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。适应性治疗使用可操作的治疗分配规则，将照顾者的需求与适当的“量身定制”干预相匹配。适应性方法代表了一种新的治疗方法，它可能会改善治疗照顾者压力和其他心理健康问题的结果，这些问题具有多个风险因素，彼此之间的相关性不高。25年的研究结果表明，家庭照料最好被概念化为一个多方面的系统，压力因素之间具有低到中等的相关性。换句话说，存在一种应激源(例如，行为问题)或针对该应激源进行治疗并不一定会影响照顾者的其他应激源(例如，家庭冲突)和/或心理健康结果(例如，抑郁症状)。尽管如此，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向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，也没有考虑其他可能影响结果的潜在应激源。与固定方法相比，适应性方案仅在参与者证明需要特定治疗组件时才进行治疗。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名护理者将完成一组多维评估，其中包含与治疗模块相关的风险和保护因素的测量，然后将参与与训练有素的临床医生的深入讨论，以澄清评估的结果。治疗分配规则将通过审查标准化工具的风险调查结果与照顾者关于风险和需要的报告之间的一致性和差异来制定。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，该研究在照顾患有痴呆症的家庭成员的30名主要照顾者的样本上实施和评估适应性治疗。结果将根据照顾者对治疗的接受度和满意度、针对目标风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之间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，以及可用于规划大规模试验的治疗效果大小的信息。

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.