Developing a Brief Family-Involved Treatment for Alcohol Use Disorders

描述(由申请人提供)：这项治疗发展研究的总体目标是开发一种有效的、简短的、家庭参与的治疗方法，可以在持续的酒精治疗环境中灵活使用，以促进循证治疗的传播。在这笔赠款中将开发和测试的治疗方法“B-Fit”(简要家庭参与治疗)，建立在PI早期由NIAAA支持的疗效试验和酒精行为夫妇疗法(ABCT)改变机制研究的基础上，并被设计为社区药物滥用照常治疗(TAU)的补充。B-Fit利用家庭参与，通过改善家庭功能和增加家庭提供的治疗坚持和禁欲激励，来提高患者的治疗依从性和结果。研究目标被仔细地排序，以开发B-Fit方法，并通过一套严格的保真度分析、小规模临床试验和对潜在的治疗反应的活性成分、介体和调节剂的前瞻性测试来判断其优点。具体目标是：(1)修改ABCT，以使其(A)适合任何相关的家庭成员，(B)更短，(C)专注于改变的关键机制，(D)适合用作正在进行的酒精治疗计划的一部分，以及(E)通过纳入行为合同程序而更有效；(2)进行B-Fit的小规模临床试验；以及(3)最终确定用于更大规模RCT的材料。为了实现研究目标，将完成1A阶段的连续队列治疗开发方法，然后是1B阶段的小型随机临床试验(RCT)。在第1A阶段，将确定B-Fit的关键干预措施，并将其纳入治疗手册初版。然后，在1B阶段，将在随机对照试验中测试B-Fit，以确定可行性和初步疗效。该项目包括六个阶段：(1)与服务提供者、患者和患者的相关家庭成员(CFM)组成焦点小组，以获得关于B-FIT内容和材料的反馈；(2)根据焦点小组的反馈修改B-FIT方案；(3)临床医生接受B-FIT方案的培训，然后对6名患者及其CFM进行试点测试。每位临床医生、患者和CFM将在治疗后听取汇报，以评估B-Fit干预。(4)根据试点研究的反馈意见对B-Fit材料进行进一步修改，以及用于在可读性、相关性和易用性方面获得对B-Fit书面材料的反馈的第二组重点小组。(5)对临床医生进行关于B-Fit治疗的结构化教学和经验性培训。(6)将对60名ASAP患者及其CFM进行一项TAU与B-Fit+TAU的小规模随机临床试验，以(A)测试B-Fit的可行性及其对患者治疗保留的影响，(B)获得治疗前饮酒、CFM和家庭功能变化的有效规模估计；(C)评估治疗师忠诚度；(D)测量治疗中假想的有效成分；以及(E)进行初步主持人分析。与第1-5阶段并行，将最后确定所有措施和研究程序。作为临床试验的一部分，将收集三个月的随访数据。

DESCRIPTION (provided by applicant): The overall aim of this treatment development study is to develop an efficacious, brief, family-involved treatment that can be used flexibly in on-goin alcohol treatment settings to advance the dissemination of evidence-based treatment. The treatment to be developed and tested in this grant, "B-FIT" (Brief Family- Involved Treatment), builds on the PI's earlier NIAAA-supported efficacy trials and studies of mechanisms of change in Alcohol Behavioral Couple Therapy (ABCT) and is designed as an add-on to community-based substance abuse treatment-as-usual (TAU). B-FIT uses family involvement to enhance patient treatment adherence and outcomes by improving family functioning and increasing family-provided incentives for treatment adherence and abstinence. Study aims are carefully sequenced to develop the B-FIT approach and to judge its merits through a rigorous set of fidelity analyses, a small-scale clinical trial, and prospective tests of potential active ingrediets, mediators, and moderators of treatment response. Specific aims are to: (1) modify ABCT to make it (a) appropriate for any concerned family member, (b) shorter, (c) focused on key mechanisms of change, (d) appropriate for use as part of an on-going alcohol treatment program, and (e) more efficacious by incorporating behavioral contracting procedures; (2) conduct a small-scale clinical trial of B-FIT; and (3) finalize materials for a larger-scale RCT. T accomplish study aims, a stage 1A successive cohort treatment development approach followed by a stage 1B small randomized clinical trial (RCT) will be completed. In the 1A stage, key interventions in B-FIT will be identified and integrated into the preliminary version of the treatment manual. Then, in the 1B stage B-FIT will be tested in an RCT to determine feasibility and preliminary efficacy. The project includes six phases: (1) focus groups with service providers, patients, and concerned family members (CFMs) of patients to obtain feedback about the B-FIT content and materials; (2) modification of the B-FIT protocol in response to the focus group feedback; (3) clinician training in the B-FIT protocol followed by pilot testing with six patients and their CFMs. Each clinician, patient and CFM will be debriefed after the treatment to assess the B-FIT intervention. (4) Further modifications to the B-FIT materials in response to feedback from the pilot study as well as a second set of focus groups used to obtain feedback on the B-FIT written materials in terms of readability, relevance, and ease of use. (5) Structured didactic and experiential training for clinicians on the B-FIT treatment. (6) A small-scale, randomized clinical trial of TAU versus B-FIT + TAU will be conducted with 60 ASAP patients and their CFMs to (a) test the feasibility of B-FIT and impact on patient treatment retention, (b) obtain effect size estimates for pre-post changes in drinking, CFM, and family functioning; (c) assess therapist fidelity; (d) measure hypothesized active ingredients in the treatment; and (e) conduct initial moderator analyses. In parallel with phases 1-5 all measures and study procedures will be finalized. Three month follow-up data will be collected as part of the clinical trial.