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临床试验/NCT01547052
NCT01547052
已完成
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Adapting Dialectical Behavior Therapy for Children in Residential Care: Pilot Randomized Clinical Trial With Children With Severe Emotional and Behavioral Dysregulation

Weill Medical College of Cornell University1 个研究点 分布在 1 个国家目标入组 47 人2011年4月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Childhood Aggression
发起方
Weill Medical College of Cornell University
入组人数
47
试验地点
1
主要终点
Attendance Form
状态
已完成
最后更新
7年前

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. Hypothesis 3: Children in DBT-C Training condition as compared to TAU will have significantly greater improvement in adaptive coping skills, emotion regulation, risk taking and impulsivity and social skills, and reducing depressive symptoms. Specific Aim 4: Examine efficacy of DBT-C in reducing the frequency of critical incidents. Hypothesis 4: Children in DBT-C condition as compared to TAU will have significantly fewer critical incidents, including psychiatric hospitalization, emergency room visits, total number of days inpatient, suicidal ideations and attempts, self-harm behaviors, sexual acting out, running away, stealing, police involvement, etc.

注册库
clinicaltrials.gov
开始日期
2011年4月
结束日期
2016年9月
最后更新
7年前
研究类型
Interventional
研究设计
Parallel
性别
Male

研究者

入排标准

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.

结局指标

主要结局

Attendance Form

时间窗: post-treatment at 30 weeks

次要结局

  • Milieu Staff Satisfaction Questionnaire(every 6 months)
  • 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)

研究点 (1)

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