Adapting Dialectical Behavior Therapy for Children With Disruptive Mood Dysregulation Disorder: Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Therapist Satisfaction Questionaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Dialectical Behavior Therapy for children (Behavioral)
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.
干预措施: Treatment as Usual (Behavioral)
结局指标
主要结局
Therapist Satisfaction Questionaire
时间窗: 32 weeks
Psychosocial Treatment Compliance Scale
时间窗: 32 weeks
Attendance and drop-out rate measure
时间窗: 32 weeks
Therapy Satisfaction Questionnaire
时间窗: 32 weeks
次要结局
- Measure of Aggression, Violence and Rage in Children(pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up)
- Children Coping Strategies Checklist(pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up)
- Emotion Regulation Checklist(pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up)
- Child Behavior Checklist(pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up)
- Clinical Global Impression Scale(pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up)
- Mood Symptoms Questionnnaire(pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up)
- Affective Reactivity Index(pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up)
- Columbia Suicide and Self-Injury Serevity Rating Scale(pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up)
- Social Skills Rating Scale(pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up)
- Services Assessment Form(pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up)
- Difficulties in Emotion Regulation Scale(pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up)
- Parental Response to Children's Negative Emotions Scale(pre-treatment, 8, 16, 24, 32 weeks, 3-month follow-up)