A RANDOMIZED CONTROLLED TRIAL OF PCIT-ED FOR PRESCHOOL DEPRESSION

描述(由申请人提供)：PCIT-ED治疗学龄前抑郁的随机对照试验来自几个独立研究小组的数据表明，DSM-IV抑郁障碍的发病可能早在学龄前阶段就发生了。稳定和特定的症状群，相关疾病的家族史，特征性变化 在压力下，皮质醇的反应性以及与学龄期抑郁症的同型连续性提供了 强烈支持学龄前抑郁症代表儿童后期障碍的一种早期发病形式这一原则。来自美国和欧洲的流行病学研究估计，学龄前抑郁症(PO-MDD)的患病率为1-2%，与学龄儿童的患病率相同。来自我们实验室的新数据表明，抑郁的学龄前儿童表现出与成人抑郁症相似的大脑功能活动变化。这些大脑变化在急性学龄前发作期间和后来的学龄期都被检测到，甚至在抑郁发作缓解后也是如此。这些发现综合起来强调了在学龄前阶段治疗MDD的必要性。然而，由于PO-MDD只是最近才被认识到，治疗方法的研究仍然未知。对于PO-MDD的有效治疗的需要超越了帮助受影响的学龄前儿童的重要目标，但也可能对这种慢性和慢性疾病的早期和潜在更有效的干预产生影响 复发性精神障碍。基于早期干预对几种学龄前障碍的大效应，开发了一种对PO-MDD的早期干预，即亲子互动治疗情绪发展(PCIT-ED)，并进行了初步测试。PCIT-ED是PCIT的扩展，PCIT是一种广为人知的、广泛使用和被证明有效的学龄前破坏性障碍治疗方法。为了解决情绪和情绪的早期干扰，在情绪发展的经验数据基础上增加了一个新的ED模块。ED模块以家长情绪学习技能为目标，目的是培训家长成为孩子更有效的情绪老师和教练。ED模块的目标是提高孩子的情绪识别和调节能力，或称“情绪能力”。PCIT-ED的先导性随机对照试验证明了疗效的可行性和前景。根据这些发现，这项申请提出了一个大规模的PCIT-ED治疗PO-MDD的动力良好的RCT，而不是等待名单对照，之后受试者将接受积极的治疗。其目的是严格测试PCIT-ED的疗效，估计准确的效应大小，并调查治疗反应的中介和调节因素。

DESCRIPTION (provided by applicant): A Randomized Controlled Trial of PCIT-ED for Preschool Depression Data from several independent research groups have demonstrated that the onset of DSM-IV depressive disorders may occur as early as the preschool period. A stable and specific symptom constellation, family history of related disorders, characteristic alterations in stress cortisol reactivity as well as homotypic continuity with depression at school age provide strong support for the principle that preschool depression represents an early onset form of the later childhood disorder. Epidemiological studies from both U.S. and European sites estimate the prevalence rate of preschool onset depression (PO-MDD) at 1-2%, the same rate found in school- aged children. New data from our lab suggest that depressed preschoolers display alterations in functional brain activity similar to that found in adult depression. These brain changes were detected both during an acute preschool episode and later at school age, even after the depressive episode remitted. These findings taken together underscore the need for treatment of MDD during the preschool period. However, because PO-MDD has only recently been recognized, investigations of treatments remain uncharted. The need for effective treatments for PO-MDD go beyond the important goal of helping affected preschoolers but may also have implications for earlier and potentially more effective interventions in this chronic and relapsing disorder. Based on the large effect sizes reported in early interventions in several preschool disorders, an early intervention for PO-MDD, Parent Child Interaction Therapy Emotion Development (PCIT-ED) was developed and pilot tested. PCIT-ED is an expansion of PCIT, a well-known, widely used and proven effective treatment for preschool disruptive disorders. To address early disturbances of mood and affect, a novel ED module was added based on empirical data in emotion development. The ED module targets parent emotion learning skills with the goal of training the parent to serve as a more effective emotion teacher and coach to the child. The goal of the ED module is to enhance the child's capacity for emotion recognition and regulation or "emotional competence." A pilot randomized controlled trial of PCIT-ED was conducted demonstrating feasibility and promise of efficacy. Following these findings, this application proposes a large scale well powered RCT of PCIT-ED for PO-MDD compared to a wait list control after which subjects will receive the active treatment. The aim is to rigorously test the efficacy of PCIT-ED, to estimate accurate effect sizes and to investigate mediators and moderators of treatment response.