BRITEPath, Component 3 of iCHART (Integrated Care to Help At-Risk Teens)
Condition: Depression; Suicidal Ideation
MeSH terms: Suicidal Ideation
Study type: Interventional

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.
    

Intervention name(s): BRITEPath
Intervention type(s): Behavioral
Intervention description(s): 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 model: Single Group Assignment
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.
Masking: None (Open Label)
Primary purpose: Health Services Research