Adolescent Substance Abuse: Progressive Treatment

描述（由申请人提供）：项目摘要：在过去的二十年中，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反应的异质性。该领域面临的主要挑战包括了解这些不同的反应轨迹，并制定策略来调整治疗方法，以提高对标准干预措施没有反应的人的有效性。迫切需要进行这种研究，以便向治疗服务提供者提供最佳护理战略。治疗服务研究工作的一个重要进展是，标准化干预措施所固有的“一刀切”的观点越来越少，人们呼吁制定适应性干预措施，将治疗算法纳入其中，以帮助临床决策。序贯多重分配随机试验（SMART）概述了一个过程，其中一个单独的研究中的一系列随机化被用来创建一个最佳的适应性干预。我们提出了两项研究，以检查八个潜在的适应性治疗策略的有效性，使用SMART设计。研究1的目标是双重的（1）检查用于定义早期治疗反应的两组不同标准（禁欲与最小使用）中的哪一组是后续治疗决策的最佳指南，即，如何最好地确定对最低限度治疗干预的反应何时“足够好”，以使青少年在不冒重大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应答者和复发者有更好的结果：相同治疗的增强版或新治疗？受试者（n=80）将接受由MET/CBT 8组成的初始剂量治疗。完成后，将按顺序将受试者随机分配至两个治疗反应标准之一，如果需要，还将分配至两个阶梯式干预措施之一。将使用SMART方案框架检查治疗前至治疗后结局，以确定包括响应特定治疗结局的最佳适应性治疗策略的特定临床组成部分。研究2是研究1中确定的最佳适应策略与标准MET/CBT 12组干预的有效性的初步（n=60）测试，并在治疗后3个月和6个月进行随访评估。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，以确定当接受MET/CBT 8初始疗程的青少年表现出初始治疗反应，坚持使用药物，或表现出初始治疗反应后复发时，如何最好地进行治疗。这种类型的“实用”临床试验开始了解决传统治疗疗效研究与临床实践中出现的关键问题之间的关键差距的漫长过程，例如确定青少年何时接受了足够的治疗，如何在最初的治疗努力无效时继续进行，以及如何最好地解决复发。研究2还将审查变化机制。

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.