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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04724616
Other study ID # 2128/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
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