Prevention of Anxiety in High-Risk Pre-School Children

描述（由申请人提供）：焦虑症是较为普遍的精神疾病之一。他们通常在儿童时期发病，然后跟随一个慢性和波动的过程进入成年期。尽管对焦虑的成年人和年龄较大的儿童进行心理治疗的文献已经建立，但对7岁之前儿童的焦虑治疗效果的数据却很少。在美国任何年龄段的样本中都没有对照的焦虑预防试验。鉴于焦虑症的高患病率、早发性和未经治疗的损害后果，显然有必要采取公共卫生战略，以便及早发现和干预。本R34提案将为具有显著阈下焦虑的学龄前儿童制定一种指示性预防措施，然后获得其可行性、可接受性和潜在功效的数据。在研究的第一阶段，我们将为焦虑学龄前儿童及其父母创建一个人工干预，建立招募程序，对治疗师和评估人员进行培训，并对10名儿童及其家庭进行干预的初步开放试点试验。在第二阶段，我们将筛选纽约市公立学校学前班的4岁儿童。我们将招募64名焦虑水平持续升高的受试者，他们目前不符合DSM-IV焦虑或情绪障碍的诊断标准，并将他们随机分配到12周的干预组或等待名单对照组。所有受试者将在基线、立即干预前和干预后以及3个月随访时进行评估。本研究的目的是通过评估招募、项目可行性和可接受性、流失率、缺失数据模式和估计干预对主要结局（儿童焦虑和社会功能）和目标近端危险因素（父母教养和儿童社会情感功能）的影响，为全面干预试验的设计提供信息（R01）。

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).