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School-Based Treatment for Early Childhood Anxiety

2022年2月22日 更新者:University of Colorado, Denver

A Pilot Study of a School-Based Treatment for Early Childhood Anxiety

This pilot will be used for academic research, in hopes of developing effective treatments for early childhood anxiety. The intervention is an adaptation of Parent-Child Interaction Therapy (PCIT). PCIT is an evidence-based intervention, rooted in attachment and social learning theory. In recent years, researchers have successfully adapted PCIT to address anxiety in a clinical setting (PCIT-CALM). In this pilot study, we will be applying the PCIT-CALM intervention in the school setting, emphasizing teachers as a therapeutic agent of change.

PCIT is unique because the child's caregiver is trained on how to use therapeutic techniques, and then receives live coaching via a "bug in the ear" as they learn to implement the new skills. In this pilot study, both parents and teachers will be taught skills to create a therapeutic relationship and address anxiety. After these teaching sessions, the child's teacher will receive coaching in the classroom to implement the skills. The intervention will last approximately 12 weeks.

研究概览

研究类型

介入性

注册 (实际的)

7

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Colorado
      • Denver、Colorado、美国、80222
        • Montessori School of Denver

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

2年 至 7年 (孩子)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Scores in the at-risk or clinical range for anxiety on the BASC-3 or CBCL (which will be filled out by a parent and teacher to determine eligibility)
  • Child must be enrolled at the Montessori School of Denver where the intervention is being conducted.

Exclusion Criteria:

  • None if other criteria are met.
  • Comorbidity will not exclude a child, but if comorbidities are discovered for which there are other evidence-based treatments available, parents will be encouraged to seek additional resources.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Intervention Group
This study consists of one arm, an intervention group.
This intervention is designed to treat early childhood anxiety. It is an adaptation of parent-child interaction therapy (PCIT), in which teachers rather than parents are targeted as the therapeutic agent of change. The intervention follows the procedures of the CALM protocol, in which caregivers are taught play therapy skills to support and address anxious behaviors and avoidance.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Measuring Changes in scores on Behavior Assessment System for Children (BASC-3)
大体时间:Pre- treatment Baseline and immediately following the intervention; An additional data collection was later added for longitudinal data that will be collected in October.
A normed clinical rating scale for assessing behavior and mental health; This tool was chosen due to the norms for young children and the ability to have both parent and teacher rating scales.
Pre- treatment Baseline and immediately following the intervention; An additional data collection was later added for longitudinal data that will be collected in October.
Measuring Changes in scores on Child Behavior Checklist (CBCL)
大体时间:Pre- treatment Baseline and immediately following the intervention; An additional data collection was later added for longitudinal data that will be collected in October.
A normed clinical rating scale for assessing behavior and mental health; This tool was chosen due to the norms for young children and the ability to have both parent and teacher rating scales.
Pre- treatment Baseline and immediately following the intervention; An additional data collection was later added for longitudinal data that will be collected in October.

次要结果测量

结果测量
措施说明
大体时间
Therapy Attitude Inventory
大体时间:Immediately following the intervention
A brief questionnaire to assess how well the intervention worked for the adults involved. The questionnaire includes 10 questions with a Likert scale response (1-5; 1 indicating little value from the intervention and 5 indicating it was highly beneficial.
Immediately following the intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Victoria Virlee、University of Colorado, Denver

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年3月1日

初级完成 (实际的)

2021年11月1日

研究完成 (实际的)

2021年11月1日

研究注册日期

首次提交

2021年3月18日

首先提交符合 QC 标准的

2021年3月19日

首次发布 (实际的)

2021年3月23日

研究记录更新

最后更新发布 (实际的)

2022年2月24日

上次提交的符合 QC 标准的更新

2022年2月22日

最后验证

2022年2月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 21-2523

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

Currently, there is no plan to share IPD, but if data would be useful to others it has not been ruled out.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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