Disruptive Mood Dysregulation Disorder Clinical Trial
Official title:
Adapting Dialectical Behavior Therapy for Children With Disruptive Mood Dysregulation Disorder: Pilot Randomized Clinical Trial
NCT number | NCT01862549 |
Other study ID # | 1205012350 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2013 |
Est. completion date | December 2016 |
Verified date | February 2019 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 43 |
Est. completion date | December 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 12 Years |
Eligibility |
Inclusion Criteria: 1. Ages 7 years 0 months to 12 years 11 months 2. Meet criteria for Disruptive Mood Dysregulation Disorder on DSM-IV 3. Stabilized on psychiatric medication (at least 6 weeks). 4. 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: 1. Documented cognitive disability ( if records are not available will use < 85 IQ on Wechsler Intelligence Scale for Children-IV Information and Block Design subtests). 2. Current diagnosis of a psychotic disorder (on K-SADS-PL) 3. Pervasive Developmental Disorder (on K-SADS-PL) 4. Child in the English as Second Language program at school and/or caregivers have language difficulties as per self-report 5. Child is in state custody. 6. As consistent with DMDD diagnosis, child's co-morbid conditions better account for disruptive mood. |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medical College | White Plains | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Attendance and drop-out rate measure | 32 weeks | ||
Primary | Therapy Satisfaction Questionnaire | 32 weeks | ||
Primary | Therapist Satisfaction Questionaire | 32 weeks | ||
Primary | Psychosocial Treatment Compliance Scale | 32 weeks | ||
Secondary | Clinical Global Impression Scale | pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up | ||
Secondary | Mood Symptoms Questionnnaire | pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up | ||
Secondary | Children Coping Strategies Checklist | pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up | ||
Secondary | Emotion Regulation Checklist | pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up | ||
Secondary | Child Behavior Checklist | pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up | ||
Secondary | Social Skills Rating Scale | pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up | ||
Secondary | Measure of Aggression, Violence and Rage in Children | pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up | ||
Secondary | Affective Reactivity Index | pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up | ||
Secondary | Columbia Suicide and Self-Injury Serevity Rating Scale | pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up | ||
Secondary | Services Assessment Form | pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up | ||
Secondary | Difficulties in Emotion Regulation Scale | pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up | ||
Secondary | Parental Response to Children's Negative Emotions Scale | pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up |
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