Adolescent Substance Abuse: Progressive Treatment

项目概述：在过去的二十年中，对有效的青少年药物滥用干预的研究一直表明对治疗的反应存在异质性。该领域面临的主要挑战包括了解这些不同的反应轨迹，并制定适应治疗的策略，以提高对标准干预措施没有反应的患者的有效性。这种研究是迫切需要的，以告知治疗服务提供者的最佳护理策略。治疗服务研究工作的一项重要进展是，标准化干预措施中固有的“一刀切”观点正在逐渐消失，人们呼吁开发适应性干预措施，将治疗算法纳入其中，以帮助临床决策。顺序多重分配随机试验（SMART）概述了在个体研究中使用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来检验使用SMART设计的八种潜在适应性治疗策略的有效性。研究1的目标是双重的(1)检查定义早期治疗反应的两套不同标准（戒断与最小使用）中哪一套是后续治疗决策的最佳指导，即，如何最好地确定对最小治疗干预的反应何时“足够好”，可以让青少年退出治疗而不会冒着严重复发的风险。(2)确定两步适应性干预措施中哪一步对治疗无反应者和复发者有更好的结果：相同治疗的强化版本或新治疗？参与者（n=80）将接受由MET/CBT8组成的初始剂量治疗。完成后，参与者将按顺序随机分配到两种治疗反应标准中的一种，如果需要，两种干预措施中的一种。将使用SMART协议框架检查治疗前后的结果，以确定特定的临床成分，包括针对特定治疗结果的最佳适应性治疗策略。研究2是一项试验（n=60），对研究1中确定的最佳适应策略与标准MET/CBT 12组干预的疗效进行了测试，并在治疗后3个月和6个月进行了随访评估。相关性：本研究将为治疗机构提供一套系统的最佳决策规则，当青少年接受MET/CBT8初始疗程时，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，随后复发时，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，例如确定青少年何时接受了充分的治疗，当最初的治疗努力无效时如何进行，以及如何最好地解决复发问题。变化的机制也将在研究2中进行研究。

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.