CARTOON: CoronAviRus (COVID-19) educaTional prOgram fOr childreN

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Covid19, Pediatric Psychiatric Disorder, Psychological Stress

Intervention / Treatment
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* Other: Educational Program (CARTOON)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between three and six years who are attending kindergarten consent of the parents and the participants Exclusion Criteria: physically unable to complete any of the training exercises German skills not good enough to follow the instructions

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Participants received no specific educational program | |
| Experimental: Intervention Group<br>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. | Other: Educational Program (CARTOON)<br>* CARTOON is an interdisciplinary psychoeducational intervention program. It consists of five teaching sessions: 1) hand hygiene, not grasping the face, 2) sneezing etiquette, 3) wearing a mask, 4) social distancing, and 5) theoretical knowledge about the coronavirus. Using special exercises and games, information about the coronavirus is conveyed in a child friendly manner.<br>* Other names: Psycho-educational intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Emotional Outcome | 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. | Baseline (before the intervention), 1 day after the intervention and three months after the intervention | 
| Change of Knowledge Outcome | 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. | Baseline (before the intervention), 1 day after the intervention and three months after the intervention | 
| Baseline Behavior of the Participants | 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. | Baseline (before the intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nationality of parents | Is there a correlation of the Nationality of the parents with emotional and knowledge outcomes of the children | Baseline (before the intervention) | 
| First language of parents | Is there a correlation of the first language of the parents with emotional and knowledge outcomes of the children | Baseline (before the intervention) | 
| Highest degree of school education | Is there a correlation of the highest degree of school education of the parents with emotional and knowledge outcomes of the children | Baseline (before the intervention) | 
| Profession of the parents | Is there a correlation of the profession of the parents with emotional and knowledge outcomes of the children | Baseline (before the intervention) | 
| Financial standing of the parents | Is there a correlation of the financial standing of the parents with emotional and knowledge outcomes of the children | Baseline (before the intervention) | 
| Housing conditions of the family | Is there a correlation of the housing condition of the family with emotional and knowledge outcomes of the children | Baseline (before the intervention) | 
| Psychological or physical illness in the family | Is there a correlation of the psychological or physical burden in the family with emotional and knowledge outcomes of the children | Baseline (before the intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Educational Program, education