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临床试验/NCT02125539
NCT02125539已完成2 期

Navigating My Journey (NmJ): A Relapse Prevention Program for Adolescents -- Field Trial

Inflexxion, Inc.2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
160
试验地点
2
主要终点
Change in Substance Use Across Time

研究概览

简要总结

The purpose of this study is to provide a comprehensive evaluation of the new, Navigating my Journey program for adolescents receiving treatment in an outpatient substance abuse center.

The primary hypotheses are that, relative to the control condition, Navigating my Journey will be associated with significantly higher motivation, higher self-efficacy, improved relapse coping skills, and lower substance use. The secondary hypotheses are that, relative to the control condition, Navigating my Journey will be associated with increased therapeutic alliances with counselors.

详细描述

The randomized, control trial will compare clients receiving treatment in an outpatient substance abuse center in the following two conditions -- (1) Experimental: Navigating my Journey (includes 12 core lessons and 8 supplemental lessons); and (2) Attention Control (treatment as usual plus online health information) -- using a longitudinal design.

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
None

入排标准

年龄范围
13 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • currently meeting with a counselor in the study at least twice per month during the next 3 months
  • age 13 to 21
  • ability to read and speak English
  • have drugs and/or alcohol as their primary or secondary substance used
  • have completed detox as necessary
  • an active email account.

排除标准

  • 未提供

结局指标

主要结局

Change in Substance Use Across Time

时间窗: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline

Participants will be asked how many days in the past 30 days they used a variety of substances, including alcohol. This self report question format is widely used to assess substance use (e.g., the GPRA from CSAT; SAMHSA, 2010).

Change in Self-Efficacy Across Time

时间窗: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline

Drug Avoidance Self-Efficacy Scale (DASES). The DASES (Martin et al., 1995) assesses one's current self-efficacy to resist drug use in hypothetical high-risk situations. The scale contains 16 items, and responses are rated on a 7-point scale ranging from "certainly yes" to "certainly no."

Change in Motivation to Change Across Time

时间窗: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline

The 32-item University of Rhode Island Change Assessment Questionnaire (URICA; McConnaughy et al., 1983, 1989) will be used to measure motivation to change. It has four 8-item scales (Precontemplation, Contemplation, Action, and Maintenance) that can be combined to create a single Readiness to Change score (C + A + M - PC = Readiness). Participants rate each item 1=Strongly Disagree to 5=Strongly Agree. This scale has good reliability and validity with adolescents (Greenstein et al., 1999).

Change on the Adolescent Relapse Coping Questionnaire (ARCQ) Across Time

时间窗: Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline

The ARCQ (Myers et al., 2006) assesses "temptation coping responses among adolescents." It begins with a short assessment of appraisal (5 items total) of a situation where peers are drinking and using, followed by 28 items rated between 1 = Definitely would not do or think, through 7 = Definitely would do or think. These 28 items comprise three subscales: Cognitive and behavioral problem solving (e.g., Let your feelings out somehow; alpha = .82); Self-critical thinking (e.g., Criticize or lecture yourself; alpha = .80); and Abstinence-focused coping (e.g., Leave or avoid the situation; alpha = .78).

次要结局

  • Counselor Satisfaction(3 months post baseline)
  • Change in Therapeutic Alliance Across Time(Baseline, 1 month post baseline, 3 months post baseline, 6 months post baseline)
  • Client Satisfaction(3 months post baseline)
  • Change in Client Engagement/Attendance Across time(1 month post baseline and 6 months post baseline)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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