Prevention of Anxiety in High-Risk Pre-School Children

预防高危学龄前儿童的焦虑

• 批准号: 7476353
• 负责人: Christopher Paul Lucas
• 金额: $ 25.41万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-08-01 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7476353
• 关键词: 4 year old; Accounting; Age; Anxiety; Anxiety Disorders; Blinded; Caregivers; Child; Child Behavior; Childhood; Chronic; Clinical; Computer information processing; Condition; Country; DSM-IV; Data; Diagnostic; Early identification; Effectiveness of Interventions; Elderly; Emotional; Etiology; Family; Goals; High Prevalence; Intervention; Intervention Trial; Link; Literature; Maintenance; Mediating; Mediation; Mental Depression; Mental disorders; Modeling; Mood Disorders; Outcome; Parenting behavior; Parents; Patient Self-Report; Pattern; Phase; Phase I Clinical Trials; Prevention; Procedures; Psychotherapy; Public Health; Randomized; Randomized Controlled Trials; Rate; Recruitment Activity; Reporting; Risk; Risk Factors; Sampling; Schools; Score; Social Functioning; Training; Treatment Efficacy; Waiting Lists; Week; burden of illness; design; disability; early onset; follow-up; functional outcomes; impression; improved; indicated prevention; pilot trial; programs; size; social skills; teacher

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).

描述（由申请人提供）：焦虑症是更普遍的精神疾病之一。它们通常在童年时期发病，然后经历一个慢性且波动的过程直至成年。尽管有关于针对焦虑成人和年龄较大儿童进行心理治疗的既定文献，但关于 7 岁之前儿童焦虑治疗效果的数据却很少。美国还没有针对任何年龄样本进行焦虑预防对照试验。鉴于未经治疗的焦虑症患病率高、发病早且后果严重，显然有必要采取能够及早识别和干预的公共卫生策略。该R34提案将为患有严重阈下焦虑的学龄前儿童制定一种指示性预防措施，然后获取其可行性、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，对治疗师和评估人员进行培训，并对 10 名儿童及其家庭进行干预措施的初步公开试点试验。在第二阶段，我们将筛选参加纽约市公立学校学前班课程的 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为期 12 周的干预或等待名单控制条件。所有受试者都将在基线、干预前后以及 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、缺失数据模式以及估计干预对主要结局（儿童焦虑和社会功能）和目标近端风险因素（养育和儿童社会情感功能）的干预效果大小，为全面干预试验（R01）的设计提供信息。