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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19; Psychological Stress; Pediatric Psychiatric Disorder
• Intervention / Treatment: Other: Educational Program (CARTOON)

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 Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philipp Steinbauer, Dr.; Phone Number: 43 664 38 88 180; Email: philipp.steinbauer@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1020
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Participants received no specific educational program
Experimental: Intervention Group; 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); 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.; Other Names: Education; Psycho-educational intervention

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Philipp Steinbauer, Dr., Comprehensive Center For Pediatrics, Division of Neonatology, Intensive Care Medicine and Neuropediatrics

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2021
• Primary Completion (Actual): January 12, 2023
• Study Completion (Actual): January 12, 2023

Study Registration Dates

• First Submitted: January 10, 2021
• First Submitted That Met QC Criteria: January 24, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: education; Educational Program
• Additional Relevant MeSH Terms: Behavioral Symptoms; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Problem Behavior; Stress, Psychological; Mental Disorders
• Other Study ID Numbers: 2128/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No