Prevention of Anxiety in High-Risk Pre-School Children

描述(由申请者提供)：焦虑症是最常见的精神疾病之一。他们通常在儿童时期起病，然后经历一个长期和波动的过程，直到成年。尽管关于焦虑的成年人和年龄较大的儿童的心理治疗已经有了成熟的文献，但关于7岁之前儿童焦虑的任何治疗方法的有效性的数据很少。在美国，没有任何年龄段的受控焦虑预防试验。鉴于未经治疗的焦虑症的高患病率、早发性和有害后果，显然有必要制定公共卫生战略，以便及早发现和干预。这项R34提案将为患有严重阈值下焦虑的学龄前儿童制定一种有针对性的预防措施，然后获得有关其可行性、可接受性和潜在疗效的数据。在研究的第一阶段，我们将为焦虑的学龄前儿童及其家长创建手动干预措施，建立招募程序，对治疗师和评估员进行培训，并对10名儿童及其家人进行干预措施的初步开放试点试验。在第二阶段，我们将对参加纽约市公立学校幼儿园学前班的4岁儿童进行筛查。我们将招募焦虑水平持续升高的受试者，这些受试者目前不符合DSM-IV焦虑或情绪障碍的诊断标准，并将他们随机分为12周干预或等待名单对照条件。所有受试者将在基线、干预前和干预后立即以及3个月的随访时进行评估。本研究的目的是通过评估招募人员、计划的可行性和可接受性、流失率、缺失数据模式和估计干预效果的大小对主要结果(儿童焦虑和社会功能)和目标近端风险因素(父母教养和儿童社会情绪功能)的影响，为全面干预试验(R01)的设计提供信息。

DESCRIPTION (provided by applicant): Anxiety disorders are one of the more prevalent psychiatric conditions. They typically have an onset in childhood and then follow a chronic and fluctuating course into adulthood. Despite an established literature on psychotherapy with anxious adults and older children, there is little data on the efficacy of any treatments for anxiety in children prior to age 7. There are no controlled anxiety prevention trials in US samples of any age. Given the high prevalence, early onset, and impairing consequences of untreated anxiety, public health strategies that would allow early identification and intervention are clearly warranted. This R34 proposal will develop an indicated prevention for pre-school children with significant subthreshold anxiety and then obtain data on its feasibility, acceptability and potential efficacy. In Phase 1 of the study, we will create a manualized intervention for anxious preschoolers and their parents, establish recruitment procedures, conduct training of therapists and evaluators, and carry out an initial open pilot trial of the intervention with 10 children and their families. In Phase 2, we will screen 4-year-old children attending public school Pre-K programs in NYC. We will recruit 64 subjects with persistently elevated levels of anxiety, who do not currently meet diagnostic criteria for a DSM-IV anxiety or mood disorder, and randomize them to a 12-week intervention or a wait-list control condition. All subjects will be assessed at baseline, immediately pre- and post-intervention and at 3-month follow-up. The goal of this study is to inform the design of a full-scale intervention trial (R01) through evaluating recruitment, program feasibility and acceptability, attrition rates, missing data patterns and estimating intervention effect sizes on primary outcomes (child anxiety and social functioning) and targeted proximal risk factors (parenting and child socio-emotional functioning).