A RANDOMIZED CONTROLLED TRIAL OF PCIT-ED FOR PRESCHOOL DEPRESSION

PCIT-ED 治疗学前抑郁症的随机对照试验

• 批准号: 8527571
• 负责人: JOAN L. LUBY
• 金额: $ 75.99万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-17 至 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8527571
• 关键词: Acute; Address; Adult; Affect; Aftercare; Age; Behavior Therapy; Brain; Characteristics; Child; Childhood; Chronic; Clinical; Competence; DSM-IV; Data; Depressed mood; Depressive disorder; Development; Diagnostic; Disease; Disease remission; Early Intervention; Education; Educational process of instructing; Emotional; Emotions; Epidemiologic Studies; European; Family history of; Goals; Hydrocortisone; Impairment; Intelligence; Intervention; Investigation; Learning; Measures; Mediating; Mediator of activation protein; Mental Depression; Mental disorders; Moods; National Institute of Mental Health; Nursery Schools; Outcome; Parent-Child Relations; Parenting behavior; Parents; Pharmaceutical Preparations; Population; Prevalence; Prevention; Psychotherapy; Public Health; Randomized; Randomized Controlled Trials; Regulation; Relapse; Reporting; Research; School-Age Population; Severities; Site; Stress; Symptoms; Techniques; Testing; Training; Waiting Lists; active method; base; child depression; depressive symptoms; design; disturbance in affect; early onset; effective intervention; effective therapy; efficacy testing; follow-up; meetings; novel; prevent; public health relevance; skills; teacher; therapy design; trait; treatment effect; treatment response; trend; trial comparing

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.

描述（由申请人提供）：PCIT-ED 治疗学前抑郁症的随机对照试验 来自多个独立研究小组的数据表明，DSM-IV 抑郁症可能早在学龄前时期就开始发作。稳定且特定的症状群、相关疾病的家族史、特征性改变 在应激皮质醇反应以及学龄抑郁症的同型连续性中提供 强烈支持这样的原则：学前抑郁症是儿童后期疾病的早期发病形式。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。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功能性大脑活动变化。这些大脑变化在学龄前急性发作期间和学龄后期，甚至在抑郁发作缓解后都被发现。这些发现共同强调了在学龄前期间治疗 MDD 的必要性。然而，由于 PO-MDD 最近才被认识，治疗方法的研究仍然未知。对 PO-MDD 进行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潜在的更有效的干预措施产生影响。 复发性疾病。根据多种学前障碍早期干预措施所报告的巨大效应，针对 PO-MDD 的早期干预措施——亲子互动疗法情绪发展 (PCIT-ED) 被开发出来并进行了试点测试。 PCIT-ED 是 PCIT 的扩展，PCIT 是一种众所周知的、广泛使用且被证明有效的学前破坏性障碍治疗方法。为了解决情绪和情感的早期干扰，根据情绪发展的经验数据添加了一个新的 ED 模块。 ED模块以家长情绪学习技能为目标，旨在培训家长成为孩子更有效的情绪老师和教练。 ED 模块的目标是增强孩子的情绪识别和调节能力或“情绪能力”。进行了 PCIT-ED 的随机对照试验，证明了可行性和疗效前景。根据这些发现，本申请提出了针对 PO-MDD 的 PCIT-ED 的大规模、功效良好的随机对照试验，与等待名单对照相比，之后受试者将接受积极治疗。目的是严格测试 PCIT-ED 的疗效，估计准确的效应大小并研究治疗反应的调节因素和调节因素。