A Randomized Controlled Trial of PCIT-ED For Preschool Depression

描述（由申请人提供）：这项拟议的竞争性补充/修订扩展了这项正在进行的亲子互动疗法情绪发展（PCIT-ED）随机对照试验的目标，增加了三个核心情绪领域的免费神经测量，这些领域是直接针对治疗的。这包括通过奖励处理测量的享乐基调和通过对失去/缺乏奖励以及情绪调节的反应测量的负面情绪反应。PCIT-ED是一种针对学龄前抑郁症的早期心理治疗干预，直接针对情绪反应性，享乐基调和情绪调节。这些情感领域的行为测量正在进行的随机对照试验，但这个补充将允许一个独特的调查这些结构的神经相关。治疗的目的是针对这些新兴的情绪发展的组成部分，已知在学龄前抑郁症中会发生变化，通过在这段相对更大的神经可塑性和快速发展变化的时期内通过亲子关系采取行动。研究领域标准（RDoC）提供了一个框架，在其中识别和测试核心行为和神经维度有助于改变与早发性抑郁症相关的享乐加工和情绪反应和调节。抑郁症与青少年和成年人对奖励的反应性降低和对损失的反应性增强有关。我们建议研究抑郁症学龄前儿童（PO-MDD）治疗前，治疗中和治疗后使用有效的ERP和功能磁共振成像标记物的反应，奖励和损失以前用于表征抑郁症相关的改变，在这些领域。我们将测试的假设，即行为和神经指标的反应奖励和损失将改善PCIT-ED的结果，这些神经措施将预测谁是最有可能作出反应。这些数据可以提供治疗效果的翻译生物标志物和治疗反应的预测因子的关键证据，在早期神经可塑性发育期间特别重要。拟议的补充将通过使用年龄适当的范例，测量治疗前和治疗后/等待条件，增加这些特定结构的ERP和fMRI测量，以告知治疗反应的预测因素和潜在的变化机制。这项附加研究符合NIMH战略计划和RDoC倡议，通过调查抑郁症的大脑行为关系，并在发育早期针对它们。正在进行的R 01是第一个大规模的随机对照试验的早期干预抑郁症，以我们的知识，因此提供了一个前所未有的机会，调查情感系统的变化，在非常年幼的儿童从行为和神经的角度。我们包括ERP和功能磁共振成像，以确定这些补充措施是否识别独特的或重叠的变化的神经相关/机制和/或治疗反应的预测变量。

DESCRIPTION (provided by applicant): This proposed competitive supplement/revision extends the aims of this ongoing randomized controlled trial of Parent Child Interaction Therapy Emotion Development (PCIT-ED) by adding complimentary neural measures of three core emotion domains that are directly targeted by the treatment. This includes hedonic tone measured by reward processing and negative emotion reactivity measured by response to loss/lack of reward as well as emotion regulation. PCIT-ED is an early psychotherapeutic intervention for preschool depression that directly targets emotion reactivity, hedonic tone and emotion regulation. These emotion domains are measured behaviorally in the ongoing RCT, but this supplement will allow a unique investigation of the neural correlates of these constructs. The treatment is designed to target these emerging components of emotion development, known to be altered in preschool depression, by acting through the parent child relationship during this period of relatively greater neuroplasticity and rapid developmental change. The Research Domain Criteria (RDoC) provides a framework in which to identify and test core behavioral and neural dimensions contributing to altered hedonic processing and emotion reactivity and regulation associated with early onset depression. Depression is associated with both decreased responsiveness to reward and enhanced responsiveness to loss in adolescents and adults. We propose to study depressed preschoolers (PO-MDD) prior to treatment, mid-treatment and post-treatment using well-validated ERP and fMRI markers of response to reward and loss previously used to characterize depression related alterations in these domains. We will test the hypotheses that behavioral and neural indicators of responsiveness to reward and loss will improve as a result of PCIT-ED, and that these neural measures will predict who is most likely to respond. Such data could provide crucial evidence of translational biomarkers of treatment efficacy and predictors of treatment response, of particular importance during this early neuroplastic developmental period. The proposed supplement will add ERP and fMRI measures of these specific constructs through the use of age appropriate paradigms, measured pre and post treatment/wait condition, to inform predictors of treatment response and potentially mechanisms of change. This add-on study is in line with the NIMH strategic plan and the RDoC initiative by investigating brain behavior relationships central to depression and targeting them early in development. The ongoing R01 is the first large scale RCT of an early intervention for depression to our knowledge and therefore provides an unprecedented opportunity to investigate changes in affective systems in very young children from both behavioral and neural perspectives. We include both ERP and fMRI to determine whether these complementary measures identify unique or overlapping variance in the neural correlates/mechanisms of change and/or the predictors of treatment response.