跳至主要内容
临床试验/NCT01528020
NCT01528020已完成不适用

Treatment of Suicidal and Self-Injurious Adolescents With Emotional Dysregulation

University of Washington2 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
173
试验地点
2
主要终点
Suicide Events

研究概览

简要总结

Suicide is the third leading cause of death among adolescents in the US yet there is a paucity of research on effective treatments for this population. The primary aim of the research described in this application is to evaluate the efficacy of dialectical behavior therapy (DBT) for suicidal adolescents. DBT has an empirical track record with suicidal adults of reducing the incidence, frequency and medical risk of suicide attempts and non-suicidal self-injuries among individuals meeting criteria for borderline personality disorder (BPD). While DBT is widely used in the community with suicidal adolescents, particularly those with difficulties characteristic of BPD such as poor emotion regulation and impulse control, no randomized trial of DBT with suicidal adolescents has ever been conducted. And, while non-randomized trials indicate that the intervention is both safe and effective, without a randomized trial the investigators simply do not know whether DBT for suicidal adolescents is efficacious or not. Given the severity of the problem and the lack of alternative treatments for high risk adolescents, addressing this question is of great importance. The second aim of the research is to analyze mediators of reduced suicidal and self-injurious behaviors in adolescents. 170 adolescents at two sites (Seattle and Los Angeles) will be randomized to DBT or Individual and Supportive Group Therapy (IGST). Both treatments include 6 months of individual and group treatment and adolescents and a parent complete 5 assessments over a 1-year period.

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
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Current suicide ideation;
  • More than one intentional self-injury or suicide attempt;
  • Has difficulties with emotion and impulsive behavior or has characteristics similar to borderline personality disorder;
  • 13-17 years of age;
  • At least one family member or responsible adult available to participate in assessments and treatment.

排除标准

  • Has significant developmental delays
  • Has significant current mania, psychosis or life threatening anorexia
  • Has a court order for treatment

结局指标

主要结局

Suicide Events

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marsha Linehan

Professor

University of Washington

研究点 (2)

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