- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01862549
Adapting DBT for Children With DMDD: Pilot RCT
Adapting Dialectical Behavior Therapy for Children With Disruptive Mood Dysregulation Disorder: Pilot Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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White Plains, New York, United States, 10605
- Weill Cornell Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ages 7 years 0 months to 12 years 11 months
- Meet criteria for Disruptive Mood Dysregulation Disorder on DSM-IV
- Stabilized on psychiatric medication (at least 6 weeks).
- Able to be treated on the outpatient basis
Children with suicidal ideation, suicidal behavior and non-suicidal self-injury will be included (assessed using Columbia Suicide and Self-Injury Severity Rating Scale) unless other interventions are indicated (e.g., hospitalization, medication).
Exclusion Criteria:
- Documented cognitive disability ( if records are not available will use < 85 IQ on Wechsler Intelligence Scale for Children-IV Information and Block Design subtests).
- Current diagnosis of a psychotic disorder (on K-SADS-PL)
- Pervasive Developmental Disorder (on K-SADS-PL)
- Child in the English as Second Language program at school and/or caregivers have language difficulties as per self-report
- Child is in state custody.
- As consistent with DMDD diagnosis, child's co-morbid conditions better account for disruptive mood.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DBT for children
Dialectical Behavior Therapy for children is a 32 session intervention (it consists of 2 pre-treatment sessions and 30 treatment sessions; treatment sessions are to be delivered in 32 weeks total) with once per week meetings, including 30 min.
individual child therapy, 20 min.
meeting with a caregiver and 40 min. of skills training with both.
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Active Comparator: Treatment as Usual
Children in active comparison conditions will receive Treatment as Usual (TAU) that primarily consists of 32 weekly sessions of supportive individual psychotherapy and adjunctive family interventions.
Individual therapy included cognitive behavioral skills training (e.g., psychoeducation, cognitive modifications, thought blocking) and non-directive supportive therapy.
Family therapy includes parenting skills training (e.g., limit setting, reinforcement techniques), structuring household environment, and safety planning.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Attendance and drop-out rate measure
Time Frame: 32 weeks
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32 weeks
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Therapy Satisfaction Questionnaire
Time Frame: 32 weeks
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32 weeks
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Therapist Satisfaction Questionaire
Time Frame: 32 weeks
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32 weeks
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Psychosocial Treatment Compliance Scale
Time Frame: 32 weeks
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32 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical Global Impression Scale
Time Frame: pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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Mood Symptoms Questionnnaire
Time Frame: pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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Children Coping Strategies Checklist
Time Frame: pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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Emotion Regulation Checklist
Time Frame: pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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Child Behavior Checklist
Time Frame: pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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Social Skills Rating Scale
Time Frame: pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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Measure of Aggression, Violence and Rage in Children
Time Frame: pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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Affective Reactivity Index
Time Frame: pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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Columbia Suicide and Self-Injury Serevity Rating Scale
Time Frame: pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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Services Assessment Form
Time Frame: pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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Difficulties in Emotion Regulation Scale
Time Frame: pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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Parental Response to Children's Negative Emotions Scale
Time Frame: pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up
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Collaborators and Investigators
Investigators
- Principal Investigator: Francheska Perepletchikova, PhD, Weill Medical College of Cornell University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1205012350
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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