Clinical trial NCT04724616: CARTOON: CoronAviRus (COVID-19) educaTional prOgram fOr childreN
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
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Pediatric Psychiatric Disorder
Psychological Stress
Keywords: Educational Program
education
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 57
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Change of Emotional Outcome
timeFrame: Baseline (before the intervention), 1 day after the intervention and three months after the intervention
measure: Change of Knowledge Outcome
timeFrame: Baseline (before the intervention), 1 day after the intervention and three months after the intervention
measure: Baseline Behavior of the Participants
timeFrame: Baseline (before the intervention)
Secondary outcomes:
measure: Nationality of parents
timeFrame: Baseline (before the intervention)
measure: First language of parents
timeFrame: Baseline (before the intervention)
measure: Highest degree of school education
timeFrame: Baseline (before the intervention)
measure: Profession of the parents
timeFrame: Baseline (before the intervention)
measure: Financial standing of the parents
timeFrame: Baseline (before the intervention)
measure: Housing conditions of the family
timeFrame: Baseline (before the intervention)
measure: Psychological or physical illness in the family
timeFrame: Baseline (before the intervention)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Comprehensive Center For Pediatrics, Division of Neonatology, Intensive Care Medicine and Neuropediatrics
name: Philipp Steinbauer, Dr.
role: PRINCIPAL_INVESTIGATOR
References: