Integrating AAT into TF-CBT for Maltreated Youth: A Randomized Feasibility Trial

将 AAT 纳入针对受虐待青少年的 TF-CBT：一项随机可行性试验

• 批准号: 9322640
• 负责人: Brian J Allen
• 金额: $ 23.3万
• 依托单位: PENNSYLVANIA STATE UNIV HERSHEY MED CTR
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-05-01 至 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9322640
• 关键词: Age; Animals; Anti-Anxiety Agents; Anxiety; Appointments and Schedules; Behavioral Symptoms; Blinded; Canis familiaris; Caregivers; Child; Child Abuse; Child Abuse and Neglect; Clinical Trials; Cognitive Therapy; Data; Development; Electrocardiogram; Elements; Emotions; Event; Evidence based treatment; Failure; Feasibility Studies; Frequencies; Goals; Hydrocortisone; Intervention; Intervention Trial; Measures; Mediating; Mental Depression; Mental Health; Methodology; Outcome; Participant; Problem behavior; Procedures; Process; Protocols documentation; Publications; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Reporting; Research; Research Assistant; Rest; Review Literature; Salivary; Services; Sinus Arrhythmia; Stress; Surveys; Symptoms; Therapeutic; Trauma; Treatment Effectiveness; Treatment outcome; Youth; animal-assisted therapy; behavioral response; design; emotion regulation; emotional symptom; experience; improved; indexing; innovation; maltreated children; post-traumatic stress; public health relevance; respiratory; retention rate; satisfaction; stress reactivity; symptomatology; therapeutic development

Abstract The eventual goal of this line of research is to determine whether, and through what mechanisms, Animal- Assisted Therapy (AAT) is beneficial for the treatment of maltreated youth. The current project is a feasibility study to determine if larger clinical trials are warranted. The specific aims of the current study are (1) to examine whether the integration of AAT into standard Trauma-Focused Cognitive-Behavioral Therapy (TF- CBT) enhances treatment effectiveness, (2) to evaluate the tolerability and feasibility of AAT when integrated into TF-CBT, and (3) to evaluate hypothesized mediational processes that may explain observed positive effects for the integration of AAT. Maltreated youth may display myriad emotional and behavioral symptoms; prominent among these is posttraumatic stress (PTS). TF-CBT is a well-established evidence-based treatment for PTS and other symptoms subsequent to child maltreatment and, therefore, is a suitable intervention for this trial. Sixty (60) maltreated youth (ages 6-17) displaying elevated PTS will be assigned to receive TF-CBT or TF-CBT+AAT using a blocked randomization procedure. The TF-CBT protocol is the standard 12 90-minute sessions typically used in research trials. Youth in the TF-CBT+AAT condition will receive the standard protocol with a certified service dog present in the room for each session and the youth will be allowed to interact with the dog during session. A pre-post design will be used to ascertain whether the addition of AAT prompts greater PTS reduction as well as greater improvements in other outcomes, including internalizing symptoms, externalizing symptoms, and emotion regulation. Outcome metrics include caregiver and youth- reported objective measures, and respiratory sinus arrhythmia (RSA) assessed via an electrocardiogram (ECG) during both a resting and stress reactivity paradigm. Feasibility metrics assessed include treatment satisfaction, ability to implement the TF-CBT components with a dog in the room, treatment disrupting events attributable to the dogs, and whether the dogs experienced significant stress as a result of their participation. Stress experienced by the dog will be determined through RSA, salivary cortisol, and behavioral responses. Two prominent hypotheses regarding the mechanism of effect for AAT will be examined. First, therapeutic rapport will be assessed at multiple increments to determine whether the presence of the dog improved the quality or efficiency of development of rapport. Second, RSA will be recorded for the youth during treatment sessions to determine if the presence of the dog yielded a lower intensity of stress during the sessions. Both therapeutic rapport and level of in-session stress will be examined as mediating variables to determine whether either explained enhanced treatment outcomes. To improve the methodological rigor of the study, data will be collected by research assistants blinded to the youth's treatment condition and the same clinicians will implement both treatment conditions, thereby eliminating clinician-specific effects on outcomes.

抽象的 这项研究线的最终目标是确定是否以及通过哪些机制，动物 - 辅助治疗（AAT）有益于治疗虐待青年。当前项目是可行性 研究以确定是否有必要进行较大的临床试验。当前研究的具体目的是（1） 检查AAT是否将AAT整合到标准以创伤为重点的认知行为疗法中（TF- CBT）提高了治疗效率，（2）在整合时评估AAT的耐受性和可行性 进入TF-CBT，（3）评估假设的中介过程，这些过程可能解释了观察到的阳性 AAT集成的效果。受虐待的青年可能表现出无数的情感和行为症状； 其中突出的是创伤后压力（PTS）。 TF-CBT是一种良好的循证治疗 对于儿童虐待后的PT和其他症状，因此是适当的干预措施 审判。将分配六十（60）个虐待青年（6-17岁），显示升高的PT将被分配接受TF-CBT或 TF-CBT+AAT使用阻塞的随机化过程。 TF-CBT协议是标准12 90分钟 研究试验通常使用的会议。 TF-CBT+AAT条件中的年轻人将获得标准 每个会议中都有一个经过认证的服务犬的协议，将允许年轻人 会议期间与狗互动。将使用前设计的设计来确定是否添加了AAT 提示更大的PT减少以及其他结果的改进，包括内部化 症状，外在症状和情绪调节。结果指标包括护理人员和青年 - 报告的客观措施和通过心电图评估的呼吸窦性心律不齐（RSA） （ECG）在休息和应力反应性范式中。评估的可行性指标包括治疗 满意度，在房间内用狗实施TF-CBT组件的能力，治疗破坏事件 归因于狗，以及狗是否由于参与而产生重大压力。 狗所经历的压力将通过RSA，唾液皮质醇和行为反应确定。 将研究有关AAT效应机制的两个主要假设。首先，治疗性 将以多种增量评估融洽的关系，以确定狗的存在是否改善 融洽的质量或效率。其次，将在治疗期间为年轻人记录RSA 确定狗的存在是否产生较低的应力强度。两个都 治疗融洽的融洽关系和课内压力水平将被视为中介变量，以确定是否是否 要么解释了增强的治疗结果。为了改善研究的严格性，数据将是 由研究助理收集的，对年轻人的治疗状况视而不见，同一临床医生将 实施这两种治疗条件，从而消除了临床医生对结局的特定影响。