from subsets of the questions which reflect system usefulness, information quality, and interface quality. Questions from sub-domains were chosen to tailor the questioning to this particular intervention.

Time frame: At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools)

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.

ArmMeasureGroupValue (MEAN)Dispersion
BritePathUsability and SatisfactionOverall, I am satisfied with how easy it is to use the BRITE app5.7 score on a scaleStandard Deviation 1.4
BritePathUsability and SatisfactionThe information provided with the BRITE app was clear6.2 score on a scaleStandard Deviation 1.2
BritePathUsability and SatisfactionThe information provided in the BRITE app such as notifications to rate my mood was clear6.1 score on a scaleStandard Deviation 1
BritePathUsability and SatisfactionThe information provided during the onboarding with my therapist was clear6.5 score on a scaleStandard Deviation 0.8
BritePathUsability and SatisfactionI liked interacting with the BRITE app program5.8 score on a scaleStandard Deviation 1
BritePathUsability and SatisfactionI needed to learn a lot of things before I could get going with the BRITE app1.8 score on a scaleStandard Deviation 1.2

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026