App-based Training Study Employing the Computer-based Program Zirkus Empathico: Analysis of Behavioral and Neural Correlates of Socio-Emotional Competences in Four-to Six-Year-Old Children
Organizational Data
- DRKS-ID:
- DRKS00015789
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2018-10-24
- Last update in DRKS:
- 2023-08-14
- Registration type:
- Prospective
Acronym/abbreviation of the study
Zirkus Empathico 2
URL of the study
http://www.zirkus-empathico.de/
Brief summary in lay language
Psychological and psychosomatic diseases in childhood and adolescence play an increasing role in Germany. First indicators for dysfunctional, psychological behavioral pattern can be found in deficits of socio-emotional competences. Fostering of these competences supports the development of personal and social resources, which are important pillars to handle stressful life circumstances and their negative consequences. This study examines whether socio-emotional competences can be effectively fostered with the computer-based program Zirkus Empathico. Its efficiency is evaluated by investigating empathy as primary outcome and emotion knowledge as well as prosocial behavior as secondary outcomes with questionnaires and brain waves collected through electroencephalography (EEG). The study design includes a training group, which receives the Zirkus Empathico training, and an active control group which receives the Squirrel & Bär training to foster English language competences. Participants are randomly assigned to the groups. Questionnaires are filled in before and after the training. Between these measurements, families receive a tablet computer with which their children can play with one of the training programs. Children practice under the guidance of one parent for six weeks, one hour per week. Zirkus Empathico comprises exercises for emotion detection in emotional facial expression and contextual videos as well as exercises for empathy. Within the Squirrel & Bär application, children get in touch with the English language, including learning first words and grammatical rules. It is expected that the training group improves in empathy, emotion knowledge, and prosocial behavior in comparison to the control group. In addition, it is assumed that the EEG components are influenced by participating in the Zirkus Empathico training.
Brief summary in scientific language
To interact successfully with others is positively correlated with life satisfaction, health and academic success. Socio-emotional competences are important personal and social resilience factors which contribute to handle stressful life circumstances and their negative consequences effectively. Though their significance has been shown, first deficits are already apparent within childhood. This longitudinal study therefore aims at investigating the efficiency of the tablet-based training Zirkus Empathico to foster these competences in children aged four to six years. Measures for empathy as primary outcome and emotion knowledge as well as prosocial behavior as secondary outcomes are assessed before and after the training. Socio-emotional competences are examined with questionnaires (GEM, EMK 3-6, SDQ), behavioral assessments (EMK 3-6) and electroencephalographic (EEG) measures. The study examines whether (1) participants of the training group show increased values of empathy, emotion knowledge and prosocial behavior in comparison to participants of the control group and (2) whether amplitudes of the event-related components (ERPs) of early sensory processing (P1, N170) and late processing (P300) are modulated by participating in the training. Behavioral correlates are measured in a pre/posttest design with one training group and one active control group. The measurement of EEG correlates is carried out at posttest only. The training group receives the Zirkus Empathico training to foster socio-emotional competences. The active control group receives the application Squirell & Bär to practice their knowledge of the English knowledge. The training with one of the programs is executed over a period of six weeks (two times per week for 30 minutes) under parental supervision. Participants are assigned randomly to the groups. Potential developmental effects are controlled with covariate-adaptive randomization and the minimization procedure. The randomization ratio is 0.7 with two stratifying variables (age [two factors], gender [two factors], software MinimPy: [http://minimpy.sourceforge.net]. The estimation of sample size was conducted with the software G*Power. With regard to previous studies of computer-based training of emotion knowledge in children (e.g. Grynszpan et al., 2014), a small effect was assumed. In addition, a repeated-measures ANOVA with the parameters group (two factors) and time (two factors) was used (α = 0.05, Power = 0.80, correlation between time points of the primary outcome GEM: 0.69 [Neumann et al., 2014]). In total, a number of 31 participants per group is needed (total sample size: 62 participants). Additionally, a drop-out rate of 20 % was assumed (based on attrition rates of former studies with children within this age range). Consequently, 74 participants will be collected.
Health condition or problem studied
- ICD10:
- F93 - Emotional disorders with onset specific to childhood
- ICD10:
- F98 - Other behavioural and emotional disorders with onset usually occurring in childhood and adolescence
- ICD10:
- F91 - Conduct disorders
- ICD10:
- F92 - Mixed disorders of conduct and emotions
- ICD10:
- F93 - Emotional disorders with onset specific to childhood
- ICD10:
- F94 - Disorders of social functioning with onset specific to childhood and adolescence
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- Training group (TG) – Training of socio-emotional competences with the help of the computer-based program Zirkus Empathico (http://www.zirkus-empathico.de/). The training lasts 6 weeks for 60 minutes per week and is administered at home under parental supervision. In addition, the family receives a training manual which informs about all aspects of the training and tablet computer.
- Arm 2:
- Active control group (CG): Training of the English language with the help of the mobile app Squirrel & Bär (http://squirrel-baer.de/). The training lasts 6 weeks for 60 minutes per week and is administered at home under parental supervision. In addition, the family receives a training manual which informs about all aspects of the training and the tablet computer.
Endpoints
- Primary outcome:
- 1. Training component: Empathy •Empathy is measured from the parental perspective with the help of the Griffith Empathy Measure (GEM; Dadds, et al., 2008, Greimel et al., 2011) and the sub-test empathy of the Inventar zur Erfassung emotionaler Kompetenzen bei Drei- bis Sechsjährigen (EMK 3-6; Petermann & Gust, 2016) from the perspective of the parents and the child. •The parental questionnaire GEM examines empathy with 23 items. The EMK 3-6 screening questionnaire contains of four items for empathy. The EMK 3-6 behavioral assessment uses dolls to present the child with different child-typical situations. The child then describes what the doll thinks and feels in this moment. •GEM and EMK 3-6 are administered at first (T1) and second (T2) measurement.
- Secondary outcome:
- 2. Training component: Emotion knowledge •EMK 3-6 from the parental perspective: sub-test emotion knowledge, from child’s perspective: sub-test primary emotions •Results of the EEG measurement after training completion, with special regard to the differentiation of emotion within the ERPs; collected from child’s perspective 3. Training component: Prosocial behavior •Strength and Difficulties Questionnaire (SDQ; Goodman, 1997), measurement of behavioral disruptions, emotional problems, hyperactivity, problems with peers and prosocial behavior, from parental perspective •EMK 3-6 sub-test: prosocial behavior, from child’s perspective •EMK 3-6 and SDQ are collected during first (T1) and second measurement (T2) after the training period. EEG collection is administered at T2 only.
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Humboldt-Universität zu Berlin Berlin
Recruitment period and number of participants
- Planned study start date:
- 2018-10-29
- Actual study start date:
- 2018-10-29
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2020-07-02
- Target Sample Size:
- 74
- Final Sample Size:
- 74
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 4 Years
- Maximum Age:
- 6 Years
- Additional Inclusion Criteria:
- German as native language, no bilingualism (English)
Exclusion Criteria
•Nonverbal IQ <=70 (Coloured progressive matrices intelligence test; Raven, Bulheller & Häcker, 2001) •Inadequate understanding of language (verbal age < 4;0 years; Peabody Picture Vocabulary Test; Lenhard et al., 2015) •Neurological or psychological disorders •Other training- or EEG-impairing disorders/medication/illnesses •Parallel participation in other socio-emotional trainings •Parallel participation in other clinical trials
Addresses
Primary Sponsor
- Address:
- Humboldt-Universität zu BerlinUnter den Linden 610099 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Berlin School of Mind and BrainHumboldt-Universität zu BerlinSandra NaumannLuisenstraße 5610117 BerlinGermany
- Telephone:
- 030/20931740
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Berlin School of Mind and BrainHumboldt-Universität zu BerlinSandra NaumannLuisenstraße 5610117 BerlinGermany
- Telephone:
- 0176/76867649
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Berlin School of Mind and BrainHumboldt-Universität zu BerlinSandra NaumannLuisenstraße 5610117 BerlinGermany
- Telephone:
- 030/20931740
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Humboldt-Universität zu BerlinUnter den Linden 610099 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission des Instituts für Psychologie, Humboldt-Universität zu Berlin, Lebenswissenschaftliche FakultätUnter den Linden 610099 BerlinGermany
- Telephone:
- +49 3020936775
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2018-02-23
- Ethics committee number:
- ZE2018-06
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2018-03-30
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- https://osf.io/vzgtb/
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- DRKS00009337 - Zirkus Empathico - Förderung sozioemotionaler Kompetenzen bei fünf- bis zehnjährigen Kindern im Autismus-Spektrum anhand eines computerbasierten Trainingsprogramms
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Naumann, S., Bayer, M., Kirst, S., van der Meer, E. & Dziobek, I. (2023). A randomized controlled trial on the digital socio-emotional competence training Zirkus Empathico for preschoolers. npj Science of Learning. 8, 20. https://doi.org/10.1038/s41539-023-00169-8
- Date of first publication of study results:
- 2023-06-19
- DRKS entry published for the first time with results:
- 2023-08-14
Basic reporting
- Basic Reporting / Results tables:
- Naumann, S., Bayer, M., Kirst, S., van der Meer, E. & Dziobek, I. (2023). A randomized controlled trial on the digital socio-emotional competence training Zirkus Empathico for preschoolers. npj Science of Learning. 8, 20. https://doi.org/10.1038/s41539-023-00169-8
- Brief summary of results:
- In this randomized controlled trial (RCT), the digital socio-emotional competence training Zirkus Empathico was tested in 74 Central European children (5.1 (0.9) years; 34 females) within a longitudinal design (three time points: T1 = pre-training; T2 = immediately following 6-week training, T3 = 3-month follow-up). The pre-registered primary outcome was empathy, secondary outcomes included emotion recognition, prosocial behavior, and behavioral problem reduction; furthermore, children’s neural sensitivity to facial expressions quantified with event-related potentials. Compared to controls (N = 38), Zirkus Empathico participants (N = 36) showed increases in empathy (d = 0.28 [−0.17, 0.76]), emotion recognition (d = 0.57 [0.01, 1.06]), prosocial behavior (d = 0.51 [0.05, 0.99]) and reduced behavioral problems (d = 0.54 [0.08, 1.03]). They also showed larger P3 amplitudes to happy vs. angry and neutral facial expressions post-training. Thus, Zirkus Empathico may be a promising digital training for social competence in preschoolers.