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Intensive Outpatient Services for Teens (INVEST)

2018年1月21日 更新者:Anthony Spirito、Brown University

Intensive Outpatient Protocol for High Risk Suicidal Teens

This study will identify the effectiveness of an intensive treatment program for teens who are at high risk for harming themselves.

研究概览

详细说明

Suicidal ideation and behavior are the primary reasons for emergency psychiatric care and inpatient psychiatric hospitalization in this country. These expensive contacts with the health care system effectively address acute suicidality for many adolescents but there is a significant subset of suicidal patients that have continued suicidality. This study will target teens that are at risk for re-hospitalization based on continued suicidal ideation, their mood and another risk factor such as self-harm or substance use. These risk factors have been shown to increase risk for continued suicidal behavior and expensive contacts with the health care system. This protocol has been designed to determine whether Intensive Cognitive Behavioral Therapy (CBT), which was designed to treat adolescents with a mood disorder, suicidal ideation, and substance use, will result in better treatment outcomes compared to standard care in the community. The Intensive CBT condition will be delivered by a team of two licensed mental health therapists over the course of one year and will work with both the teen and parent. The standard care condition will receive treatment in the community. One hundred-and fifty adolescents (38 a year) will be recruited from several inpatient and partial hospital locations. Each adolescent will receive a thorough baseline assessment to determine whether they are appropriate for the study and will be assigned to either the Intensive CBT condition or treatment within the community. Both groups of teens will receive follow-up assessments at 6, 12, and 18 months to identify how they are doing over time.

研究类型

介入性

注册 (实际的)

140

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Rhode Island
      • Providence、Rhode Island、美国、02912
        • Brown University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 18年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Current Mood Disorder and suicidal ideation and one of the following
  • NSSI
  • Suicide Attempt
  • Substance Use

Exclusion Criteria:

  • Intelligence Quotient < 80
  • Diagnosis of psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, bulimia nervosa or anorexia nervosa
  • Adolescent use of illicit "hard" substances such as cocaine, heroine, and opiates 13 or more times over the prior 90 days

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Intensive Outpatient CBT
Intensive CBT for both parents and adolescents as well as family sessions to increase communication.
Sessions will be delivered 1-2 times a week for the first 4-6 weeks, based on need, and then weekly until 6 months. Therapy can continue up until one year.
其他名称:
  • Intensive CBT for High Risk Teens with a mood disorder
有源比较器:Standard Care
Standard Treatment in the Community
Treatment at step-down facilities
其他名称:
  • 照常治疗

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Suicide attempts
大体时间:Measured at 18 months from Baseline
Self-report by parents or teens of a suicide attempt occurring in the follow-up period
Measured at 18 months from Baseline

次要结果测量

结果测量
措施说明
大体时间
Depressed mood as assessed by the Children's Depression Rating Scale - Revised
大体时间:Measured at 18 months from Baseline
Depressed mood as determined by clinical interview
Measured at 18 months from Baseline

其他结果措施

结果测量
措施说明
大体时间
Other self harm behaviors including Nonsuicidal self-injury (NSSI) substance abuse
大体时间:Measures 18 months from Baseline
Self report of behaviors considered self-harming including self-inflicted behaviors such as cutting with no suicidal intent or excessive substance use with negative consequences to the individual
Measures 18 months from Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2012年9月1日

初级完成 (实际的)

2017年10月1日

研究完成 (实际的)

2018年1月1日

研究注册日期

首次提交

2012年11月13日

首先提交符合 QC 标准的

2012年11月19日

首次发布 (估计)

2012年11月26日

研究记录更新

最后更新发布 (实际的)

2018年1月23日

上次提交的符合 QC 标准的更新

2018年1月21日

最后验证

2018年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1R01MH097703-01 (美国 NIH 拨款/合同)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Intensive Outpatient CBT的临床试验

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