Adapting DBT for Children With DMDD: Pilot RCT
Condition: Disruptive Mood Dysregulation Disorder
Study type: Interventional

Summary: 
      This study examines feasibility and preliminary efficacy of Dialectical Behavior Therapy
      adapted to children (DBT-C). DBT-C as compared to treatment-as-usual (TAU) is hypothesized to
      have lower drop-out rate, and higher treatment attendance and satisfaction. Further, DBT-C as
      compared to TAU will have significantly greater reduction in symptoms of Disruptive Mood
      Dysregulation disorder, including verbal and behavioral outbursts and angry/irritable mood.
    

Detailed description: 
      Specific Aims:

      I: Conduct Pilot Randomized Clinical Trial to evaluate feasibility and efficacy of DBT for
      children with Disruptive Mood Dysregulation Disorder (DMDD) as compared with
      Treatment-As-Usual (TAU) (up to 30 children and caregivers in DBT-C and up to 30 children and
      caregivers in the treatment as usual comparison condition).

      Specific Aim 1: Examine feasibility of DBT-C by evaluating the drop-out rates, number of
      session attended, and treatment satisfaction and any differences in these rates by groups, as
      well as therapist treatment adherence and competence.

      Hypothesis 1: Attendance rate in DBT-C, as compared to TAU, will be at least 10% higher and
      drop-out rate will be at least 10% lower (primary feasibility endpoint). Further, DBT-C, as
      compared with TAU will have significantly higher treatment satisfaction rating by subjects
      (on the child and caregiver Therapy Satisfaction Questionnaires), and by therapists (on
      Therapist Satisfaction Scale), and higher patient compliance (on Psychosocial Treatment
      Compliance Scale). Therapist treatment adherence and competence as measured by DBT-C
      Treatment Integrity Scale, will not fall below 80%.

      Specific Aim 2: Examine preliminary efficacy of DBT-C in reducing symptoms of Disruptive Mood
      Dysregulation Disorder.

      Hypothesis 2: Children in DBT-C condition as compared to TAU will have significantly greater
      reduction in irritability, anger, aggression, temper outbursts, and mood instability (on
      Clinical Global Impression - Improvement scale [primary categorical outcome] Exploratory Aim
      3: Examine efficacy of DBT-C in improving adaptive coping skills, emotional and behavioral
      regulation, social skills, and reducing aggressive behaviors, affective reactivity,
      non-suicidal self-harm behaviors, suicidal ideations, suicidal attempts, and non-suicidal
      self-harm urges.

      Hypothesis 3: Children in DBT-C condition as compared to TAU will have significantly greater
      improvement in adaptive coping skills (on the Children's Coping Strategies Checklist),
      emotional and behavioral regulation (on the Emotion Regulation Checklist and Child Behavior
      Checklist - Dysregulation Syndrome) and social skills (on the Social Skills Rating Scale),
      and significantly greater reduction in aggressive behaviors (Measure of Aggression, Violence
      and Rage in Children), affective reactivity (on the Affective Reactivity Index and Mood
      Symptoms Questionnaire). ), and greater reduction in non-suicidal self-harm behaviors (in
      Columbia Suicide and Self-Injury Severity Rating Scale [C-SSIS] self-injurious behaviors),
      suicidal ideations (in the C-SSRS suicidal ideation classification category), suicidal
      attempts (in C-SSIS suicide attempts category), and non-suicidal self-harm urges (in C-SSIS
      self-injurious urges, no suicidal intent category).

      Exploratory Aim 4: Examine efficacy of DBT-C in reducing the need for higher level services.

      Hypothesis 4: Children in DBT-C condition as compared to TAU will have significantly fewer
      psychiatric hospitalization, emergency room visits, total number of days inpatient, and
      residential care placements (on the Services Assessment Form).

      Exploratory Aim 5: Examine whether parent emotion regulation moderate the relationship
      between intervention and outcomes, while parent ability to effectively cope with children's
      negative emotions and children's coping skills and emotion regulation mediate outcomes.

      Hypothesis 5: Parents' own emotion regulation (on the Difficulties in Emotion Regulation
      Scale) will moderate outcomes and parents' ability to effectively cope with children's
      negative emotions (on the Parental Response to Children's Negative Emotions), children coping
      skills (on the Children's Coping Strategies Checklist) and emotion regulation (on Emotion
      Regulation Checklist) will mediate outcomes.
    

Intervention name(s): Dialectical Behavior Therapy for children; Treatment as Usual
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment