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BRITEPath- Phase 2

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ClinicalTrials.gov Identifier: NCT04672798
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : December 22, 2020
Sponsor:
Collaborators:
Kaiser Foundation Research Institute
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Stephanie Stepp, University of Pittsburgh

Brief Summary:

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

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


Condition or disease Intervention/treatment Phase
Depression Suicidal Ideation Behavioral: BRITEPath Behavioral: Treatment As Usual (TAU) Not Applicable

Detailed Description:

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 will utilize a 1:1 randomization scheme to randomize participants to receive BRITEPath intervention or Treatment as Usual (TAU).

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will use a parallel study design, where participants are randomized into two groups, BRITEPath or TAU, and will receive interventions in parallel.
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessors will be masked to the intervention condition at follow-up assessment time points.
Primary Purpose: Health Services Research
Official Title: The Center for Enhancing Treatment & Utilization for Depression and Emergent Suicidality Phase 2-Study 3-BRITEPath
Actual Study Start Date : November 5, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: BRITEPath

Participants will receive the components in BRITEPath from a mental health (MH) clinical trained by the study staff/PI's on how to implement BRITE safety planning with fidelity.

First, the MH clinician will review possible barriers to implementation of the safety plan and problem-solve appropriately with patient and parent(s); (2) BRITE is the emotion regulation/safety planning app loaded on the patient's smartphone that populated with support from Guide2BRITE; and (3) BRITEBoard, a clinician dashboard that shows app use, change in distress and symptoms ratings, and can be used for shared decision making with parents, patients, and PCPs. Clinicians will review adolescent's skill development and app content with parents. Prior to discharge or following acute increases in suicide risk.

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

Active Comparator: Treatment As Usual (TAU)
Participants in the TAU group will receive treatment from their mental health clinician which may include safety planning.
Behavioral: Treatment As Usual (TAU)
Participants in this group will receive usual care from their mental health care provider.




Primary Outcome Measures :
  1. Depression Severity [ Time Frame: At in office screening 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 a 9 items assessment with scoring ranging from 0-27. The higher the score, the more severe the depression symptoms are. A score of 0-4= no depression; 5-9= mild depression; 10-14= moderate depression; 15-19= moderately severe depression; 20-27= severe depression symptoms.

  2. 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 a 9 items assessment with scoring ranging from 0-27. The higher the score, the more severe the depression symptoms are. A score of 0-4= no depression; 5-9= mild depression; 10-14= moderate depression; 15-19= moderately severe depression; 20-27= severe depression symptoms.

  3. 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 a 9 items assessment with scoring ranging from 0-27. The higher the score, the more severe the depression symptoms are. A score of 0-4= no depression; 5-9= mild depression; 10-14= moderate depression; 15-19= moderately severe depression; 20-27= severe depression symptoms.

  4. 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 a 9 items assessment with scoring ranging from 0-27. The higher the score, the more severe the depression symptoms are. A score of 0-4= no depression; 5-9= mild depression; 10-14= moderate depression; 15-19= moderately severe depression; 20-27= severe depression symptoms.

  5. Suicidal Ideation and Behavior [ Time Frame: At Baseline phone visit ]
    Suicide attempt & ideation will be measured through Columbia Suicide Severity Rating Scale (C-SSRS). Assign score of 0 if no ideation is present. A "yes" answer any time during treatment to 1 of 5 suicidal ideation questions (Categories 1-5). A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 6-10). Suicidal ideation or behavior: A "yes" answer any time during treatment to any of 1 of 10 suicidal ideation/behavior questions (Categories 1-10). Category 1- Wish to be Dead 2- Non-specific Active Suicidal Thoughts 3- Active Suicidal Ideation w/ Any Methods (Not Plan) w/O Intent to Act 4- Active Suicidal Ideation w/ Some Intent to Act w/O Specific Plan 5- Active Suicidal Ideation w/ Specific Plan & Intent 6- Preparatory Acts/Behavior 7 Aborted Attempt 8- Interrupted Attempt 9- Actual Attempt (non-fatal) 10- Completed Suicide. Any score greater than 0 is important/may indicate need for intervention.

  6. Suicidal Ideation and Behavior [ Time Frame: At 4 week follow up after Baseline ]
    Suicide attempt & ideation will be measured through Columbia Suicide Severity Rating Scale (C-SSRS). Assign score of 0 if no ideation is present. A "yes" answer any time during treatment to 1 of 5 suicidal ideation questions (Categories 1-5). A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 6-10). Suicidal ideation or behavior: A "yes" answer any time during treatment to any of 1 of 10 suicidal ideation/behavior questions (Categories 1-10). Category 1- Wish to be Dead 2- Non-specific Active Suicidal Thoughts 3- Active Suicidal Ideation w/ Any Methods (Not Plan) w/O Intent to Act 4- Active Suicidal Ideation w/ Some Intent to Act w/O Specific Plan 5- Active Suicidal Ideation w/ Specific Plan & Intent 6- Preparatory Acts/Behavior 7 Aborted Attempt 8- Interrupted Attempt 9- Actual Attempt (non-fatal) 10- Completed Suicide. Any score greater than 0 is important/may indicate need for intervention.

  7. Suicidal Ideation and Behavior [ Time Frame: At 12 week follow up after Baseline ]
    Suicide attempt & ideation will be measured through Columbia Suicide Severity Rating Scale (C-SSRS). Assign score of 0 if no ideation is present. A "yes" answer any time during treatment to 1 of 5 suicidal ideation questions (Categories 1-5). A "yes" answer any time during treatment to any 1 of the 5 suicidal behavior questions (Categories 6-10). Suicidal ideation or behavior: A "yes" answer any time during treatment to any of 1 of 10 suicidal ideation/behavior questions (Categories 1-10). Category 1- Wish to be Dead 2- Non-specific Active Suicidal Thoughts 3- Active Suicidal Ideation w/ Any Methods (Not Plan) w/O Intent to Act 4- Active Suicidal Ideation w/ Some Intent to Act w/O Specific Plan 5- Active Suicidal Ideation w/ Specific Plan & Intent 6- Preparatory Acts/Behavior 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.

  8. 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 functioning. The higher the score, the more problems the respondent associates with the prompt/sub domain.

  9. 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 functioning. The higher the score, the more problems the respondent associates with the prompt/sub domain.

  10. 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 functioning. The higher the score, the more problems the respondent associates with the prompt/sub domain.


Secondary Outcome Measures :
  1. Application Utilization [ Time Frame: At Baseline phone visit ]
    Use of the technical components of interventions and web portals for BRITEPath with be monitored throughout Phase 2. Utilization will be measured by the number and proportion of adolescents, parents, and providers who have engaged with the application over time.

  2. Application Utilization [ Time Frame: At 4 week follow up after baseline ]
    Use of the technical components of interventions and web portals for BRITEPath with be monitored throughout Phase 2. Utilization will be measured by the number and proportion of adolescents, parents, and providers who have engaged with the application over time.

  3. Application Utilization [ Time Frame: At 12 week follow up after baseline ]
    Use of the technical components of interventions and web portals for BRITEPath with be monitored throughout Phase 2. Utilization will be measured by the number and proportion of adolescents, parents, and providers who have engaged with the application over time.

  4. Cost Effectiveness [ Time Frame: At Baseline phone visit ]
    The following information on the incremental cost effectiveness of BRITEPath and its component interventions will be gathered from the Electronic Health Record (EHR) and the Child and Adolescent Service Assessment (CASA): (a) the direct costs of the intervention, including intervention (labor, equipment, supplies, facilities); (b) the total treatment as usual service use and expense for each participant in the study arm using EHR and CASA data; and (c) family costs (out-of-pocket expenses, parent missed time from work). The EHR data will supplement the information gathered in the CASA or replace missing entries to determine cost effectiveness.

  5. Cost Effectiveness [ Time Frame: At 4 week follow up after Baseline ]
    The following information on the incremental cost effectiveness of BRITEPath and its component interventions will be gathered from the Electronic Health Record (EHR) and the Child and Adolescent Service Assessment (CASA): (a) the direct costs of the intervention, including intervention (labor, equipment, supplies, facilities); (b) the total treatment as usual service use and expense for each participant in the study arm using EHR and CASA data; and (c) family costs (out-of-pocket expenses, parent missed time from work). The EHR data will supplement the information gathered in the CASA or replace missing entries to determine cost effectiveness.

  6. Cost Effectiveness [ Time Frame: At 12 week follow up after Baseline ]
    The following information on the incremental cost effectiveness of BRITEPath and its component interventions will be gathered from the Electronic Health Record (EHR) and the Child and Adolescent Service Assessment (CASA): (a) the direct costs of the intervention, including intervention (labor, equipment, supplies, facilities); (b) the total treatment as usual service use and expense for each participant in the study arm using EHR and CASA data; and (c) family costs (out-of-pocket expenses, parent missed time from work). The EHR data will supplement the information gathered in the CASA or replace missing entries to determine cost effectiveness.

  7. 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) ]
    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?; How satisfied are you with the amount of help you received?; Have the services you received helped you to deal more effectively with your problems?" The response options include: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely

  8. Satisfaction with Technical Components [ 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) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Youth aged 12-26yo
  2. Own a device (e.g. smartphone, iPod, tablet) with capability to download BRITE app
  3. Biological or adoptive parent is willing to provide informed consent for teen to participate
  4. Youth speaks and understands English
  5. 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
  6. Family agrees to see an (embedded) MH therapist at the practice
  7. 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:

  1. Non English speaking
  2. No parent willing to provide informed consent
  3. No cell phone capability of downloading BRITE app
  4. Is currently experiencing mania or psychosis
  5. Evidence of an intellectual or developmental disorder (IDD)
  6. Life threatening medical condition that requires immediate treatment (including emergent suicidality, homicidally, abuse/neglect, or other mental or physical condition)
  7. Other cognitive or medical condition preventing youth from understanding study and/or participating.
  8. Currently receiving MH treatment/currently satisfied with treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04672798


Contacts
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Contact: Brandie George-Milford, MA 412246562 georgeba2@upmc.edu

Locations
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United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48126
Contact: Melissa Hendriks, MD    800-436-7936    MHENDRI2@hfhs.org   
United States, New York
Northwell Hospital Recruiting
Hyde Park, New York, United States, 11040
Contact: Vera Feuer, MD    718-470-8038    VFeuer@northwell.edu   
Principal Investigator: Vera Feuer, MD         
United States, Pennsylvania
Children's Community Pediatrics (CCP-Moon) of Children's Hospital of Pittsburgh of UPMC Recruiting
Moon, Pennsylvania, United States, 15108
Contact: Pamela Schoemer, MD    724-934-3334      
Contact: Brad Karmer, MD    7249343334      
STAR- Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kim Poling, LCSW    412-246-5617    polingKD@upmc.edu   
Children's Community Pediatrics (CCP- Wexford) of Children's Hospital of Pittsburgh of UPMC Recruiting
Wexford, Pennsylvania, United States, 15090
Contact: Pamela Schoemer, MD    724-934-3334      
Contact: Brad Karmer, MD    724-934-3334      
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Molly Adrian, PhD    206-987-2164    Molly.adrian@seattlechildrens.org   
Principal Investigator: Molly Adrian, PhD         
Sponsors and Collaborators
University of Pittsburgh
Kaiser Foundation Research Institute
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Stephanie Stepp, PhD University of Pittsburgh
Study Director: David Brent, MD University of Pittsburgh
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Responsible Party: Stephanie Stepp, Associate Professor of Psychiatry and Psychology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04672798    
Other Study ID Numbers: STUDY20110359
P50MH115838-02 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All requests for study data will follow NIMH's data sharing and data use policies. 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.
Time Frame: These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication
Access Criteria: In addition to public access to the NDCT, data can also be accessed by contacting ETUDES Center investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephanie Stepp, University of Pittsburgh:
depression
suicidal ideation
anxiety
treatment
app
safety planning
provider
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Suicidal Ideation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Suicide
Self-Injurious Behavior