Technology Enhanced Family Treatment
Condition: Mood Disorders; Bipolar Disorder; Major Depression
MeSH terms: Bipolar Disorder; Mood Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators propose to enhance the scalability of family-focused therapy (FFT), a
      12-session evidence-based therapy for youth at high risk for mood disorders, through
      augmentation with a novel mobile phone application called MyCoachConnect (MCC). In
      adolescents with mood instability who have a parent with bipolar or major depressive
      disorder, clinicians in community clinics will conduct FFT sessions (consisting of
      psychoeducation and family skills training) supplemented by weekly MCC "real time"
      assessments of moods and family relationships; based on results of these assessments and the
      family's progress in treatment, clinicians will then push personalized informational and
      coaching alerts regarding the practice of communication and problem-solving skills. The
      investigators hypothesize that the augmented version of FFT (FFT-MCC) will be more effective
      than FFT without coaching/informational alerts in altering treatment targets and in
      stabilizing youths' mood symptoms and quality of life.
    

Detailed description: 
      The investigative group has shown in several randomized trials that family-focused therapy
      (FFT) for symptomatic youth at high-risk for bipolar disorder - consisting of psychoeducation
      and family communication and problem solving skills training - is an effective adjunct to
      pharmacotherapy in hastening symptomatic recovery. However, between 50%-60% of high-risk
      youth still have residual mood symptoms and functional impairment after 18 weeks of FFT. In
      prior studies, two constructs have emerged as predictors of lack of response to treatment:
      mood instability in the child and expressed emotion (EE) in parents (i.e., frequent critical
      comments or hostility). In adolescents (ages 12-18) with a parent with bipolar disorder or
      major depressive disorder, the investigators hypothesize that augmenting FFT with frequent
      and targeted interventions in the home setting through a Smartphone app (MyCoachConnect, or
      MCC) will (a) have a greater and more rapid impact than standard FFT on the targeted
      mechanisms of mood instability in adolescents and EE in parents, and (b) as a result, enhance
      symptom resolution and functioning in adolescents. To be eligible, adolescents must score
      high on parent-rated measures of mood instability, and have at least one parent who is
      high-EE by speech sample coding criteria. The MCC app will record weekly open speech samples
      from parents and children and daily and weekly mood ratings from adolescents. The app
      assessments will be fed back to the FFT clinician, who will use this information to "push"
      recommendations for mood regulation, communication, and problem-solving strategies (linked to
      the FFT modules) for parents and youth. In year 1, the investigators will conduct an open
      trial (n=25) to determine (a) the feasibility and acceptability of FFT with mobile coaching
      (FFT-MCC), as given by clinicians in community settings, and (b) associations between
      online/speech feature proxies of the targets (mood instability and EE as measured weekly by
      MCC) and standard measures of the targets. In years 2 and 3 the investigators will conduct a
      60-case randomized clinical trial in which families are assigned to FFT with MCC skills
      coaching or FFT with MCC assessments only, with no skills coaching. The primary hypotheses
      are that FFT-MCC will be acceptable to parents, adolescents and clinicians, and more
      effective than FFT without MCC coaching in engaging the targets of mood instability and EE
      and promoting improvements in adolescents' mood symptoms and quality of life over 27 weeks.
      The study will facilitate the translation of a technological augmentation to an
      evidence-based family intervention, with the goal of increasing treatment access among
      families with mood disorders.
    

Intervention name(s): Family-Focused Treatment with MCC App
Intervention type(s): Behavioral
Intervention description(s): 12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigation is comparing youth who receive family-focused treatment with the MyCoachConnect (FFT-MCC) mobile application (assessments, skill training, psychoeducation) to youth who receive FFT plus only the assessment components of the MCC app (FFT-Assess) on symptomatic outcome and family functioning over 27 weeks.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Family Therapy