Disruptive Mood Dysregulation Disorder Research
Title: Enhanced Support for Behavioral Barriers to Learning: An Evaluation of the SCHOOL STARS Program
Principal investigator: Courtney M. Brown, MD
Children’s Hospital Medical Center
This small pilot study will enroll children ages 5-12 with disruptive behavior problems at school. These children and their families will be offered an enhanced model of primary care, which includes pre-visit record review, standardized content of primary care visits, post-visit care coordination by the primary care team, and coordination of services between the primary care team and the school. We hypothesize that children receiving this enhanced model of care will achieve better behavioral outcomes at both school and home.
Title: Interpersonal Psychotherapy for Youth With Severe Mood Dysregulation
Principal investigator: Leslie Miller, MD
Johns Hopkins University
This research is being conducted to learn more about how to help teenagers with a sad or angry mood and emotional responses out of proportion to what would be expected in a situation. Together these symptoms are called Severe Mood Dysregulation (SMD), a research diagnosis, or disruptive mood dysregulation disorder (DMDD), a newer clinical diagnosis. Currently, there is no standard treatment for teens that have SMD/DMDD. These teens usually receive medication and some type of talk therapy. This research is being done to compare two types of talk therapy to see which is most effective in helping teens with SMD/DMDD. Investigators will compare treatment as usual (TAU) with Interpersonal Psychotherapy for Youth with Mood and Behavior Dysregulation (IPT-MBD). Investigators do not know if TAU and IPT-MBD work just as well or if one is better than the other. When this study is over, investigators hope there will be a better idea of how to study treatments for teens with SMD/DMDD.
For those participants who receive IPT-MBD, are prescribed an antipsychotic, and have significant improvement in symptoms, investigators will gradually taper the antipsychotic dose.
Title: Adapting DBT for Children With DMDD: Pilot RCT
Principal Investigator: Francheska Perepletchikova, PhD
Weill Cornell Medical College
White Plains, NY
This study examines the 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 a lower drop-out rate and higher treatment attendance and satisfaction. Further, DBT-C, as compared to TAU, will have a significantly greater reduction in symptoms of Disruptive Mood Dysregulation Disorder, including verbal and behavioral outbursts and angry/irritable mood.
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 the feasibility of DBT-C by evaluating the drop-out rates, number of sessions attended, and treatment satisfaction and any differences in these rates by groups, as well as therapist treatment adherence and competence.
Hypothesis 1: The attendance rate in DBT-C, as compared to TAU, will be at least 10% higher, and the 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 ratings 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 the 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 the efficacy of DBT-C in reducing the need for higher-level services.
Hypothesis 4: Children in DBT-C condition compared to TAU will have significantly fewer psychiatric hospitalization, emergency room visits, the total number of days inpatient, and residential care placements (on the Services Assessment Form).
Exploratory Aim 5: Examine whether parent emotion regulation moderates 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.