Covid19CARTOONNCT04724616
CARTOON: CoronAviRus (COVID-19) educaTional prOgram fOr childreN
A study testing Educational Program (CARTOON) in people with Covid19 and Pediatric Psychiatric Disorder, run by Medical University of Vienna at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Pediatric Psychiatric Disorder, Psychological Stress
- What is being tested?
- Educational Program (CARTOON)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteAustria
- Study dates
- 6 Jan 2021to 12 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between three and six years who are attending kindergarten
- consent of the parents and the participants
Who cannot join
- physically unable to complete any of the training exercises
- German skills not good enough to follow the instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Being tested
- Educational Program (CARTOON)
- Keywords
- Educational Program, education
- Medical subject headings
- COVID-19, Neurodevelopmental Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Program (CARTOON)Other
Also called Education, Psycho-educational intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants received no specific educational program |
| Intervention Group | Experimental | 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. Receives: Other: Educational Program (CARTOON) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (before the intervention)
Secondary outcomes (7)
Nationality of parents
Is there a correlation of the Nationality of the parents with emotional and knowledge outcomes of the children
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (before the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start6 Jan 2021
- Primary completion12 Jan 2023
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Steinbauer, Medical University of Vienna
- Investigators
- Philipp Steinbauer, Dr., Principal investigator, Comprehensive Center For Pediatrics, Division of Neonatology, Intensive Care Medicine and Neuropediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724616
- Sponsor's protocol ID
- 2128/2020
- Acronym
- CARTOON
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2021
- Last updated
- 16 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Steinbauer P, Bichler M, Fuiko R, Seferagic S, Haas H, Lisy T, Weinmuller S, Berger A, Olischar M, Panagl A, Giordano V. CARTOON-based educational intervention for children to foster hygiene knowledge and emotional resilience in preschool children: a randomized controlled trial. Front Pediatr. 2025 Apr 11;13:1514793. doi: 10.3389/fped.2025.1514793. eCollection 2025.
PubMed 40292121
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CARTOON: CoronAviRus educaTional prOgram fOr childreN to Promote Knowledge and Hygiene Measures and Dispel Fear During the COVID- 19 Pandemic
- ClinicalTrials.gov ID
- NCT04724616
- Acronym / sponsor ID
- CARTOON / 2128/2020
- Keywords
- Educational Program, education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants received no specific educational program |
| Intervention Group | Experimental | Other: 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children between three and six years who are attending kindergarten
- consent of the parents and the participants
Key exclusion criteria (2 listed)
- physically unable to complete any of the training exercises
- German skills not good enough to follow the instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Program (CARTOON)Also: Education, Psycho-educational interventionCARTOON 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 | Intervention Group |
Primary outcome
Change of Emotional Outcome
Time frame: 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
Time frame: 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.
Baseline Behavior of the Participants
Time frame: 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.
7 secondary outcomes
Nationality of parents
Time frame: Baseline (before the intervention)
First language of parents
Time frame: Baseline (before the intervention)
Highest degree of school education
Time frame: Baseline (before the intervention)
Profession of the parents
Time frame: Baseline (before the intervention)
Financial standing of the parents
Time frame: Baseline (before the intervention)
Housing conditions of the family
Time frame: Baseline (before the intervention)
Psychological or physical illness in the family
Time frame: Baseline (before the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Derived from this study: PubMed 40292121Steinbauer P, Bichler M, Fuiko R, Seferagic S, Haas H, Lisy T, Weinmuller S, Berger A, Olischar M, Panagl A, Giordano V. CARTOON-based educational intervention for children to foster hygiene knowledge and emotional resilience in preschool children: a randomized controlled trial. Front Pediatr. 2025 Apr 11;13:1514793. doi: 10.3389/fped.2025.1514793. eCollection 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philipp Steinbauer, Dr. principal investigator
Comprehensive Center For Pediatrics, Division of Neonatology, Intensive Care Medicine and Neuropediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Program (CARTOON) in people with Covid19 and Pediatric Psychiatric Disorder, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Emotional Outcome (time frame: Baseline (before the intervention), 1 day after the intervention and three months after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04724616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.