Randomized Clinical Trial of a Novel Psychotherapy for Childhood Depression

描述（由申请人提供）：在我们申请的第二次修订中，我们解决了评审员关于我们的比较条件和其他几个设计问题的问题，并提出了一项为期5年的情境情绪调节疗法（CERT）疗效研究，这是一种儿童抑郁症的新型干预措施。CERT是一种基于经验的，对发展敏感的治疗方法，针对抑郁症儿童的情绪调节反应技能，并将父母作为共同治疗师;父母被教导有效地指导他们的孩子完成各种任务，包括在发展中适当使用情绪调节策略来应对经历的痛苦/焦虑。共有100名7-12岁的儿童，患有DSM-IV抑郁症，将被随机分配到CERT或儿童中心疗法（CCT），这是一种基于罗杰斯原则的心理疗法。两种治疗都需要22次治疗，由父母和孩子共同进行：前4个月的每周一次治疗，然后是两周一次的治疗（两个月内），以巩固治疗效果。治疗结束后，将对两组患者进行为期1年的随访，以评估干预措施的长期效果。一个多角度的评估组合（临床访谈和评级，以及父母和孩子的自我评估清单）将提供数据来测试我们的假设。我们假设，CERT将导致更快，更完整，更持久的恢复抑郁症比CCT;症状的改善将介导的改善儿童和父母的自我调节烦躁情绪和改善亲子关系;和治疗结果将缓和基线临床特征的儿童和父母的抑郁症状。一项对20名患有心境恶劣和/或重度抑郁障碍的儿童进行的CERT开放治疗试验显示，高比例的儿童获得了缓解，并在额外的12个月随访中持续缓解。我们提出的项目具有重大的公共卫生意义，因为儿童抑郁症是通往成人抑郁症的门户，成人抑郁症是全球残疾的主要原因之一，目前还没有发表的，经验验证的治疗12岁及以下儿童临床抑郁症的方法。

DESCRIPTION (provided by applicant): In this second revision of our application, we addressed the reviewers' questions about our comparison condition and several other design issues, and propose a 5-year study of the efficacy of Contextual Emotion Regulation Therapy (CERT), a novel intervention for childhood depression. CERT is an empirically based, developmentally sensitive treatment that targets emotion regulation response skills in depressed children, and deploys parents as co-therapists; parents are taught to effectively coach their children in various tasks, including developmentally appropriate use of emotion regulatory strategies in response to experiencing distress/dysphoria. Altogether 100 children, aged 7-12, with a DSM-IV depressive disorder, will be randomly assigned to CERT or Child-Centered Therapy (CCT), a psychotherapy based on Rogerian principles. Both treatments entail 22 sessions, conducted jointly with the parent and child: weekly sessions across the first 4 months are followed by biweekly sessions (across a two month period) to consolidate treatment gains. Both groups will be followed for 1 year after the end of treatment to evaluate the longer-term effects of the interventions. A multi-perspective assessment battery (clinical interviews and ratings, and parent- and child-self rated inventories) will provide the data to test our hypotheses. We hypothesize that CERT will result in more rapid, complete, and sustained recovery from depression than CCT; that symptomatic improvement will be mediated by improvement in children's and parents' self-regulation of dysphoric affect and by improved parent-child relationship; and that treatment outcome will be moderated by baseline clinical characteristics of the child and parental depressive symptoms. An open treatment trial of CERT with 20 children with dysthymic and/or major depressive disorder showed that a high proportion achieved remission, which was sustained across an additional 12 months of follow-up. Our proposed project has great public health significance because childhood depression is a gateway to adult depression, one of the leading causes of disability worldwide, and there are currently no published, empirically validated treatments for clinical depression for referred children aged 12 years and younger.