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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04000399
• Other study ID #: Study18120080
• Secondary ID: P50MH115838-02
• Status: Completed
• Phase: N/A
• Start date: August 6, 2019
• Est. completion date: February 9, 2021

Study information

• Verified date: July 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Delivery of Interventions:

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 utilized an open trial design. A stepped wedge design was originally proposed and efforts were made to adhere to this study design, however after a year of low recruitment and resultant recruitment sites pulling out the of the study, the overall study design was changed to an open trial. Additional recruitment sites were onboarded to the study and provided with the intervention arm in order to obtain feasibility data on the intervention components of the study. As a result of the change, there are some TAU participants included in this study. For reference a stepped wedge design involves the sequential random rollout of an intervention over two 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 investigators will pilot BRITEPath in community pediatric and mental health practices using a stepped wedge design (n =50 adolescents).

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.

Of note: Study investigators initially intended to do a cost analysis as a secondary outcome measure, but it was later decided that the analysis will not be done in this pilot phase of testing and will instead be completed during the Phase 2 RCT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 9, 2021
• Est. primary completion date: February 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 26 Years

Eligibility

Inclusion Criteria:

• 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

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 (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

Related Conditions & MeSH terms

• Depression
• Suicidal Ideation

Intervention

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.

Locations

Country	Name	City	State
United States	Northwell Hospital	Hyde Park	New York
United States	Children's Community Pediatrics (CCP-Moon) of Children's Hospital of Pittsburgh of UPMC	Moon	Pennsylvania
United States	STAR-Center	Pittsburgh	Pennsylvania
United States	Wesley Family Services	Pittsburgh	Pennsylvania
United States	Seattle Children's Hospital	Seattle	Washington
United States	Children's Community Pediatrics (CCP-Wexford) of Children's Hospital of Pittsburgh of UPMC	Wexford	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Kaiser Foundation Research Institute, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Application Utilization	Use of the technical components of the BRITEApp for adolescents and young adults will be monitored throughout Phase 1b. 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.	Up to 12 week follow-up
Secondary	Application Utilization	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.	Up to 12 week follow-up
Secondary	Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at Baseline	The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.	At Baseline phone visit
Secondary	Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow Up	The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.	At 4 week follow up after Baseline
Secondary	Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow Up	The Child and Adolescent Service Assessment (CASA) will collect service utilization of all participants to determine the amount of services accessed in each treatment arm. An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) will be estimated and between the intervention costs and cost of services used from CASA, a comparison will be made and results published. The CASA response data displayed are those who responded positively that they received the service.	At 12 week follow up after Baseline
Secondary	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? with answer options of: No, definitely not; No, I don't think so; Yes, I think so; Yes, definitely; How satisfied are you with the amount of help you received? with answer options of: Dissatisfied; Satisfied; Very Satisfied; Have the services you received helped you to deal more effectively with your problems? with answer options of: Really didn't help; Yes, somewhat; Yes, a great deal.	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)
Secondary	Usability and Satisfaction	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.	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)
Secondary	Cost Estimate for Implementation of BRITEPath Intervention	An overall average of the cost of implementing the BRITEPath intervention (including labor, equipment, supplies, facilitates) 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.	At 12 week follow up after Baseline