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

Primary Purpose

Covid19, Pediatric Psychiatric Disorder, Psychological Stress

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Educational Program (CARTOON)
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 focused on measuring Educational Program, education

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

Participants received no specific educational program

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.

Outcomes

Primary Outcome Measures

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.
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 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.

Secondary Outcome Measures

Nationality of parents
Is there a correlation of the Nationality of the parents with emotional and knowledge outcomes of the children
First language of parents
Is there a correlation of the first language of the parents with emotional and knowledge outcomes of the children
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
Profession of the parents
Is there a correlation of the profession of the parents with emotional and knowledge outcomes of the children
Financial standing of the parents
Is there a correlation of the financial standing of the parents with emotional and knowledge outcomes of the children
Housing conditions of the family
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
Is there a correlation of the psychological or physical burden in the family with emotional and knowledge outcomes of the children

Full Information

First Posted
January 10, 2021
Last Updated
January 24, 2021
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT04724616
Brief Title
CARTOON: CoronAviRus (COVID-19) educaTional prOgram fOr childreN
Acronym
CARTOON
Official Title
CARTOON: CoronAviRus educaTional prOgram fOr childreN to Promote Knowledge and Hygiene Measures and Dispel Fear During the COVID- 19 Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 6, 2021 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Pediatric Psychiatric Disorder, Psychological Stress
Keywords
Educational Program, education

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants received no specific educational program
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Educational Program (CARTOON)
Other Intervention Name(s)
Education, Psycho-educational intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Emotional Outcome
Description
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.
Time Frame
Baseline (before the intervention), 1 day after the intervention and three months after the intervention
Title
Change of Knowledge Outcome
Description
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.
Time Frame
Baseline (before the intervention), 1 day after the intervention and three months after the intervention
Title
Baseline Behavior of the Participants
Description
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.
Time Frame
Baseline (before the intervention)
Secondary Outcome Measure Information:
Title
Nationality of parents
Description
Is there a correlation of the Nationality of the parents with emotional and knowledge outcomes of the children
Time Frame
Baseline (before the intervention)
Title
First language of parents
Description
Is there a correlation of the first language of the parents with emotional and knowledge outcomes of the children
Time Frame
Baseline (before the intervention)
Title
Highest degree of school education
Description
Is there a correlation of the highest degree of school education of the parents with emotional and knowledge outcomes of the children
Time Frame
Baseline (before the intervention)
Title
Profession of the parents
Description
Is there a correlation of the profession of the parents with emotional and knowledge outcomes of the children
Time Frame
Baseline (before the intervention)
Title
Financial standing of the parents
Description
Is there a correlation of the financial standing of the parents with emotional and knowledge outcomes of the children
Time Frame
Baseline (before the intervention)
Title
Housing conditions of the family
Description
Is there a correlation of the housing condition of the family with emotional and knowledge outcomes of the children
Time Frame
Baseline (before the intervention)
Title
Psychological or physical illness in the family
Description
Is there a correlation of the psychological or physical burden in the family with emotional and knowledge outcomes of the children
Time Frame
Baseline (before the intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp Steinbauer, Dr.
Phone
43 664 38 88 180
Email
philipp.steinbauer@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp Steinbauer, Dr.
Organizational Affiliation
Comprehensive Center For Pediatrics, Division of Neonatology, Intensive Care Medicine and Neuropediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michaela Reiger, BA
Phone
+43014040067400
Email
ausstellungsstrasse@wien.kinderfreunde.at
First Name & Middle Initial & Last Name & Degree
Philipp Steinbauer, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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