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BRITEPath- Phase 2

Primary Purpose

Depression, Suicidal Ideation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BRITEPath
Treatment As Usual (TAU)
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring depression, suicidal ideation, anxiety, treatment, app, safety planning, provider

Eligibility Criteria

12 Years - 26 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henry Ford Health System
  • Northwell Hospital
  • Children's Community Pediatrics (CCP-Moon) of Children's Hospital of Pittsburgh of UPMC
  • STAR- Center
  • Children's Community Pediatrics (CCP- Wexford) of Children's Hospital of Pittsburgh of UPMC
  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BRITEPath

Treatment As Usual (TAU)

Arm Description

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.

Participants in the TAU group will receive treatment from their mental health clinician which may include safety planning.

Outcomes

Primary Outcome Measures

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 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.
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 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.
Suicidal Ideation and Behavior
Suicide attempt & ideation is measured through Columbia Suicide Severity Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present or answer is "No", assign a score of 1 if ideation/behavior present or "Yes." A "Yes" to question 9 (score=1) on PHQ-9 indicates suicidal ideation. Suicidal ideation or behavior= "yes" answer to any of suicidal behavior questions (Categories 7-10) on the CSSRS. 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 and may indicate worse outcomes.
Suicidal Ideation and Behavior
Suicide attempt & ideation is measured through Columbia Suicide Severity Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present or answer is "No", assign a score of 1 if ideation/behavior present or "Yes." A "Yes" to question 9 (score=1) on PHQ-9 indicates suicidal ideation. Suicidal ideation or behavior= "yes" answer to any of suicidal behavior questions (Categories 7-10) on the CSSRS. 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 and may indicate worse outcomes.
Quality of Life and Social/Emotional Functioning
Pediatric Quality of Life Inventory Version 4 assesses quality of life and functioning. Items on the Pediatric Quality of Life Generic Core Scales are reverse scored & transformed to 0-100 scale. Higher scores indicate better health related quality of life. 0 ("Never") = 100; 1 ("Almost Never") = 75; 2 ("Sometimes") = 50; 3 ("Often") = 25; 4 ("Almost Always") = 0. The total score is Sum of all items over number of items answered.
Quality of Life and Social/Emotional Functioning
Pediatric Quality of Life Inventory Version 4 assesses quality of life and functioning. Items on the Pediatric Quality of Life Generic Core Scales are reverse scored & transformed to 0-100 scale. Higher scores indicate better health related quality of life. 0 ("Never") = 100; 1 ("Almost Never") = 75; 2 ("Sometimes") = 50; 3 ("Often") = 25; 4 ("Almost Always") = 0. The total score is Sum of all items over number of items answered.
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
The Child and Adolescent Service Assessment (CASA) collects service utilization of all participants to determine the amount of services accessed. The CASA response data displayed are those who responded positively that they received the service. Those who said yes to receiving the service is scored as a 1. Multiple participants can say yes to more than 1 service.
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
The Child and Adolescent Service Assessment (CASA) collects service utilization of all participants to determine the amount of services accessed. The CASA response data displayed are those who responded positively that they received the service. Those who said yes to receiving the service is scored as a 1. Multiple participants can say yes to more than 1 service.

Secondary Outcome Measures

Application Utilization-BRITE App Use by Participants
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 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.
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Use of the technical components of interventions and web portals for BRITEPath with be monitored throughout Phase 2. 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. Each step includes text field components of a standard safety plan that needs to be completed. Providers who clicked "next" at each step after filling in the text boxes were counted.
Cost Estimate for Implementation of BRITEPath Intervention
An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilities) 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 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?" The response options include: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely
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: "How satisfied are you with the amount of help you received?" The response options include: Very Dissatisfied, Dissatisfied, Satisfied, Very Satisfied
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: "Have the services you received helped you to deal more effectively with your problem?" The response options include: Seemed to make things worse, Really didn't help, Yes, somewhat, or Yes, a great deal.
Satisfaction With Technical Components
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.

Full Information

First Posted
December 11, 2020
Last Updated
May 10, 2023
Sponsor
University of Pittsburgh
Collaborators
Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04672798
Brief Title
BRITEPath- Phase 2
Official Title
The Center for Enhancing Treatment & Utilization for Depression and Emergent Suicidality Phase 2-Study 3-BRITEPath
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
March 23, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Suicidal Ideation
Keywords
depression, suicidal ideation, anxiety, treatment, app, safety planning, provider

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Outcomes assessors will be masked to the intervention condition at follow-up assessment time points.
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BRITEPath
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual (TAU)
Arm Type
Active Comparator
Arm Description
Participants in the TAU group will receive treatment from their mental health clinician which may include safety planning.
Intervention Type
Behavioral
Intervention Name(s)
BRITEPath
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment As Usual (TAU)
Intervention Description
Participants in this group will receive usual care from their mental health care provider.
Primary Outcome Measure Information:
Title
Depression Severity
Description
Total scores from the Patient Health Questionnaire (PHQ-9) will be used to assess depression severity, as a primary outcome. The PHQ-9 is 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.
Time Frame
At 4 week follow up after Baseline
Title
Depression Severity
Description
Total scores from the Patient Health Questionnaire (PHQ-9) will be used to assess depression severity, as a primary outcome. The PHQ-9 is 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.
Time Frame
At 12 week follow up after Baseline
Title
Suicidal Ideation and Behavior
Description
Suicide attempt & ideation is measured through Columbia Suicide Severity Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present or answer is "No", assign a score of 1 if ideation/behavior present or "Yes." A "Yes" to question 9 (score=1) on PHQ-9 indicates suicidal ideation. Suicidal ideation or behavior= "yes" answer to any of suicidal behavior questions (Categories 7-10) on the CSSRS. 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 and may indicate worse outcomes.
Time Frame
At 4 week follow up after Baseline
Title
Suicidal Ideation and Behavior
Description
Suicide attempt & ideation is measured through Columbia Suicide Severity Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9). Assign score of 0 if no ideation/behavior present or answer is "No", assign a score of 1 if ideation/behavior present or "Yes." A "Yes" to question 9 (score=1) on PHQ-9 indicates suicidal ideation. Suicidal ideation or behavior= "yes" answer to any of suicidal behavior questions (Categories 7-10) on the CSSRS. 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 and may indicate worse outcomes.
Time Frame
At 12 week follow up after Baseline
Title
Quality of Life and Social/Emotional Functioning
Description
Pediatric Quality of Life Inventory Version 4 assesses quality of life and functioning. Items on the Pediatric Quality of Life Generic Core Scales are reverse scored & transformed to 0-100 scale. Higher scores indicate better health related quality of life. 0 ("Never") = 100; 1 ("Almost Never") = 75; 2 ("Sometimes") = 50; 3 ("Often") = 25; 4 ("Almost Always") = 0. The total score is Sum of all items over number of items answered.
Time Frame
At 4 week follow up after Baseline
Title
Quality of Life and Social/Emotional Functioning
Description
Pediatric Quality of Life Inventory Version 4 assesses quality of life and functioning. Items on the Pediatric Quality of Life Generic Core Scales are reverse scored & transformed to 0-100 scale. Higher scores indicate better health related quality of life. 0 ("Never") = 100; 1 ("Almost Never") = 75; 2 ("Sometimes") = 50; 3 ("Often") = 25; 4 ("Almost Always") = 0. The total score is Sum of all items over number of items answered.
Time Frame
At 12 week follow up after Baseline
Title
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Description
The Child and Adolescent Service Assessment (CASA) collects service utilization of all participants to determine the amount of services accessed. The CASA response data displayed are those who responded positively that they received the service. Those who said yes to receiving the service is scored as a 1. Multiple participants can say yes to more than 1 service.
Time Frame
4 week follow up
Title
Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication)
Description
The Child and Adolescent Service Assessment (CASA) collects service utilization of all participants to determine the amount of services accessed. The CASA response data displayed are those who responded positively that they received the service. Those who said yes to receiving the service is scored as a 1. Multiple participants can say yes to more than 1 service.
Time Frame
12 week follow up
Secondary Outcome Measure Information:
Title
Application Utilization-BRITE App Use by Participants
Description
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 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
Title
Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process
Description
Use of the technical components of interventions and web portals for BRITEPath with be monitored throughout Phase 2. 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. Each step includes text field components of a standard safety plan that needs to be completed. Providers who clicked "next" at each step after filling in the text boxes were counted.
Time Frame
Up to 12 week follow up
Title
Cost Estimate for Implementation of BRITEPath Intervention
Description
An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilities) 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
Title
Usability and Satisfaction
Description
Satisfaction to BRITEPath will be assessed through questions developed by investigators to understand experience with the program. Questions investigators have adapted from literature reviews on satisfaction include: "If a friend were in need of mental health care for depression or suicidal thoughts or behaviors, would you recommend BRITEPath to help him/her manage symptoms?" The response options include: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely
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)
Title
Usability and Satisfaction
Description
Satisfaction to BRITEPath will be assessed through questions developed by investigators to understand experience with the program. Questions investigators have adapted from literature reviews on satisfaction include: "How satisfied are you with the amount of help you received?" The response options include: Very Dissatisfied, Dissatisfied, Satisfied, Very Satisfied
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)
Title
Usability and Satisfaction
Description
Satisfaction to BRITEPath will be assessed through questions developed by investigators to understand experience with the program. Questions investigators have adapted from literature reviews on satisfaction include: "Have the services you received helped you to deal more effectively with your problem?" The response options include: Seemed to make things worse, Really didn't help, Yes, somewhat, or 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)
Title
Satisfaction With Technical Components
Description
Satisfaction with the technical components of interventions will be assessed through the certain questions from the Post System Satisfaction and Usability Questionnaire (PSSUQ). The PSSUQ is 19 items with response options ranging from 1 to 7 where 1= strongly disagree and 7= strongly agree. The PSSUQ has sub-scores derived from subsets of the questions which reflect system usefulness, information quality, and interface quality. Questions from sub-domains were chosen to tailor the questioning to this particular intervention.
Time Frame
At exit interview following week 4 study visit or week 12 study visit (depending on when youth attends mental health session that uses BRITEPath tools)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Youth aged 12-26yo 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 (including emergent suicidality, homicidally, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Stepp, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Brent, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Study Director
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Facility Name
Northwell Hospital
City
Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Children's Community Pediatrics (CCP-Moon) of Children's Hospital of Pittsburgh of UPMC
City
Moon
State/Province
Pennsylvania
ZIP/Postal Code
15108
Country
United States
Facility Name
STAR- Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Children's Community Pediatrics (CCP- Wexford) of Children's Hospital of Pittsburgh of UPMC
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
These data will be released to the NDCT soon after each project's "main outcomes" manuscript is accepted for publication
IPD Sharing Access Criteria
In addition to public access to the NDCT, data can also be accessed by contacting ETUDES Center investigators.

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BRITEPath- Phase 2

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