BRITEPath- Phase 2

Sponsor
University of Pittsburgh (Other)
Overall Status
Recruiting
CT.gov ID
NCT04672798
Collaborator
Kaiser Foundation Research Institute (Other), National Institute of Mental Health (NIMH) (NIH)
100
6
2
20.8
16.7
0.8

Study Details

Study Description

Brief Summary

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

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: BRITEPath
  • Behavioral: Treatment As Usual (TAU)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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.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 :
Nov 5, 2020
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Depression Severity [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Henry Ford Health System Detroit Michigan United States 48126
2 Northwell Hospital Hyde Park New York United States 11040
3 Children's Community Pediatrics (CCP-Moon) of Children's Hospital of Pittsburgh of UPMC Moon Pennsylvania United States 15108
4 STAR- Center Pittsburgh Pennsylvania United States 15213
5 Children's Community Pediatrics (CCP- Wexford) of Children's Hospital of Pittsburgh of UPMC Wexford Pennsylvania United States 15090
6 Seattle Children's Hospital Seattle Washington United States 98105

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stephanie Stepp, Associate Professor of Psychiatry and Psychology, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT04672798
Other Study ID Numbers:
  • STUDY20110359
  • P50MH115838-02
First Posted:
Dec 17, 2020
Last Update Posted:
May 10, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stephanie Stepp, Associate Professor of Psychiatry and Psychology, University of Pittsburgh
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2022