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

NCT04000399 | Completed Results DMC

• 2 other identifiers: Study18120080P50MH115838-02
• Study Type: interventional
• Target: 43
• 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

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  At 12 week follow up after Baseline

Secondary Outcomes (8)

• Application Utilization

  Up to 12 week follow-up

• Application Utilization

  Up to 12 week follow-up

• Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at Baseline

  At Baseline phone visit

• Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow Up

  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

  At 12 week follow up after Baseline

Study Arms (1)

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.

Behavioral: BRITEPath

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

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 12-26 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

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 (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

Sponsors & Collaborators

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

Study Sites (6)

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

Wesley Family Services

Pittsburgh, Pennsylvania, 15221, 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

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior

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, 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.

Results Point of Contact

• Title: Stephanie D. Stepp, PhD
• Organization: University of Pittsburgh

steppsd@upmc.edu

4127155447

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: NA
• Masking: NONE
• Masking Details: Outcomes assessors will be masked to the intervention condition at follow-up assessment timepoints. See notes on pre-assignment details in participant flow related to study model single arm vs. multi arm.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Psychology

Model Details: 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.

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 27, 2019
• Study Start: August 6, 2019
• Primary Completion: February 9, 2021
• Study Completion: February 9, 2021
• Last Updated: August 8, 2022
• Results First Posted: August 8, 2022

Record last verified: 2022-07

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)