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临床试验/NCT01732601
NCT01732601已完成1 期

Intensive Outpatient Protocol for High Risk Suicidal Teens

Brown University2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2012年9月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
140
试验地点
2
主要终点
Suicide attempts

研究概览

简要总结

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

详细描述

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
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Intensive Outpatient CBT

Experimental

Intensive CBT for both parents and adolescents as well as family sessions to increase communication.

干预措施: Intensive Outpatient CBT (Behavioral)

Standard Care

Active Comparator

Standard Treatment in the Community

干预措施: Standard Care (Behavioral)

结局指标

主要结局

Suicide attempts

时间窗: Measured at 18 months from Baseline

Self-report by parents or teens of a suicide attempt occurring in the follow-up period

次要结局

  • Depressed mood as assessed by the Children's Depression Rating Scale - Revised(Measured at 18 months from Baseline)

研究者

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

Anthony Spirito

Professor

Brown University

研究点 (2)

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