NCT04724616

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2021

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2023

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

January 10, 2021

Last Update Submit

January 12, 2024

Conditions

Keywords

Educational Programeducation

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (7)

  • Nationality of parents

    Baseline (before the intervention)

  • First language of parents

    Baseline (before the intervention)

  • Highest degree of school education

    Baseline (before the intervention)

  • Profession of the parents

    Baseline (before the intervention)

  • Financial standing of the parents

    Baseline (before the intervention)

  • +2 more secondary outcomes

Study Arms (2)

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.

Other: Educational Program (CARTOON)

Interventions

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.

Also known as: Education, Psycho-educational intervention
Intervention Group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children between three and six years who are attending kindergarten
  • consent of the parents and the participants

You may not qualify if:

  • physically unable to complete any of the training exercises
  • German skills not good enough to follow the instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1020, Austria

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19Neurodevelopmental DisordersStress, Psychological

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Philipp Steinbauer, Dr.

    Comprehensive Center For Pediatrics, Division of Neonatology, Intensive Care Medicine and Neuropediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 10, 2021

First Posted

January 26, 2021

Study Start

January 6, 2021

Primary Completion

January 12, 2023

Study Completion

January 12, 2023

Last Updated

January 16, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations