Developing a Brief Family-Involved Treatment for Alcohol Use Disorders

描述（由申请人提供）：这项治疗开发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，可以在正在进行的酒精治疗环境中灵活使用，以促进循证治疗的传播。在此资助中开发和测试的治疗“B-FIT”（简短的家庭参与治疗）建立在PI早期NIAAA支持的疗效试验和酒精行为夫妇治疗（ABCT）变化机制的研究基础上，并被设计为基于社区的药物滥用治疗的附加物。B-FIT通过改善家庭功能和增加家庭提供的治疗依从性和禁欲激励措施，利用家庭参与来提高患者的治疗依从性和结局。研究目标经过仔细排序，以开发B-FIT方法，并通过一系列严格的保真度分析、小规模临床试验以及对潜在活性成分、介体和治疗反应调节剂的前瞻性测试来判断其优点。具体目标是：（1）修改ABCT，使其（a）适合任何相关家庭成员，（B）更短，（c）专注于关键的变化机制，（d）适合作为正在进行的酒精治疗计划的一部分，（e）通过纳入行为契约程序更有效;（2）进行B-FIT的小规模临床试验;（3）完成大规模RCT的材料。为了实现研究目的，将完成1A期连续队列治疗开发方法，然后是1B期小型随机临床试验（RCT）。在1A阶段，将确定B-FIT中的关键干预措施，并将其纳入治疗手册的初步版本。然后，在1B阶段，将在RCT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）进行焦点小组讨论，以获得有关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）对临床医生进行B-FIT方案培训，然后对六名患者及其CFM进行试点测试。每位临床医生、患者和CFM将在治疗后接受汇报，以评估B-FIT干预。(4)进一步修改B-FIT材料，以响应试点研究的反馈，以及第二组焦点小组，用于获得B-FIT书面材料在可读性、相关性和易用性方面的反馈。(5)为临床医生提供关于B-FIT治疗的结构化教学和体验培训。(6)将对60名ASAP患者及其CFM进行TAU与B-FIT + TAU的小规模随机临床试验，以（a）测试B-FIT的可行性和对患者治疗保留的影响，（B）获得饮酒、CFM和家庭功能前后变化的效应量估计值;（c）评估治疗师忠诚度;（d）测量治疗中假设的活性成分;及（e）进行初步缓和剂分析。在第1-5阶段的同时，将完成所有措施和研究程序。作为临床试验的一部分，将收集3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.