A RANDOMIZED CONTROLLED TRIAL OF PCIT-ED FOR PRESCHOOL DEPRESSION

描述（由申请人提供）：一项PCIT-ED治疗学龄前抑郁症的随机对照试验来自几个独立研究小组的数据表明，DSM-IV抑郁症的发作可能早在学龄前时期就发生了。稳定且特异的症状群、相关疾病家族史、特征性改变 在应激皮质醇反应性以及在学龄期抑郁症同型连续性中， 这有力地支持了学前抑郁症是儿童后期疾病的一种早期发作形式的原则。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，抑郁的学龄前儿童显示出与成人抑郁症相似的功能性大脑活动的改变。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。这些发现共同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，治疗的研究仍然未知。对PO-MDD的有效治疗的需求超出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非慢性疾病的早期和潜在更有效的干预产生影响。 复发性疾病基于在几种学龄前疾病的早期干预中报告的大效应量，开发并初步测试了PO-MDD的早期干预，亲子互动疗法情感发展（PCIT-ED）。PCIT-ED是PCIT的扩展，PCIT是一种众所周知的，广泛使用的和被证明有效的学前破坏性疾病治疗方法。为了解决情绪和情感的早期障碍，一个新的艾德模块增加了基于情感发展的经验数据。艾德模块的目标是父母的情感学习技能，培训父母作为一个更有效的情感教师和教练的孩子。艾德模块的目标是提高孩子的情绪识别和调节能力或“情绪能力”。“进行了一项PCIT-ED的试点随机对照试验，证明了其可行性和有效性。根据这些发现，本申请提出了一项针对PO-MDD的PCIT-ED的大规模把握度良好的RCT，与等待列表对照相比，之后受试者将接受活性治疗。其目的是严格测试PCIT-ED的疗效，估计准确的效应量，并调查治疗反应的介质和调节剂。

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.