Adolescent Substance Abuse: Progressive Treatment

描述(由申请人提供)：项目摘要：过去20年来，对有效的青少年药物滥用干预措施的研究一直表明，对治疗的反应是不同的。该领域的关键挑战包括了解这些不同的反应轨迹，并制定战略以调整治疗方法，以提高对标准干预无效的人的有效性。这类研究对于让治疗服务提供者了解最佳护理策略是非常必要的。治疗服务研究工作的一个重要进展是，标准化干预措施中固有的“一刀切”观点日益减少，并呼吁开发纳入治疗算法的适应性干预措施，以帮助临床决策。序贯多重分配随机试验(SMART)概述了使用个体研究中的一系列随机化来创建最佳适应性干预的过程。我们提出了两项研究，以检验使用SMART设计的八种潜在适应性治疗策略的有效性。研究1的目标有两个：(1)审查确定早期治疗反应(禁欲和最低限度使用)的两套不同标准中哪一种是随后治疗决定的最佳指南，即如何最好地确定何时对最低限度的治疗干预的反应“足够好”，使青少年能够在不冒显著复发风险的情况下退出治疗。(2)确定两种阶梯式适应性干预措施中哪一种对治疗无效者和复发者有更好的结果：是相同治疗的强化版还是新的治疗？参与者(n=80)将接受由MET/CBT8组成的初始剂量的治疗。完成后，参与者将按顺序被随机分配到两个治疗反应标准中的一个，如果需要，还将被分配到两个分步干预中的一个。将使用SMART方案框架检查治疗前到治疗后的结果，以确定构成针对特定治疗结果的最佳适应性治疗策略的具体临床组成部分。研究2是对研究1中确定的最佳适应策略的有效性与标准的MET/CBT 12组干预的有效性的试点(n=60)测试，并在治疗后3个月和6个月进行跟踪评估。相关性：这项研究将为治疗机构提供一套系统的最佳决策规则，说明当接受MET/CBT8初始疗程的青少年表现出初步治疗反应、坚持使用药物或表现出最初的治疗反应随后复发时，如何最好地继续进行。这种类型的“实用”临床试验开始了一个拖延已久的进程，即解决传统治疗效果研究与临床实践中出现的关键问题之间的关键差距，如确定青少年何时接受了足够的治疗，当初步治疗努力无效时如何继续进行，以及如何最好地解决复发问题。研究2还将审查变化的机制。

DESCRIPTION (provided by applicant): Project Summary: Research on efficacious adolescent substance abuse interventions over the past two decades has consistently demonstrated heterogeneity of response to treatment. Key challenges for the .field include understanding these various response trajectories and establishing strategies to adapt treatments to enhance their effectiveness for those who are not responsive to standard interventions. Such research is critically needed to inform treatment services providers on optimal care strategies. An important advance in treatment services research efforts is the increasing movement away from a "one-size-fits-all" perspective inherent in standardized interventions and a call for the development of adaptive interventions that incorporate treatment algorithms to aid clinical decision-making. The Sequential Multiple Assignment Randomized Trial (SMART) outlines a process whereby a series of randomizations within an individual study is used to create an optimal adaptive intervention. We propose two studies to examine the efficacy of eight potential adaptive treatment strategies using the SMART design. Study 1 goals are twofold (1) to examine which of two distinct sets of criteria for defining early treatment response (abstinence vs. minimal use) is the best guide for subsequent treatment decisions, i.e., how best to determine when response to a minimal treatment intervention is "good enough" for an adolescent to step out of treatment without risking a significant relapse. (2) to determine which of two stepped adaptive interventions result in better outcomes for treatment non-responders and relapsers: an enhanced version of the same treatment or a new treatment? Participants (n=80) will receive an initial dose of treatment consisting of MET/CBT8. At completion, participants will be randomly assigned, in sequential steps, to one of two treatment response criteria and, if needed, one of two stepped interventions. Pre- to post-treatment outcomes will be examined using the SMART protocol framework to identify the specific clinical components comprising the optimal adaptive treatment strategy in response to a particular treatment outcome. Study 2 is a pilot (n=60) test of the efficacy of the optimal adaptive strategy identified in Study 1 vs. a standard MET/CBT 12 group intervention, with follow up assessments at 3 and 6 months post-treatment. Relevance: This research will provide a systematic set of optimal decision rules for treatment agencies on how best to proceed when adolescents receiving an initial course of MET/CBT8 show initial treatment response, persist in their substance use, or demonstrate an initial treatment response followed by later relapse. This type of "practical" clinical trial begins the long overdue process of addressing critical gaps between traditional treatment efficacy research and key questions that emerge in clinical practice such as determining when adolescents have received sufficient treatment, how to proceed when initial treatment efforts are not effective, and how best to address relapse. Mechanisms of change will also be examined in Study 2.