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

Covid19 Clinical Trial

— CARTOON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04724616
• Other study ID #: 2128/2020
• Status: Completed
• Phase: N/A
• Start date: January 6, 2021
• Est. completion date: January 12, 2023

Study information

• Verified date: January 2024
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 12, 2023
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Mental Disorders
• Pediatric Psychiatric Disorder
• Problem Behavior
• Psychological Stress
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)