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
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Rhode Island
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Providence、Rhode Island、美国、02912
- Brown University
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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
不
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 |
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实验性的:Intensive Outpatient CBT
Intensive CBT for both parents and adolescents as well as family sessions to increase communication.
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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:
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有源比较器:Standard Care
Standard Treatment in the Community
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Treatment at step-down facilities
其他名称:
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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 |
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Suicide attempts
大体时间:Measured at 18 months from Baseline
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Self-report by parents or teens of a suicide attempt occurring in the follow-up period
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Measured at 18 months from Baseline
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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
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Depressed mood as determined by clinical interview
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Measured at 18 months from Baseline
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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
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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
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Measures 18 months from Baseline
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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
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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University Hospital TuebingenRobert Bosch Gesellschaft für Medizinische Forschung mbH招聘中
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VA Office of Research and DevelopmentCorporal Michael J. Crescenz VA Medical Center招聘中
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Psychiatric Research Unit, Region Zealand, DenmarkAarhus University Hospital; University of Copenhagen; Mental Health Centre Copenhagen完全的
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NMP Medical Research InstituteWarwick Research Services完全的