Clinical trial NCT04000399: BRITEPath, Component 3 of iCHART (Integrated Care to Help At-Risk Teens)
Official title: BRITEPath, Component 3 of iCHART (Integrated Care to Help At-Risk Teens)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Suicidal Ideation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Kaiser Foundation Research Institute
name: National Institute of Mental Health (NIMH)
First posted: 2019-06-27
Enrollment: 43
Sex: ALL
Minimum age (years): 12
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Depression Severity
timeFrame: At Baseline phone visit
measure: Depression Severity
timeFrame: At 4 week follow up after Baseline
measure: Depression Severity
timeFrame: At 12 week follow up after Baseline
measure: Suicidal Ideation and Behavior
timeFrame: At Baseline phone visit
measure: Suicidal Ideation and Behavior
timeFrame: At 4 week follow up after Baseline
measure: Suicidal Ideation and Behavior
timeFrame: At 12 week follow up after Baseline
measure: Quality of Life and Social/Emotional Functioning
timeFrame: At Baseline phone visit
measure: Quality of Life and Social/Emotional Functioning
timeFrame: At 4 week follow up after Baseline
measure: Quality of Life and Social/Emotional Functioning
timeFrame: At 12 week follow up after Baseline
Secondary outcomes:
measure: Application Utilization
timeFrame: Up to 12 week follow-up
measure: Application Utilization
timeFrame: Up to 12 week follow-up
measure: Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at Baseline
timeFrame: At Baseline phone visit
measure: Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 4 Week Follow Up
timeFrame: At 4 week follow up after Baseline
measure: Service Utilization (Outpatient, School, ER, Legal, Inpatient, Medication) - BRITEPath vs. Treatment as Usual (TAU) at 12 Week Follow Up
timeFrame: At 12 week follow up after Baseline
measure: Usability and Satisfaction
timeFrame: 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)
measure: Usability and Satisfaction
timeFrame: 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)
measure: Cost Estimate for Implementation of BRITEPath Intervention
timeFrame: At 12 week follow up after Baseline
Other outcomes:
Locations:
city: Hyde Park
country: United States
facility: Northwell Hospital
state: New York
city: Moon
country: United States
facility: Children's Community Pediatrics (CCP-Moon) of Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: STAR-Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Wesley Family Services
state: Pennsylvania
city: Wexford
country: United States
facility: Children's Community Pediatrics (CCP-Wexford) of Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: University of Pittsburgh
name: Stephanie Stepp, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: David Brent, MD
role: STUDY_DIRECTOR
References: