Trial document



drksid header

  DRKS00009337

Trial Description

start of 1:1-Block title

Title

Zirkus Empathico – Promoting socioemotional competencies in 5- to 10-year-old children with autism spectrum conditions using a computer-based training program

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

Zirkus Empathico

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.zirkus-empathico.de/

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The greater aim of the research project is to study the effectiveness of a computer-based intervention promoting cognitive and emotional empathy as well as the basic identification of experienced emotions in 5- to 10-year-old children with autism spectrum disorder.

According to the current state of research, these competencies are less developed in people with autism spectrum conditions. Therefore promoting these competencies is highly relevant allowing for advantages in social behavior and the consequent social integration of affected people.

In order to study the effectiveness of the computer-based training, an adult caretaker will train as a tutor for 6 weeks with the child and the mobile application “Zirkus Empathico". (The former 8-weeks training period was reduced to 6 weeks on 27/01/2016 in order to keep the participant`s motivation, because the first participants worked through the training modules faster than expected).


The training focusses on the differentiation of own emotions (module 1), emotion recognition using facial expression (module 2) and contextual clues (module 3) and empathic feeling and reacting (module 4). The 5th modules aims at the generalization of the acquired skills into everyday life.

At pre- and post-examinations (T2 and Follow-up) the child’s socioemotional competencies will be assessed using parent questionnaires, (kindergarten-) teacher questionnaires, and behavioral measures. The outcomes of the training condition will be compared to those of a control group of autistic children. The control group will play several educational online games together with an adult caretaker in order to foster their confidence in themselves and their environment.

In comparison to the control group, an increase in the basal ability to differentiate their own emotions, the ability to recognize the emotional state of others (cognitive empathy) and the feeling with others (emotional empathy) within the training group. The actual social behavior is ought to be enhanced long lastingly by the holistic nature of the promotion.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

For the randomized-controlled study with 82 children diagnosed with autism spectrum disorder, it is expected, that the six week computer-based and tutor-guided training using the app “Zirkus Empathico” results in an increase in cognitive empathy (measured by the emotion recognition test KERMIT), and an increase in emotional empathy (measured by the parent questionnaire GEM) as compared to a training teaching non-social skills.

Additionally, a better performance in the differentiation of own emotions, and an increase in their well-being as reported by the children and their parents is expected.

The effects of the training in the primary measures GEM and KERMIT will be found immediately after the intervention, as well as in a follow-up examination, executed three month later.

Minimization with a randomization ratio of 0.8 and 2 stratification factors (verbal age (3 level); study center (3 level)) is chosen as a randomization procedure and will be performed using the software
MinimPy (http://minimpy.sourceforge.net).



In conducting a power analyses with the software G*Power, the required sample size was estimated according to the reported effect sizes of previous studies targeting computer-based training of emotion recognition skills in children (Grynszpan, Weiss, Perez- Diaz & Gall, 2014). At the time of the study registration, the power analyses was based on an ANOVA. Due to methodological considerations, we decided to base the calculation on a t-test at T2 instead, thus we conducted a second power analyses. With an assumed power of 0.8, the effect size d = 0.58 and an assumed drop-out rate of 7%, 82 subjects are required. Accordingly, the registration was changed the 28th of July 16.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00009337
  •   2015/12/03
  •   [---]*
  •   yes
  •   Approved
  •   2015-18, Ethikkommission der Lebenswissenschaftlichen Fakultät der Humboldt-Universität zu Berlin
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1175-5451 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F84 -  Pervasive developmental disorders
  •   autism/Asperger-Syndrom/pervasive developmental disorder, not otherwise specified (PDD-NOS)/autism spectrum disorder
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Treatment group (TG) - 5 to 10 year old children with the diagnosis autism/Asperger-Syndrom/pervasive developmental disorder, not otherwise specified (PDD-NOS)/autism spectrum disorder receive an empathy training with the mobile application "Zirkus Empathico" (http://www.zirkus-empathico.de/; see publication for further information). An adult caretaker will train as a tutor for 6 weeks with the child and the app in their everyday environment. The training consists of 100min training per week with the 5 training modules of the app (1: Differentiation of own emotions, 2+3: Emotion recognition based on facial expression and situative context, 4: Empathic feeling and reacting, 5: Generalization). Additionally, the training content will be generalized for 10min per day into everyday life using the 5th training module. The tutor receives weekly supervision via phone and a training manual with information about the realization of the training.
  •   Control group (CG) - 5 to 10 year old children with the diagnosis autism/Asperger-Syndrom/pervasive developmental disorder, not otherwise specified (PDD-NOS)/autism spectrum disorder receive online educational games with non-social content for their free choice (http://www.ampelini.de/; http://www.unserkoerper.de/, http://www.pedalpiraten.de/startseite.html; http://www.klingklangland.com/index.html; http://www.multiverso.de/game/; http://www.lernspass-fuer-kinder.de/; http://www.isungur.de/). An adult caretaker will play the games with the child for 100min per week over 6 weeks in their everyday environment. The caretaker receives weekly supervision via phone and a training manual.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

1. Training component emotional empathy: Griffith Empathy Measure – GEM; German adaption (Dadds, et al., 2008, Greimel, Schulte-Rüther, Kamp-Becker, Remschmidt, Herpertz-Dahlmann, & Konrad, 2011). The parent questionnaire GEM measures in 23 items mostly the emotional empathy of children and teenagers.

2. Training component cognitive empathy:
The computer-based emotion recognition test KERMIT (Kids Emotion Recognition Multiple Images Task, Drimalla, Kirst & Dziobek, in prep.) measures the emotion recognition accuracy and speed using photographies of basic emotions.

Both instruments will be used in the pre- (T1) and post-assessment (T2, after 6 weeks training) as well as in the 3-month-follow-up.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

3. Social responsivness scale – SRS (Bölte & Poustka, 2007), subscales social conciousness/cognition, social motivation. Parent questionnaire, filled in by (a) a parent and (b) a (kindergarten) teacher: Generalization of the intervention on daily social behavior.

4. 24 computer-presented fotographies of 6 basic emotions (Ekman & Friesen, 1976): Generalization of emotion recognition skills to non-trained stimuli.

5. Level of emotional awareness scale for children – LEAS-C (Bajgar, Ciarrochi, Lane, & Deane, 2005). Performance-based assessment with 12 evocative interpersonal scenarios: Structure and complexity of emotional awareness in self and others.

6. Multifaceted Empathy Test für Jugendliche/Kinder – MET-J/K (Poustka, Rehm, Holtmann, Bock, Böhmert, & Dziobek, 2010). Fotobased test to measure emotional empathy.

7. The Emotion Regulation Checklist (ERC; Shields & Cicchetti) Parent questionnaire: Changes in the child`s emotion regulation competencies.

8. The Inventory of Callous-Unemotional Traits (ICU,
Essau, Sasagawa, & Frick, 2006). Parent questionnaire: Changes in callous-unemotional bahaviour.

9. Kiddy Kindl (Ravens-Sieberer, Görtler, Bullinger 2000). Parent questionnaire: Changes in health-related quality of life.

The instruments 3-9 will be included in the pre- (T1) and post-assessment (T2, after 6 weeks training) as well as in the 3-month-follow-up.

10. Goal Attainment Scaling GAS (Kiresuk & Sherman, 1968). Operationalisation of 2 by the parents individually defined training goals concerning socioemotional competencies. The GAS will be used in T1 and T2 (after 6 weeks training).

11. Qualitative evaluation questionnaire (Kirst et al.): Qualitative evaluation of the intervention by parents and children: Generalization of socioemotional competencies, practicability, subjective perceived changes, influences on the family`s situation. The evaluation will be included in the post-assessment (T2, after 6 weeks training) and in a reduced form in the 3-month-follow-up.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Austria
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
  • other 
  • Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/12/05
  •   82
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   5   Years
  •   10   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Clinical diagnosis (ICD 10/DSM 5) Asperger-Syndrom / Kanner Autism / Pervasive developmental disorder, not otherwise specified (PDD-NOS) / autism spectrum disorder; chronological age: 5 – 10 years 11 month at the start of the training; no or stable psychopharmacotherapy

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

nonverbal IQ <=70 (Coloured progressive matrices intelligence test. Raven, Bulheller & Häcker, 2001)
non-sufficient level of receptive language (verbal age < 5;0 Jahre; Peabody Picture Vocabulary Test - Revision 4, German Adaption. Lenhard, Lenhard, Segerer & Suggate, 2015); psychopathological comorbidity (schizophrenia, bipolar disorder, social phobia,major depression with suicidal intentions, personality disorder), severe aggressive/autoaggressive behaviour which may hamper the training massively; neurological disorder
(exception: well-treated epilepsy); other disorders/illnesses which may hamper the intervention; parallel participation in group-based social competence training; parallel participation in other clinical studies.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Humboldt-Universität Berlin
    • Ms.  Prof. Dr.  Isabel  Dziobek 
    • Unter den Linden 6
    • 10999  Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Medizinische Universität Wien / Universitätsklinik für Kinder- und Jugendpsychiatrie
    • Ms.  Prof. Dr.med.  Luise  Poustka 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Klinik für Kinder- und Jugendpsychiatrie und Psychotherapie der KJPP Augsburg / Josefinum
    • Ms.  Prof. Dr. med.  Michele  Noterdaeme 
    • Kapellenstrasse 30
    • 86154  Augsburg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Humboldt-Universität zu Berlin
    • Ms.  Prof. Dr.  Isabel  Dziobek 
    • Unter den Linden 6
    • 10999  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Humboldt-Universität zu Berlin
    • Ms.  Simone  Kirst 
    • Unter den Linden 6
    • 10999  Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Humboldt- Universität zu Berlin
    • Ms.  Prof. Dr.  Isabel  Dziobek 
    • Unter den Linden 6
    • 10999  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2018/04/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.