DepressionNCT04000399

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

A study testing BRITEPath in people with Depression and Suicidal Ideation, run by University of Pittsburgh at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 to 26 years
Conditions the study is for: Depression, Suicidal Ideation
What is being tested?: BRITEPath
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 6 sitesUnited States
Study dates: 6 Aug 2019to 9 Feb 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 26 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Northwell Hospital
Hyde Park, New York, 11040
Children's Community Pediatrics (CCP-Moon) of Children's Hospital of Pittsburgh of UPMC
Moon Township, Pennsylvania, 15108
STAR-Center
Pittsburgh, Pennsylvania, 15213
Wesley Family Services
Pittsburgh, Pennsylvania, 15221
Seattle Children's Hospital
Seattle, Washington, 98105
Children's Community Pediatrics (CCP-Wexford) of Children's Hospital of Pittsburgh of UPMC
Wexford, Pennsylvania, 15090

Other trials in United States

About this study

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.

Read the 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.

Conditions: Depression, Suicidal Ideation
Being tested: BRITEPath
Medical subject headings: Depression, Suicidal Ideation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BRITEPathBehavioural
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.

Study groups in NCT04000399
Study group	Role	What they receive
BRITEPath	Experimental	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. Receives: Behavioral: BRITEPath

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At Baseline phone visit
Depression Severity
Total scores from the Patient Health Questionnaire (PHQ-9) will be used to assess depression severity, as a primary outcome. The PHQ-9 is 9 items with scoring ranging from 0-27. The higher the score, the more severe the depression symptoms are. A score of 0-4=no depression; 5-9=mild depression; 10-14=moderate depression; 15-19=moderately severe depression; 20-27=severe depression symptoms.
Measured: At 4 week follow up after Baseline
Depression Severity
Total scores from the Patient Health Questionnaire (PHQ-9) will be used to assess depression severity, as a primary outcome. The PHQ-9 is 9 items with scoring ranging from 0-27. The higher the score, the more severe the depression symptoms are. A score of 0-4=no depression; 5-9=mild depression; 10-14=moderate depression; 15-19=moderately severe depression; 20-27=severe depression symptoms.
Measured: At 12 week follow up after Baseline
Suicidal Ideation and Behavior
Suicidal attempt \& ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS) and the Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present and assign a score of 1 if ideation/behavior present. A "yes" answer any time during treatment to question 9 on the PHQ-9 indicates suicidal ideation. A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 7-10) on the C-SSRS. C-SSRS Categories 7-10 are as follows: 7-Aborted Attempt 8-Interrupted Attempt 9-Actual Attempt (non-fatal) 10-Completed Suicide. Any score greater than 0 is important/may indicate need for intervention.
Measured: At Baseline phone visit
Suicidal Ideation and Behavior
Suicidal attempt \& ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS) and the Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present and assign a score of 1 if ideation/behavior present. A "yes" answer any time during treatment to question 9 on the PHQ-9 indicates suicidal ideation. A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 7-10) on the C-SSRS. C-SSRS Categories 7-10 are as follows: 7-Aborted Attempt 8-Interrupted Attempt 9-Actual Attempt (non-fatal) 10-Completed Suicide. Any score greater than 0 is important/may indicate need for intervention.
Measured: At 4 week follow up after Baseline
Suicidal Ideation and Behavior
Suicidal attempt \& ideation will be measured through the Columbia Suicide Severity Rating Scale (C-SSRS) and the Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present and assign a score of 1 if ideation/behavior present. A "yes" answer any time during treatment to question 9 on the PHQ-9 indicates suicidal ideation. A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 7-10) on the C-SSRS. C-SSRS Categories 7-10 are as follows: 7-Aborted Attempt 8-Interrupted Attempt 9-Actual Attempt (non-fatal) 10-Completed Suicide. Any score greater than 0 is important/may indicate need for intervention.
Measured: At 12 week follow up after Baseline
Quality of Life and Social/Emotional Functioning
The Pediatric Quality of Life Inventory Version 4.0 (PedsQOL) will be used to assess overall quality of life and functioning, as a primary outcome. The PEDSQOL has 23 items and ranges in score from 0-92. It is broken down into 4 subdomains of physical functioning, emotional functioning, social functioning, and work/school (psychosocial) functioning. The higher the score, the more problems the respondent associates with the prompt/sub domain.
Measured: At Baseline phone visit
Quality of Life and Social/Emotional Functioning
The Pediatric Quality of Life Inventory Version 4.0 (PedsQOL) will be used to assess overall quality of life and functioning, as a primary outcome. The PEDSQOL has 23 items and ranges in score from 0-92. It is broken down into 4 subdomains of physical functioning, emotional functioning, social functioning, and work/school (psychosocial) functioning. The higher the score, the more problems the respondent associates with the prompt/sub domain.
Measured: At 4 week follow up after Baseline
Quality of Life and Social/Emotional Functioning
The Pediatric Quality of Life Inventory Version 4.0 (PedsQOL) will be used to assess overall quality of life and functioning, as a primary outcome. The PEDSQOL has 23 items and ranges in score from 0-92. It is broken down into 4 subdomains of physical functioning, emotional functioning, social functioning, and work/school (psychosocial) functioning. The higher the score, the more problems the respondent associates with the prompt/sub domain.
Measured: At 12 week follow up after Baseline

Secondary outcomes (8)

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.
Measured: Up to 12 week follow-up
Application Utilization
Use of the technical components of Guide2BRITE and the BRITEPortal for physicians will be monitored throughout Phase 1b. Utilization will be measured by the number of providers who have completed the Guide2BRITE onboarding process which includes steps 1, 1.2, 1.3, 2, 2.1, 2.2, 2.3, 2.4, 2.5, 3, 3.2, 4, 4.1, and 5.
Measured: Up to 12 week follow-up
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at Baseline
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
Measured: At Baseline phone visit
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow Up
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
Measured: At 4 week follow up after Baseline
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow Up
The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.
Measured: At 12 week follow up after Baseline
Usability and Satisfaction
Satisfaction to BRITEPath will be assessed through questions developed by investigators to understand experience with the program. Questions investigators have adapted from literature reviews on satisfaction include:
"If a friend were in need of mental health care for depression or suicidal thoughts or behaviors, would you recommend BRITEPath to help him/her manage symptoms? with answer options of: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely
How satisfied are you with the amount of help you received? with answer options of: Dissatisfied; Satisfied; Very Satisfied
Have the services you received helped you to deal more effectively with your problems? with answer options of: Really didn't help; Yes, somewhat; Yes, a great deal.
Measured: At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools)
Usability and Satisfaction
Satisfaction with the technical components of interventions will be assessed through the certain questions from the Post System Satisfaction and Usability Questionnaire (PSSUQ). The PSSUQ is 19 items with response options ranging from 1 to 7 where 1=strongly disagree and 7=strongly agree. The PSSUQ has sub-scores derived from subsets of the questions which reflect system usefulness, information quality, and interface quality. Questions from sub-domains were chosen to tailor the questioning to this particular intervention.
Measured: At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools)
Cost Estimate for Implementation of BRITEPath Intervention
An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated. Outcome measure data below highlights the estimated cost of the intervention BRITEPath Intervention per participant, measures were based on estimates from staff and not on empirical data at the individual level.
Measured: At 12 week follow up after Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Aug 20199 Feb 2021

First posted27 Jun 2019
Study start6 Aug 2019
Primary completion9 Feb 2021
Study completion9 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DepressionStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
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.
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04000399
Sponsor's protocol ID: Study18120080
Other IDs: P50MH115838-02
Status last verified: Jul 2022
First submitted: 24 Jun 2019
Last updated: 8 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies, including those funded by the innovation contests. These analytic datasets may also include derived variables with documentation. Our form datasets will include original case report forms, a detailed codebook of variable names, value labels, and programming formats and all study documentation including the protocol and manual of procedures. For descriptive/raw data, study investigators/study staff will upload to NIMH's National Database for Clinical Trials Related to Mental Health Illness (NDCT) on a semi-annual basis all analyzed data being uploaded prior to primary paper publication.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BRITEPath, Component 3 of iCHART (Integrated Care to Help At-Risk Teens)
ClinicalTrials.gov ID: NCT04000399
Acronym / sponsor ID: Study18120080
Conditions: Depression, Suicidal Ideation
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)
Study start: 6 Aug 2019 (actual)
Primary completion: 9 Feb 2021 (actual)
Study completion: 9 Feb 2021 (actual)
First posted: 27 Jun 2019 (actual)
Results: Posted 8 Aug 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Delivery of Interventions:

Assignment of Interventions:

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.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
BRITEPath	Experimental	Behavioral: BRITEPathParticipants 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.

Who may qualify

Ages: 12 to 26 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BRITEPathBRITEPath 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.	Behavioural	BRITEPath

Primary outcome

Depression Severity
Time frame: 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.
Depression Severity
Time frame: 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.
Depression Severity
Time frame: 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.
Suicidal Ideation and Behavior
Time frame: 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.
Suicidal Ideation and Behavior
Time frame: 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.
Suicidal Ideation and Behavior
Time frame: 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.
Quality of Life and Social/Emotional Functioning
Time frame: 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.
Quality of Life and Social/Emotional Functioning
Time frame: 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.
Quality of Life and Social/Emotional Functioning
Time frame: 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.

8 secondary outcomes

Application Utilization
Time frame: Up to 12 week follow-up
Application Utilization
Time frame: Up to 12 week follow-up
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at Baseline
Time frame: At Baseline phone visit
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow Up
Time frame: At 4 week follow up after Baseline
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow Up
Time frame: At 12 week follow up after Baseline
Usability and Satisfaction
Time frame: At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools)
Usability and Satisfaction
Time frame: At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools)
Cost Estimate for Implementation of BRITEPath Intervention
Time frame: At 12 week follow up after Baseline

Results and safety

Results posted to the registry on 8 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BritePath	38	38
Treatment As Usual (TAU)	5	5

Primary outcome: Depression Severity

Time frame: At Baseline phone visit. Mean (Standard Deviation). Unit: score on a scale

Measure	BritePath n = 35	Treatment As Usual (TAU) n = 5
Value	12.9 (4.8)	9.2 (5.8)

Population analysed: 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.

Primary outcome: Depression Severity

Time frame: At 4 week follow up after Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	BritePath n = 32	Treatment As Usual (TAU) n = 4
Value	10.9 (6)	5.5 (1.3)

Population analysed: 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.

Primary outcome: Depression Severity

Time frame: At 12 week follow up after Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	BritePath n = 32	Treatment As Usual (TAU) n = 4
Value	10.4 (5.4)	9.5 (1.7)

Population analysed: 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.

Primary outcome: Suicidal Ideation and Behavior

Time frame: At Baseline phone visit. Mean (Standard Deviation). Unit: score on a scale

Measure	BritePath n = 35	Treatment As Usual (TAU) n = 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)

Population analysed: 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.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were assessed for adverse events at each timepoint (baseline, 4 week follow-up, 12 week follow-up).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BritePath	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Treatment As Usual (TAU)	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. The final completely de-identified dataset(s) will include demographic and clinical data at baseline, and primary and secondary outcomes for all studies, including those funded by the innovation contests. These analytic datasets may also include derived variables with documentation. Our form datasets will include original case report forms, a detailed codebook of variable names, value labels, and programming formats and all study documentation including the protocol and manual of procedures. For descriptive/raw data, study investigators/study staff will upload to NIMH's National Database for Clinical Trials Related to Mental Health Illness (NDCT) on a semi-annual basis all analyzed data being uploaded prior to primary paper publication.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephanie Stepp, PhD principal investigator

University of Pittsburgh

David Brent, MD study director

University of Pittsburgh

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BRITEPath in people with Depression and Suicidal Ideation, run by University of Pittsburgh at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression Severity (time frame: At Baseline phone visit). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04000399.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.