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临床试验/NCT01381133
NCT01381133已完成3 期

Adolescent Outpatient and Continuing Care Study

Chestnut Health Systems2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2002年9月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
320
试验地点
2
主要终点
Change in Percentage of days abstinent from any alcohol and drugs

研究概览

简要总结

The purpose of this study was to evaluate the effectiveness and cost-effectiveness of two types of outpatient treatment with and without Assertive Continuing Care (ACC) for 320 adolescents with substance use disorders. Study participants were randomly assigned to one of four conditions: (a) Chestnut's Bloomington Outpatient Treatment (CBOP) without ACC; (b) CBOP with ACC; (c) Motivational Enhancement Therapy/Cognitive Behavior Therapy-7 session model (MET/CBT7) without ACC; and (d) MET/CBT7 with ACC. Based on prior quasi and experimental studies, the investigators hypothesized that MET/CBT would be more effective and cost-effective than CBOP in terms of increasing days abstinent and decreasing substance abuse problems. Additionally, the investigators hypothesized that the groups receiving ACC would have significantly better outcomes than the groups without ACC. Lastly, the investigators hypothesized that adding ACC to MET/CBT would be the most cost-effective option in terms of days abstinent.

详细描述

This study evaluated the effectiveness and cost-effectiveness of two types of outpatient treatment with and without Assertive Continuing Care (ACC) for 320 adolescents with substance use disorders. Study participants were randomly assigned to one of four conditions: (a) Chestnut's Bloomington Outpatient Treatment (CBOP) without ACC; (b) CBOP with ACC; (c) Motivational Enhancement Therapy/Cognitive Behavior Therapy-7 session model (MET/CBT7) without ACC; and (d) MET/CBT7 with ACC. All study conditions attained high rates of participant engagement and retention. Follow-up interviews were completed with over 90% of the adolescents at three, six, nine, and 12 months after treatment admission. There was a significant time by condition effect over 12 months, with CBOP having a slight advantage for average percentage of days abstinent. Unlike previous findings that ACC provided incremental effectiveness following residential treatment, there were no statistically significant findings with regard to the incremental effectiveness of ACC following outpatient treatment. Analysis of the costs of each intervention combined with its outcomes revealed that the most cost-effective condition was MET/CBT7 without ACC.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

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

  • 12-18 years old
  • met ASAM's (2001) Patient Placement Criteria for Level I outpatient treatment based on a substance abuse or dependence diagnosis and six dimensional admission criteria (i.e., severity of intoxication/withdrawal, physical health, emotional/behavioral health, treatment readiness, relapse potential, and recovery environment)
  • attended an admission appointment

排除标准

  • "stepped-down" from residential treatment and were therefore more severe than adolescents who entered outpatient treatment from the community
  • were recommended only for individual counseling, as both outpatient treatment conditions had group components
  • were a ward of the state
  • did not have a parent/guardian present during admission to outpatient treatment
  • appeared to have insufficient mental capacity to provide informed consent
  • did not speak English with sufficient ability to understand study procedures and instruments

结局指标

主要结局

Change in Percentage of days abstinent from any alcohol and drugs

时间窗: Baseline and 3, 6, 9, and 12 months post-baseline

Change in Days abstinent from alcohol alone

时间窗: Baseline and 3, 6, 9, and 12 months post-baseline

Change in Substance use problems

时间窗: Baseline and 3, 6, 9, and 12 months post-baseline

Measured using the Substance Problem Scale of the Global Appraisal of Individual Needs

Change in Recovery status

时间窗: 12 months post-baseline

Being in recovery at the end of the study was defined as living in the community (vs. being incarcerated, or residing in inpatient treatment or other controlled environment) and reporting no past month substance use, abuse, or dependence problems at the 12 month interview. Urine samples were collected as described above in Section 2.4.2, and when an adolescent reported being in recovery but the urine test result suggested a false-negative self-report, data were re-coded to show the adolescent as not being in recovery.

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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