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Completed

NCT Number: NCT04724616

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

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.

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Key information

Conditions

Covid19 Behavior Behavioral Symptoms COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mental Disorders Neurodevelopmental Disorders Nidovirales Infections Pediatric Psychiatric Disorder Pneumonia Pneumonia, Viral Psychological Stress RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Stress, Psychological Virus Diseases

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1020, Austria

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Program (CARTOON)

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Nationality of parents

    Time frame: Baseline (before the intervention)

    Is there a correlation of the Nationality of the parents with emotional and knowledge outcomes of the children

  2. First language of parents

    Time frame: Baseline (before the intervention)

    Is there a correlation of the first language of the parents with emotional and knowledge outcomes of the children

  3. Highest degree of school education

    Time frame: Baseline (before the intervention)

    Is there a correlation of the highest degree of school education of the parents with emotional and knowledge outcomes of the children

  4. Profession of the parents

    Time frame: Baseline (before the intervention)

    Is there a correlation of the profession of the parents with emotional and knowledge outcomes of the children

  5. Financial standing of the parents

    Time frame: Baseline (before the intervention)

    Is there a correlation of the financial standing of the parents with emotional and knowledge outcomes of the children

  6. Housing conditions of the family

    Time frame: Baseline (before the intervention)

    Is there a correlation of the housing condition of the family with emotional and knowledge outcomes of the children

  7. Psychological or physical illness in the family

    Time frame: Baseline (before the intervention)

    Is there a correlation of the psychological or physical burden in the family with emotional and knowledge outcomes of the children

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: CARTOON

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2021
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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