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

Not Applicable

Completed

• Conditions: Pediatric Psychiatric Disorder; Covid19; Psychological Stress
• Interventions: Other: Educational Program (CARTOON)

• Registration Number: NCT04724616
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

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).

Study Timeline

• Study Start: 2021-01-06
• Study First Submitted: 2021-01-10
• Study First Submitted QC: 2021-01-24
• Study First Posted: 2021-01-26
• Primary Completion: 2023-01-12
• Study Completion: 2023-01-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Educational Program (CARTOON)	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.

Primary Outcome Measures

Name	Time	Method
Baseline Behavior of the Participants	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	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	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria