Adaptive Treatment for At-Risk Family Caregivers

描述（由申请人提供）：拟议的研究将为痴呆症患者的家庭照顾者制定适应性治疗方案进行初步步骤。适应性治疗将照顾者的需求与适当的“量身定制”干预相匹配，使用操作治疗分配规则。适应性方法代表了一种新的治疗方法，它可以改善治疗照顾者压力和其他心理健康问题的结果，这些问题具有多个相互不高度相关的风险因素。25年的研究结果表明，家庭护理最好被概念化为一个多方面的系统，其中压力源彼此之间具有低到中等的相关性。换句话说，一个压力源（例如，行为问题）的存在或该压力源的治疗目标并不一定影响照顾者的其他压力源（例如，家庭冲突）和/或心理健康结果（例如，抑郁症状）。尽管有这些知识，以前的照顾者治疗模式采取了固定的，“一刀切”的方法，以相同的强度和剂量为所有参与者提供相同的治疗，而不考虑照顾者的风险和保护因素，也不考虑其他可能影响结果的潜在压力源。与固定疗法相比，适应性疗法只在参与者表现出需要特定治疗成分时才对其进行治疗。拟议的治疗发展研究将分两个阶段进行。第一阶段将侧重于制定治疗分配规则。30名护理人员将完成一套多维评估，其中包含与治疗模块相关的风险和保护因素的措施，然后将与一名训练有素的临床医生进行深入讨论，以阐明评估结果。将通过检查标准化工具的风险发现与护理人员的风险和需求报告之间的一致性和差异来制定治疗分配规则。第二阶段将在一项试点研究中应用第一阶段制定的治疗分配规则，该研究将在照顾患有痴呆症的家庭成员的30名主要护理人员的样本中实施和评估适应性治疗。结果将根据护理者对治疗的接受度和满意度，针对目标危险因素的模块效果的特异性，以及通过比较第一阶段和第二阶段参与者的近端和远端结果来评估。这些数据将提供适应性方法的可接受性和特异性的证据，以及可用于计划大规模试验的治疗效应大小的信息。

DESCRIPTION (provided by applicant): The proposed study will conduct preliminary steps for the development of an adaptive treatment protocol for family caregivers of people with dementia. An adaptive treatment matches caregivers' needs to an appropriate "tailor-made" intervention, using operational treatment assignment rules. The adaptive approach represents a new treatment methodology, which may improve outcomes for treating caregiver stress and other mental health problems that have multiple risk factors that are not highly correlated with one another. Findings from 25 years of research suggest that family caregiving can best be conceptualized as a multi-faceted system with stressors having low to moderate correlations with one another. In other words, the presence of one stressor (e.g., behavior problems) or the targeting of that stressor for treatment does not necessarily affect the caregivers' other stressors (e.g., family conflict) and/or mental health outcomes (e.g., depressive symptoms). Despite this knowledge, prior caregiver treatment models have taken a fixed, "one size fits all" approach, providing the same treatment to all participants at the same intensity and dosage regardless of caregivers' constellation of risk and protective factors and without consideration of other potential stressors that could affect outcomes. Contrasted to a fixed approach, the adaptive regimen treats participants only when they demonstrate the need for a particular treatment component. The proposed treatment development study will proceed in two phases. Phase 1 will focus on the development of treatment assignment rules. Thirty caregivers will complete a multidimensional assessment battery that contains measures of risk and protective factors related to treatment modules, and then will participant in an in-depth discussion with a trained clinician to clarify the findings of the assessment. Treatment assignment rules will be developed by examining consistencies and discrepancies between the findings of risk from standardized instruments and caregivers' reports of risk and need. Phase 2 will apply the treatment assignment rules developed in Phase 1 in a pilot study that implements and evaluates the adaptive treatment on a sample of 30 primary caregivers caring for a family member with a dementing illness. Outcomes will be assessed in terms of caregivers' acceptance and satisfaction with treatment, the specificity of effects of modules for targeted risk factors, and by comparing proximal and distal outcomes between Phase 1 and Phase 2 participants. These data will provide evidence of the acceptability and specificity of the adaptive approach as well as information about treatment effect size that could be used in planning a large-scale trial.