BRITEPath- Phase 2

NCT04672798 | Completed Results

• 2 other identifiers: STUDY20110359P50MH115838-02
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 6

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.

Conditions

Depression; Suicidal Ideation

Keywords

depression; suicidal ideation; anxiety; treatment; app; safety planning; provider

Outcome Measures

Primary Outcomes (8)

• 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.

  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 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.

  At 12 week follow up after Baseline

• 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.

  At 4 week follow up after Baseline

• 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.

  At 12 week follow up after Baseline

• 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.

  At 4 week follow up after Baseline

• 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.

  At 12 week follow up after Baseline

• 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.

  4 week follow up

• 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.

  12 week follow up

Secondary Outcomes (7)

• Application Utilization-BRITE App Use by Participants

  Up to 12 week follow up

• Application Utilization-Number of Participants With Provider Who Completed Guide2BRITE Onboarding Process

  Up to 12 week follow up

• Cost Estimate for Implementation of BRITEPath Intervention

  At 12 week follow up after Baseline

• 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)

• 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)

Study Arms (2)

BRITEPath

EXPERIMENTAL

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

Treatment As Usual (TAU)

ACTIVE COMPARATOR

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

Behavioral: Treatment As Usual (TAU)

Interventions

BRITEPath BEHAVIORAL

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.

BRITEPath

Treatment As Usual (TAU) BEHAVIORAL

Participants in this group will receive usual care from their mental health care provider.

Treatment As Usual (TAU)

Eligibility Criteria

• Age: 12 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (6)

Henry Ford Health System

Detroit, Michigan, 48126, United States

Location

Northwell Hospital

Hyde Park, New York, 11040, United States

Location

Children's Community Pediatrics (CCP-Moon) of Children's Hospital of Pittsburgh of UPMC

Moon Township, Pennsylvania, 15108, United States

Location

STAR- Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Children's Community Pediatrics (CCP- Wexford) of Children's Hospital of Pittsburgh of UPMC

Wexford, Pennsylvania, 15090, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Depression; Suicidal Ideation; Anxiety Disorders; Alzheimer Disease

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Limitations and Caveats

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. The impact of treatment on individuals who dropped out of treatment and on those lost during follow-up is unknown.

Results Point of Contact

• Title: Dr. Stephanie Stepp
• Organization: University of Pittsburgh

steppsd@upmc.edu

412-715-5447

Study Officials

• Stephanie Stepp, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• David Brent, MD

  University of Pittsburgh

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be masked to the intervention condition at follow-up assessment time points.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Psychology

Model Details: This study will use a parallel study design, where participants are randomized into two groups, BRITEPath or TAU, and will receive interventions in parallel.

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: November 5, 2020
• Primary Completion: March 23, 2022
• Study Completion: July 31, 2022
• Last Updated: June 5, 2023
• Results First Posted: June 5, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (6)