Adapting Dialectical Behavior Therapy for Children in Residential Care: Pilot Randomized Clinical Trial With Children With Severe Emotional and Behavioral Dysregulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Attendance Form
研究概览
简要总结
I: Conduct Pilot Randomized Clinical Trial of Dialectical Behavior Therapy for children (DBT-C) in residential as compared with Treatment-As-Usual (TAU) (60 children in DBT-C and 60 children in the comparison condition).
II: Finalize therapist training manuals and educational materials to guide selection, training, and supervision of treatment providers.
详细描述
Specific Aim 1: Examine feasibility of DBT-C by evaluating response rate in treatment attendance, treatment satisfaction, and any differences in these rates by groups.
Hypothesis 1: DBT-C will be equivalent to TAU in attendance rate and will have significantly greater treatment satisfaction rating by subjects, as well as by therapists and milieu staff.
Specific Aim 2: Examine efficacy of DBT-C as compared to TAU in reducing internalizing and externalizing symptoms.
Hypothesis 2: Children in DBT-C condition as compared to TAU will have significantly fewer internalizing and externalizing symptoms.
Specific Aim 3: Examine efficacy of DBT-C in improving adaptive coping, emotion regulation, risk taking, and social skills, and reducing depression.
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
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age between 6 years 0 months and 12 years 11 months;
- •in residential care at Green Chimneys;
- •projected length of stay is at least 8 months.
排除标准
- •pervasive developmental disorder;
- •psychotic disorder;
- •mental retardation; (all as per psychiatric evaluation at Green Chimneys);
- •in care or custody of the Department of Social Services (DSS);
- •caregivers do not speak English.
研究组 & 干预措施
DBT for children
Dialectical Behavior Therapy adapted for children
干预措施: DBT for children (Behavioral)
Enhanced Supportive-Educational Therapy
Enhanced Treatment-As-Usual, including supportive-educational model, cognitive-behavioral skills and parent management training
干预措施: Enhanced Supportive-Educational therapy (Behavioral)
结局指标
主要结局
Attendance Form
时间窗: post-treatment at 30 weeks
次要结局
- Social Skills Rating Scale(pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up)
- Mood and Feelings Questionnaire(pre-treatment, weeks 6, 12, 18, 24 and 30 of treatment at at 3 and 6 months follow-up)
- Children's Coping Strategies Checklist(pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up)
- Pleasure Scale for Children(pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up)
- Therapy Satisfaction Questionnaire(week 30)
- Therapist Satisfaction Scale(week 30)
- Balloon Analog Risk Task(pre-treatment, week 6, 12, 18, 24, 30 of treatment and at 3 and 6 months follow-up)
- Emotion Regulation Checklist(pre-treatment, weeks 12, 24 and 30 of treatment at at 3 and 6 months follow-up)
- Incident Report(pre-treatment, weeks 6, 12, 18, 24 and 30 of treatment at at 3 and 6 months follow-up)
- Psychosocial Treatment Compliance Scale(week 30)
- Child Behavior Checklist(at pre-treatment, 6, 12, 18, 24, 30 weeks of treatment, and at 3 and 6 months follow-up)
- Difficulty with Emotion Regulation Scale(pre-treatment)
- Milieu Staff Satisfaction Questionnaire(every 6 months)