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、简短、涉及家庭的治疗方法，可以灵活地用于正在进行的酒精治疗环境，以促进循证治疗的传播。在这项资助中开发和测试的治疗方法，“B-FIT”（简短的家庭参与治疗），建立在PI早期niaaa支持的酒精行为夫妻治疗（ABCT）变化机制的疗效试验和研究的基础上，并被设计为社区药物滥用治疗的补充（TAU）。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依从性和戒断的激励，提高患者的治疗依从性和结果。研究目标被仔细排序，以开发B-FIT方法，并通过一套严格的保真度分析、小规模临床试验和潜在活性成分、介质和治疗反应调节因子的前瞻性测试来判断其优点。具体目标是：(1)修改ABCT，使其(a)适合任何有关家庭成员，(b)更短，(c)侧重于关键的改变机制，(d)适合作为正在进行的酒精治疗方案的一部分使用，以及(e)通过纳入行为合同程序而更有效；(2)开展B-FIT的小规模临床试验；(3)确定更大规模RCT的材料。为了实现研究目标，将完成1A期连续队列治疗开发方法，然后进行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，B-FIT将在RCT中进行测试，以确定可行性和初步疗效。该计划包括六个阶段：(1)与服务提供者、患者和患者的相关家属（cfm）进行焦点小组讨论，以获得对B-FIT内容和材料的反馈；(2)根据焦点小组的反馈修改B-FIT协议；(3)对临床医生进行B-FIT方案培训，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将在治疗后进行汇报，以评估B-FIT干预。(4)根据试点研究的反馈进一步修改B-FIT材料，并通过第二组焦点小组就B-FIT书面材料的可读性、相关性和易用性获得反馈。(5)对临床医生进行B-FIT治疗的结构化教学和体验式培训。(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的可行性及其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；(c)评估治疗师的忠诚；(d)测量治疗中假设的有效成分；(e)进行初始调节因子分析。与第1-5阶段同时，所有措施和研究程序将最终确定。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.