A Clinical Trial for Treatment-Resistant Subtypes of Self Injury

自伤难治性亚型的临床试验

• 批准号: 10407635
• 负责人: LOUIS P. HAGOPIAN
• 金额: $ 33.67万
• 依托单位: HUGO W. MOSER RES INST KENNEDY KRIEGER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-27 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10407635
• 关键词: Address; Attention; Behavior; Behavior Therapy; Biological; Blindness; Clinical; Clinical Treatment; Clinical Trials; Combined Modality Therapy; Crossover Design; Data; Data Analyses; Data Set; Devices; Effectiveness; Equipment; Impairment; Individual; Injury; Inpatients; Intellectual functioning disability; Intervention; Laws; Literature; Methods; National Institute of Child Health and Human Development; Patient Admission; Persons; Phase; Positioning Attribute; Procedures; Psychological reinforcement; Randomized; Reinforcement Schedule; Research; Research Support; Resistance; Self-Help Devices; Self-Injurious Behavior; Self-control as a personality trait; Social Reinforcement; Source; Standardization; Stimulus; Toy; Training; design; effective intervention; experience; insight; loss of function; novel; pilot test; programs; reinforcer; restraint; skills; standard of care; success

Project Summary/Abstract At least one quarter of the 18 million persons in the US with intellectual and developmental disabilities engage in self-injurious behavior (SIB), which can result in injuries, disfigurement, and loss of function (e.g., blindness). In most cases, SIB is maintained by social reinforcement (e.g., attention). SIB that persists in the absence of social reinforcement has been referred to as automatically reinforced SIB (ASIB), based on the supposition that the behavior itself produces some type of biological reinforcement. The current standard of care approach to treatment for ASIB includes two phases: a Pre-Treatment Assessment (a Competing Stimulus Assessment to identify stimuli associated with reductions in ASIB), followed by treatment where competing stimuli are delivered on a noncontingent reinforcement (NCR) schedule. Our NICHD- supported research to date has identified subtypes of ASIB that vary greatly in terms of their responsiveness to these treatments. Subtypes are based on results of standardized assessment conditions: Subtype 1 varies inversely with the level of stimulation across conditions; Subtype 2 is invariant; and Subtype 3 is characterized by self-restraint, a self-limiting behavior that occurs to avoid ASIB, but also impairs adaptive functioning. Treatments using NCR with competing stimuli alone are effective in over 82% of cases with Subtype 1, but in only 7% of cases with Subtype 2 or 3, necessitating restraint or protective equipment to sufficiently reduce ASIB. The identification of subtypes has revealed the urgent need for more effective interventions for the treatment-resistant subtypes. Fortunately, our research (R01 HD076653) has also led to several recent discoveries that provide the conceptual and empirical basis for a new Intensified Approach to treatment targeting the most treatment-resistant subtypes (Subtype 2 and 3 ASIB). The proposed treatment approach is based on the same principles as the current Standard of Care Approach (Matching Law and reinforcer competition), but employs novel methods to more effectively compete with reinforcement maintaining Subtype 2 and 3 ASIB, and to address self-restraint for Subtype 3. The proposed Intensified Approach to treatment includes three phases: 1) Pre-Treatment Assessments will identify competing stimuli, tasks, and self-control devices that reduce ASIB; 2) Intensive Training to strengthen skills needed to fully access available reinforcement, and replace debilitating self-restraint; and 3) Combination Treatment using NCR to deliver, and differential reinforcement for engagement with: multiple competing stimuli, competing tasks, and alternative self-control devices (for Subtype 3). Combination Treatment is designed to greatly increase the amount and vary the sources of alternative reinforcement. Aim 1 is to identify and establish competing stimuli, competing tasks, and self-control devices (Subtype 3 ASIB). Aim 2 is to employ a randomized crossover design to demonstrate the effectiveness of Combination Treatment (developed using the Intensified Approach), relative to NCR with competing stimuli alone (developed using the current Standard of Care Approach) for reducing ASIB and self-restraint.

项目总结/摘要 在美国，1800万智力和发育障碍者中至少有四分之一的人 在自我伤害行为（SIB），这可能会导致伤害，毁容，和功能丧失（例如，失明）。 在大多数情况下，SIB是通过社会强化来维持的（例如，注意）。在没有的情况下持续存在的SIB 社会强化被称为自动强化SIB（ASIB），基于这样的假设， 这种行为本身会产生某种生物强化。目前的标准治疗方法 ASIB的治疗包括两个阶段：治疗前评估（竞争刺激评估 以确定与ASIB降低相关的刺激），然后进行治疗，其中竞争性刺激 非特遣队增援（NCR）计划。到目前为止，我们的NICHD支持的研究 ASIB的亚型在对这些治疗的反应性方面差异很大。亚型 根据标准化评估条件的结果：亚型1与水平呈反比变化， 亚型2是不变的;亚型3的特征是自我约束， 为避免ASIB而发生的自我限制行为，但也会损害适应功能。使用NCR的治疗 与竞争性刺激单独使用在超过82%的亚型1病例中有效，但在只有7%的亚型1病例中有效。 亚型2或3，需要约束或防护设备以充分减少ASIB。的识别 亚型的研究表明，迫切需要对耐药亚型进行更有效的干预。 幸运的是，我们的研究（R 01 HD 076653）也导致了一些最近的发现， 新的强化治疗方法的概念和经验基础， 治疗耐药亚型（亚型2和3 ASIB）。所提出的处理方法基于相同的 原则作为目前的标准护理方法（匹配法和竞争），但采用 新的方法，以更有效地竞争与加强维持亚型2和3 ASIB， 解决亚型3的自我约束问题。拟议的强化治疗方法包括三个阶段： 治疗前评估将确定减少ASIB的竞争刺激，任务和自我控制设备; 2） 强化培训，以加强所需的技能，以充分获得可用的增援，并取代削弱 自我约束;和3）使用NCR提供的组合治疗， 参与：多种竞争刺激，竞争任务和替代自我控制设备（对于亚型 3）。联合治疗的目的是大大增加量和不同的来源替代 加固.目标1是识别和建立竞争刺激、竞争任务和自我控制装置 （亚型3 ASIB）。目的2是采用随机交叉设计来证明 联合治疗（使用强化方法开发），相对于具有竞争性刺激的NCR 单独使用（使用当前的标准治疗方法开发）用于减少ASIB和自我约束。