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.

摘要 这一系列研究的最终目标是确定动物是否以及通过何种机制- 辅助治疗（AAT）是有益的虐待青少年的治疗。目前的项目是可行性的 研究以确定是否需要进行更大规模的临床试验。本研究的具体目标是：（1） 检查AAT是否整合到标准的创伤集中认知行为治疗（TF- CBT）提高治疗效果，（2）评估AAT整合时的耐受性和可行性 TF-CBT，和（3）评估假设的中介过程，可以解释观察到的阳性 对AAT整合的影响。受虐待的青少年可能会表现出无数的情绪和行为症状; 其中最突出的是创伤后应激障碍。TF-CBT是一种成熟的循证治疗方法 对于PTS和儿童虐待后的其他症状，因此是一种合适的干预措施。 审判60名PTS升高的受虐待青少年（6-17岁）将被分配接受TF-CBT或 采用区组随机化程序的TF-CBT+AAT。TF-CBT协议是标准的12 90分钟 通常用于研究试验的会话。TF-CBT+AAT条件下的青少年将获得标准 协议与认证的服务犬目前在房间里的每一个会议和青年将被允许 在会议期间与狗互动。我们会采用事前事后设计，以确定增设学能测验 促使更多地减少临时技术秘书处，并在其他成果方面取得更大的改进， 症状、外化症状和情绪调节。结果指标包括照顾者和青年- 报告了客观测量，并通过心电图评估了呼吸性窦性心律失常（RSA） (ECG)在静息和应激反应模式下。评估的可行性指标包括治疗 满意度，在房间内有狗的情况下实施TF-CBT组件的能力，治疗中断事件 结果表明，狗的参与，以及狗是否经历了显着的压力，作为他们的参与的结果。 将通过RSA、唾液皮质醇和行为反应来确定犬所经历的压力。 两个突出的假设，关于AAT的作用机制将进行检查。第一，治疗性 将以多个增量评估融洽关系，以确定犬的存在是否改善了 融洽关系发展的质量或效率。第二，RSA将在治疗期间为青少年记录 以确定狗的存在是否在会议期间产生较低强度的压力。两 治疗融洽和会话压力水平将作为中介变量进行检查，以确定是否 都能解释治疗效果的增强为了提高研究方法的严谨性，数据将 由研究助理收集，对年轻人的治疗状况不知情，同样的临床医生将 实施这两种治疗条件，从而消除临床医生对结果的特定影响。