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临床试验/NCT01117753
NCT01117753已完成不适用

Stage II Research on Outpatient Treatment for Adolescents With Comorbidity

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2009年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
2
主要终点
Mental Health

研究概览

简要总结

Adolescent substance abuse results in significant negative outcomes and extraordinary costs for youths, their families, communities, and society. Moreover, rates of psychiatric comorbidity among substance abusing youth range from 25% up to 82%, and youths with a dual diagnosis are more than twice as costly to treat compared to those with no comorbidity. The applicant principal investigator recently completed a pilot project funded by the National Institute on Drug Abuse focused on developing and piloting a psychosocial treatment specifically for youth presenting for outpatient treatment with co-occurring substance use and internalizing (i.e., mood and/or anxiety) problems. Results were promising with the experimental group exhibiting significantly less substance use and more rapid reductions in anxiety and depressive symptoms compared to the control group. The proposed research is a randomized clinical trial (RCT) to compare the experimental treatment (OutPatient Treatment for Adolescents; OPT-A) to an "active placebo" on key clinical indices from pre-treatment through 18 months. The proposed RCT (n = 160) employs the treatment manual, quality assurance protocol, and therapist training protocol developed and successfully tested in the pilot study, to evaluate the efficacy of OPT-A for youth referred to outpatient treatment of co-occurring substance use and internalizing problems. The following outcomes will be evaluated: drug use; mental health; behavioral, school, peer, and family functioning; and consumer satisfaction. The intervention addresses one of the more prevalent and most challenging, costly, and understudied presenting problems among adolescent outpatients. If successful, this research could provide a considerable contribution in the treatment field for youth with co-occurring substance use and internalizing disorders.

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

入选标准

  • 10 to 17 years of age
  • Residing with at least one adult caregiver who serves as a parent figure
  • In need of treatment for a Substance Abuse or Dependence Disorder
  • In need of treatment for an Axis I Mood Disorder and/or Anxiety Disorder

排除标准

  • Pervasive Developmental Disorder
  • Active Psychotic Disorder
  • Severe or profound mental retardation

研究组 & 干预措施

OPT-A

Experimental

OPT-A is an outpatient family-based treatment for co-occurring substance use and internalizing disorders

干预措施: OutPatient Treatment for Adolescents (OPT-A) (Behavioral)

Treatment as Usual

Active Comparator

Treatment as usual in a community based mental health center

干预措施: Treatment As Usual (Behavioral)

结局指标

主要结局

Mental Health

时间窗: baseline and 1-, 2-, 3-, 6-, 12-, and 18-month follow-up

Substance use

时间窗: baseline and 1-, 2-, 3-, 6-, 12-, and 18-month follow-up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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