Explanatory Clinical Trial of a Novel Parent Intervention for Childhood Anxiety

针对儿童焦虑的新型家长干预的解释性临床试验

• 批准号: 8927692
• 负责人: Eli Lebowitz
• 金额: $ 17.56万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-15 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8927692
• 关键词: Aftercare; Animals; Anxiety; Anxiety Disorders; Area; Behavior; Behavior Disorders; Behavioral; Behavioral Research; Biological; Child; Child Rearing; Childhood; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Code; Cognitive Therapy; Data; Development; Diagnostic; Distress; Educational process of instructing; Educational workshop; Emotional disorder; Emotions; Ensure; Environment; Etiology; Family; Feeling; Goals; Grant; Health; Human; Individual; Intervention; Intervention Studies; Investigation; Knowledge; Laboratories; Lead; Learning; Link; Maintenance; Measures; Mediation; Mediator of activation protein; Mentors; Mentorship; Methods; Modeling; Outcome; Oxytocin; Parents; Pattern; Preparation; Process; Psychotherapy; Questionnaires; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Reading; Research; Risk; Scientist; Series; Severities; Shapes; Specificity; Statistical Methods; Symptoms; System; Testing; Training; Training Activity; Treatment outcome; Visit; Work; aged; anxious; base; behavior observation; biological research; career; childhood anxiety; contingency management; cost; design; driving behavior; improved; meetings; next generation; novel; parental influence; parental role; patient oriented; personalized medicine; programs; protective behavior; response; skills; theories; treatment effect; treatment response; trial comparing

DESCRIPTION (provided by applicant): This K23 application seeks support essential to my development as a patient oriented clinical investigator able to design, execute, and evaluate, theory-driven explanatory randomized clinical trials (RCTs). I am building a multi-method program of research to study how parents are drawn into accommodating their child's anxiety, and to intervene by modifying these patterns of enmeshment. I have conducted small clinical trials and have examined key biological and behavioral parent markers. I need to develop my skill and expertise in three core areas: 1) Designing and executing explanatory RCTs~ 2) Integrating bio-behavioral markers in explanatory RCTs~ 3) Applying statistical methods to test hypotheses of mediation and moderation in explanatory RCTs. To achieve these goals I have developed a training plan including regular meetings with all my sponsors, visits to other laboratories, courses seminars and workshops, independent reading, and scientific meetings. The superb and dedicated mentorship team ensures I receive strong, state of the art training. Their mentorship, the training activities, and the outstanding academic environment at the Yale Child Study Center, will provide me with the skills to launch an independent research career, starting with my first R01. The role of parents in the treatment of childhood anxiety remains unresolved. Including parents in the treatment process has not yielded superior effects compared to individual cognitive behavioral therapy (ICBT). One plausible conclusion from these data is that parent work cannot enhance effects treatment effects. This K23 focuses on an alternative plausible conclusion: That parent interventions need to be informed by theoretical working models of parent-specific mechanisms of change that are not targeted in ICBT~ and that parent interventions need to be evaluated in explanatory clinical trials asking not only 'doe treatment work?' but also 'how and for whom does treatment work?' Underlying systems that shape parents' responses to child anxiety provide clues to such parent-specific targets for intervention, and point to potential mediators and moderators of treatment response. Identifying mediators and moderators of response to parent interventions can enhance child anxiety outcomes and advance the goal of personalized psychotherapy. The SPACE Program (Supportive Parenting For Anxious Childhood Emotions) is a parent-based intervention that targets family accommodation (FA), of child anxiety. I propose an integrated explanatory clinical trial of SPACE, with ICBT as baseline comparison condition. The trial asks 3 main questions: 1) Will SPACE lead to significantly lower levels of FA compared to ICBT? 2) Will reducing FA lead to positive child outcomes? 3) Will key biological and behavioral markers (i.e., maternal oxytocin, autonomy granting, over involvement, sensitivity) moderate child outcomes? Children aged 7-14 (n=120), with primary anxiety disorders, will be randomized to either ICBT or SPACE. Results of this trial will guide the preparation of an R01 and have the potential to enhance treatment outcomes for the highly prevalent child anxiety disorders.

描述（由申请人提供）：本K23申请寻求对我的发展至关重要的支持，作为一名以患者为导向的临床研究者，能够设计，执行和评估理论驱动的解释性随机临床试验（RCT）。我正在建立一个多方法的研究计划，研究父母是如何被吸引到适应他们孩子的焦虑，并通过修改这些模式进行干预。我进行了小型临床试验，并检查了关键的生物和行为父母标记。我需要在三个核心领域发展我的技能和专业知识：1）设计和执行解释性RCT-2）在解释性RCT中整合生物行为标记-3）应用统计方法来检验解释性RCT中的中介和适度假设。为了实现这些目标，我制定了一个培训计划，包括与所有赞助商定期会面，参观其他实验室，课程研讨会和讲习班，独立阅读和科学会议。精湛和敬业的导师团队确保我接受强大的，最先进的培训状态。他们的指导，培训活动和耶鲁儿童研究中心出色的学术环境，将为我提供技能，从我的第一个R 01开始，开始独立的研究生涯。父母在治疗儿童焦虑症中的作用仍然没有得到解决。与个体认知行为疗法（ICBT）相比，将父母纳入治疗过程并没有产生上级效果。从这些数据中得出的一个似乎合理的结论是，父母的工作不能提高治疗效果。这个K23集中在一个替代的似是而非的结论：父母干预需要由理论工作模型的父母特定的变化机制，而不是在ICBT的目标，父母干预需要在解释性临床试验中进行评估，不仅问“做治疗工作？但也要问治疗是如何起作用的，对谁起作用？“塑造父母对儿童焦虑反应的潜在系统为这种父母特定的干预目标提供了线索，并指出了治疗反应的潜在中介者和调节者。识别中介和调解人的父母干预措施的反应，可以提高儿童焦虑的结果和推进个性化的心理治疗的目标。空间计划（支持性育儿焦虑儿童情绪）是一个以父母为基础的干预，针对家庭住宿（FA），儿童焦虑。我提出了一个综合的解释性临床试验的空间，与ICBT作为基线比较条件。该试验提出了3个主要问题：1）与ICBT相比，SPACE是否会导致FA水平显着降低？2)减少FA会带来积极的儿童结果吗？3)将关键的生物和行为标记（即，母亲催产素，自主权授予，过度参与，敏感性）中度儿童结局？患有原发性焦虑症的7-14岁儿童（n=120）将被随机分配到ICBT或SPACE组。这项试验的结果将指导R 01的准备，并有可能提高高度流行的儿童焦虑症的治疗效果。