Understanding the Mechanisms of Change and Optimal Parameters in Conversation Treatment for Aphasia

了解失语症对话治疗的变化机制和最佳参数

• 批准号: 10376257
• 负责人: GAYLE L DEDE
• 金额: $ 66.42万
• 依托单位: BOSTON UNIVERSITY (CHARLES RIVER CAMPUS)
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10376257
• 关键词: Address; Affect; Aftercare; American; Americas; Aphasia; Behavior; Behavioral; Caring; Clinical; Clinical Trials; Communication; Communication Barriers; Communication impairment; Control Groups; Cues; Data; Enrollment; Ensure; Event; Future; Goals; Health; Health Services Accessibility; Hobbies; Impairment; Individual; Intervention; Knowledge; Language; Language Disorders; Lead; Learning; Life; Linguistics; Logic; Maps; Measurable; Measures; Medical Care Costs; Modeling; Names; Outcome; Outcome Measure; Participant; Pathway interactions; Patient Outcomes Assessments; Patient Self-Report; Performance; Persons; Phase; Psychosocial Assessment and Care; Psychosocial Factor; Randomized; Randomized Controlled Clinical Trials; Research; Resources; Risk; Sampling; Service delivery model; Severities; Site; Social isolation; Speech Pathologist; Standardization; Testing; Treatment Efficacy; Treatment outcome; Variant; Work; base; cost effective; dosage; efficacy evaluation; efficacy testing; evidence base; improved; member; mortality; multimodality; primary outcome; programs; secondary outcome; skills; social relationships; treatment effect; treatment group; treatment research

Aphasia is a language disorder that affects approximately two million Americans. The communication barriers associated with aphasia limit the ability to return to work and hobbies, worsen social relationships, and lead to social isolation. Social isolation is correlated with many negative health outcomes, including mortality. As a result, the consequences of aphasia can be wide reaching and severe. Group treatment has the potential to improve communication and reduce social isolation, while also reducing medical costs. However, this treatment format lacks a strong evidence base. This research uses a hypothesis-driven approach to test the efficacy of conversation treatment and develop and refine a mechanistic pathway of how conversation treatment leads to behavioral changes in communication ability. We will systematically explore whether the effects of treatment differ as a result of number of participants (large group or dyad), group composition (heterogenous versus homogenous profiles of aphasia), and severity of aphasia. The study will enroll a total of 168 participants with aphasia across three sites. In cycle one, 72 participants will be randomly assigned to one of three conditions: dyad treatment, traditional group treatment or delayed control group. In cycles two and three, 48 participants with severe aphasia and 48 participants with mild-moderate aphasia will be randomly assigned to either large group or dyad conditions. In all cycles, treatment will occur for 60 minutes, twice per week for 10 weeks. During treatment sessions, a speech pathologist will facilitate discourse on a focused set of salient topics, such as current events, using individualized, linguistic and multimodal cueing hierarchies. The primary outcome measure is a functional measure of communication (Aphasia Communication Outcome Measure, ACOM; Hula et al., 2015). Secondary outcome measures will include standardized tests and patient reported outcome measures, and examine linguistic and functional communication abilities. All participants will be assessed pre-, post-, 4 weeks post- and 12 weeks post-treatment. The proposed research will address the following specific aims. Specific Aim 1 is to examine efficacy of conversation treatment delivered in dyads and large groups compared to a delayed-treatment control group. Specific Aim 2 is to determine optimal parameters for conversation treatment by testing whether the treatment effects differ as a function of aphasia severity (2A) or group composition (2B). Specific Aim 3 will test a hypothesized model of the pathway by which conversation treatment effects behavioral change. The results will provide further efficacy for conversation treatment and inform about the optimal parameters and outcomes of this intervention. This work takes a vital first step towards elucidating the mechanisms of change in conversation group treatment, with a long-term goal of ensuring access to cost-effective care for people with aphasia.

失语症是一种语言障碍，影响大约200万美国人。与失语症相关的沟通障碍限制了重返工作和爱好的能力，恶化了社会关系，并导致社会孤立。社会孤立与许多负面健康结果相关，包括死亡率。因此，失语症的后果可能是广泛和严重的。集体治疗有可能改善沟通，减少社会孤立，同时也降低医疗费用。然而，这种治疗方式缺乏强有力的证据基础。本研究采用假设驱动的方法来测试会话治疗的有效性，并开发和完善会话治疗如何导致沟通能力的行为变化的机制路径。我们将系统地探讨治疗效果是否因受试者人数（大组或二对）、组组成（失语症的异质性与同质性）和失语症的严重程度而不同。该研究将在三个研究中心共招募168名失语症受试者。在第一个周期，72名参与者将被随机分配到三个条件之一：二分体治疗，传统组治疗或延迟对照组。在第二和第三个周期，48名严重失语症患者和48名轻中度失语症患者将被随机分配到大组或二分体条件下。在所有周期中，治疗将进行60分钟，每周两次，持续10周。在治疗过程中，言语病理学家将促进一组集中的突出主题，如时事，使用个性化，语言和多模态提示层次的话语。主要结果测量是沟通的功能测量（失语症沟通结果测量，ACOM; Hula等人，2015年）的报告。次要结局指标将包括标准化测试和患者报告的结局指标，并检查语言和功能沟通能力。将在治疗前、治疗后、治疗后4周和治疗后12周对所有受试者进行评估。拟议的研究将针对以下具体目标。具体目标1是检查疗效的会话治疗交付的二人组和大组相比，延迟治疗的对照组。具体目标2是通过测试治疗效果是否随失语症严重程度（2A）或组组成（2B）而不同来确定会话治疗的最佳参数。具体目标3将测试会话治疗影响行为改变的途径的假设模型。研究结果将为谈话治疗提供进一步的疗效，并为这种干预的最佳参数和结果提供信息。这项工作迈出了至关重要的第一步，阐明了会话组治疗的变化机制，其长期目标是确保失语症患者获得具有成本效益的护理。