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临床试验/NCT04724616
NCT04724616已完成不适用

CARTOON: CoronAviRus educaTional prOgram fOr childreN to Promote Knowledge and Hygiene Measures and Dispel Fear During the COVID- 19 Pandemic

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2021年1月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
1
主要终点
Baseline Behavior of the Participants

研究概览

简要总结

Our study aims to investigate whether our CoronAviRus educaTional prOgram fOr children (CARTOON) facilitates the adherence to hygiene measures and is feasible to dispel fear in preschool children (3-6 years old) during the pandemic.

详细描述

This prospective randomized controlled trial will be performed at four kindergartens in Vienna, Austria. About 60 children between three and six years of age attending kindergarten will be included in the study. Prior inclusion in the study eligible adults have to sign a parental consent form. We will randomly assign 30 children to the intervention group (n=30) and 30 children to the control group (n=30). Depending on the randomization (intervention group vs. control group), children either receive our CARTOON (intervention group) or no educational training (control group).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children between three and six years who are attending kindergarten
  • •consent of the parents and the participants

排除标准

  • •physically unable to complete any of the training exercises
  • •German skills not good enough to follow the instructions

研究组 & 干预措施

Control Group

No Intervention

Participants received no specific educational program

Intervention Group

Experimental

Participants received our educational program for five days, with one teaching session per day. Every teaching session will be conducted for 60 minutes in a group of up to 6 children by a trained member of our staff.

干预措施: Educational Program (CARTOON) (Other)

结局指标

主要结局

Baseline Behavior of the Participants

时间窗: Baseline (before the intervention)

Behavior will be assessed by using the parent and teacher reported Child Behavior Checklist (CBCL). The CBCL is a questionnaire for parents and teachers revealing behavioral problems of children and adolescents. In the CBCL/1.5-5, two evaluation methods are available. In the first evaluation method, questions are grouped in seven empirically based problem scales including emotionally reactive, anxious/depressed, aggressive behavior, attention problems, somatic complaints, sleep problems, and withdrawn.

Change of Emotional Outcome

时间窗: Baseline (before the intervention), 1 day after the intervention and three months after the intervention

For the assessment of emotional wellbeing, fear, and burden during the pandemic we will use the emotional scale which measure feelings including emotional wellbeing, fear, and burden. Since it is often hard for children to describe their own feelings with words, we will use the emotional scales of Gräßler and colleagues. These scales use child-friendly illustrated pictures and can be used to support the children in naming their feelings including emotional wellbeing, fear, and burden.

Change of Knowledge Outcome

时间窗: Baseline (before the intervention), 1 day after the intervention and three months after the intervention

The corona quiz consists of a 18-item questionnaire and covers theoretical and practical knowledge. Content validity of the knowledge test was reviewed by an expert panel consisting of three psychologists with expertise in children health, one kindergarten teacher, and one pediatrician.

次要结局

  • Psychological or physical illness in the family(Baseline (before the intervention))
  • First language of parents(Baseline (before the intervention))
  • Highest degree of school education(Baseline (before the intervention))
  • Housing conditions of the family(Baseline (before the intervention))
  • Financial standing of the parents(Baseline (before the intervention))
  • Nationality of parents(Baseline (before the intervention))
  • Profession of the parents(Baseline (before the intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Philipp Steinbauer

Dr.

Medical University of Vienna

研究点 (1)

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