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AzTrials

Autism Spectrum DisorderNCT04845243

Effectiveness of a Short Computer-based Emotion Recognition Training in Different Patient Groups

A study testing Emotionen Verstehen und Ausdrücken (E.V.A.) in people with Autism Spectrum Disorder and Conduct Disorder, run by Prof. Christina Stadler.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Emotion recognition and regulation are necessary skills for social interaction. Disrupted development of these processes severely interferes with socio-emotional development. These difficulties are commonly reported in patients with Autistic Spectrum Disorder (ASD) or Conduct Disorder (CD), with the subsequent… Read more about this study

Who is it for?
Ages 10 to 18 years
Conditions the study is for
Autism Spectrum Disorder, Conduct Disorder
What is being tested?
Emotionen Verstehen und Ausdrücken (E.V.A.)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
15 Apr 2021to 30 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Diagnosis: ASD or CD
  • German speaking
  • IQ > 70
  • Age: 10-18

Who cannot join

  • Comorbid Anxiety or Depressive disorder diagnosis
  • IQ < 70
  • Insufficient German language skills
  • Severe developmental disorders

Trial locations and contacts

No sites are listed yet.

Christina Stadler, Professor contact

+41 61 325 51 11

Christina.stadler@upk.ch

Ana Cubillo, PhD contact

+41 61 325 80 33

Ana.cubillo@upk.ch

About this study

Official title: Compared Effectiveness of a Short Computer-based Emotion Recognition Training in Conduct Disorder and Autistic Spectrum Disorder Patients

Emotion recognition and regulation are necessary skills for social interaction. Disrupted development of these processes severely interferes with socio-emotional development. These difficulties are commonly reported in patients with Autistic Spectrum Disorder (ASD) or Conduct Disorder (CD), with the subsequent social/interpersonal difficulties. The available evidence suggest that impaired emotion regulation processes might underlie the aggressive behaviours frequently observed in both disorders. However, no study has yet investigated the presence of disorder-specific characteristics on emotion processing between these two disorders. Different impaired emotion recognition difficulties may underlie the reported emotion dysregulation. A practical implication of this is that given that both disorders have shown difficulties during emotion recognition processes, a short, computer-based intervention to improve emotion recognition might benefit both cases, even though their aetiologies might differ.

Read the detailed description

For ASD patients, studies training facial emotion recognition have focused on increasing the active attention to the eye region, re-directing attention to facial features to facilitate facial emotion recognition. Evidence shows positive results using computer-based emotion recognition training programs with young children and adolescents with ASD. It has also been recently suggested that emotion recognition training may be a suitable intervention for patients with CD. This would be supported by some preliminary evidence in patients with severe behavioural problems, young offenders and patients with CD + CU Traits. The overall goal of this project is to investigate the compared impact of an emotion recognition training in patients with ASD or CD. This goal can be subdivided into three separate subgoals: a) identify whether the training program is effective; b) identify whether the training program has differentiated or comparable effects between both patients groups and c) investigate individual characteristics that may help identify those individuals who would benefit most from the intervention. This information is crucial to inform the design of more efficient treatments to differentially address the specific deficits associated to the disorders.

Being tested
Emotionen Verstehen und Ausdrücken (E.V.A.)
Keywords
Autism Spectrum Disorder, Emotion recognition training
Medical subject headings
Autism Spectrum Disorder, Conduct Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotionen Verstehen und Ausdrücken (E.V.A.)Behavioural

    The online training is focused on the strengthening of socioemotional competences and consists of different training tasks (up to 3 million) presented to the participant as mini games. These training tasks are specifically designed according to empirical findings to match the socio-emotional recognition needs of people with ASD. During these games, an adapted Elo-Algorithm allows to automatically evaluate the participants' performance and adapts the difficulty levels throughout the users' progress in the training.

Study groups in NCT04845243
Study groupRoleWhat they receive
Emotion recognition trainingOtherAll participants have to complete the online emotion recognition training E.V.A. as well as the pre- and post training tasks: GERT and social decision making task.
Receives: Behavioral: Emotionen Verstehen und Ausdrücken (E.V.A.)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in performance accuracy in Geneva Emotion Recognition Test (GERT)

    Percentage of accuracy to stimuli showing facial emotions

    Measured: Change in performance before and after the emotion recognition training, after 1 month (pre/post measure)

  2. Change in performance response times in Geneva Emotion Recognition Test (GERT)

    Response times to stimuli showing facial emotions

    Measured: Change in performance before and after the emotion recognition training, after 1 month (pre/post measure)

  3. Change in performance reaction times in Social decision-making task

    Reaction times for each of the facial emotions shown

    Measured: Change in Performance before and after the emotion recognition training, after 1 month (pre/post measure)

  4. Change in choices in Social decision-making task

    The proportion of choices that maximise their self-gain for each of the facial emotions shown

    Measured: Change in choices before and after the emotion recognition training, after 1 month (pre/post measure)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2021
  2. Study start15 Apr 2021 (estimated)
  3. Primary completion30 Nov 2021 (estimated)
  4. Study completion30 Nov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Participants will receive six sessions (duration approx. 1h/session) of the software-based training program "Emotionen Verstehen und Ausdrücken" (EVA; Moebert \& Lucke, 2019). Sessions will be administered 2-3 times/week depending on the participants' time availability. In order to objectively identify the potential benefit of the training for each participant, they will perform two separate tasks before and after the emotion recognition training, the Geneva Emotion Recognition test (GERT; Schlegel, Grandjean,\& Scherer, 2014) and a social decision-making task. A comparison of their performance pre- and post-training is taken as an indicator of improvement in emotion recognition skills.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04845243
Sponsor's protocol ID
EmoRecTraining_EVA
Status last verified
Apr 2021
First submitted
8 Apr 2021
Last updated
14 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ahmed SP, Bittencourt-Hewitt A, Sebastian CL. Neurocognitive bases of emotion regulation development in adolescence. Dev Cogn Neurosci. 2015 Oct;15:11-25. doi: 10.1016/j.dcn.2015.07.006. Epub 2015 Jul 29.

    PubMed 26340451

  • Blakemore SJ. The social brain in adolescence. Nat Rev Neurosci. 2008 Apr;9(4):267-77. doi: 10.1038/nrn2353.

    PubMed 18354399

  • Somerville LH, Casey BJ. Developmental neurobiology of cognitive control and motivational systems. Curr Opin Neurobiol. 2010 Apr;20(2):236-41. doi: 10.1016/j.conb.2010.01.006. Epub 2010 Feb 16.

    PubMed 20167473

  • Tanaka JW, Sung A. The "Eye Avoidance" Hypothesis of Autism Face Processing. J Autism Dev Disord. 2016 May;46(5):1538-52. doi: 10.1007/s10803-013-1976-7.

    PubMed 24150885

  • Wieckowski AT, White SW. Attention Modification to Attenuate Facial Emotion Recognition Deficits in Children with Autism: A Pilot Study. J Autism Dev Disord. 2020 Jan;50(1):30-41. doi: 10.1007/s10803-019-04223-6.

    PubMed 31520245

  • Ramdoss S, Machalicek W, Rispoli M, Mulloy A, Lang R, O'Reilly M. Computer-based interventions to improve social and emotional skills in individuals with autism spectrum disorders: a systematic review. Dev Neurorehabil. 2012;15(2):119-35. doi: 10.3109/17518423.2011.651655.

    PubMed 22494084

  • Kouo JL, Egel AL. The Effectiveness of Interventions in Teaching Emotion Recognition to Children with Autism Spectrum Disorder. Rev J Autism Dev Disord. 2016 Sep;3(3):254-65.

  • Silver M, Oakes P. Evaluation of a new computer intervention to teach people with autism or Asperger syndrome to recognize and predict emotions in others. Autism. 2001 Sep;5(3):299-316. doi: 10.1177/1362361301005003007.

    PubMed 11708589

  • Zoerner D, Schutze J, Kirst S, Dziobek I, Lucke U. Zirkus Empathico: Mobile Training of Socio-Emotional Competences for Children with Autism. In: 2016 IEEE 16th International Conference on Advanced Learning Technologies (ICALT) [Internet]. Austin, TX, USA: IEEE; 2016 [cited 2021 Feb 10]. p. 448-52. Available from: http://ieeexplore.ieee.org/document/7757020/

  • Hunnikin LM, van Goozen SHM. How can we use knowledge about the neurobiology of emotion recognition in practice? Journal of Criminal Justice. 2019 Nov;65:101537.

  • Cooper S, Hobson CW, van Goozen SH. Facial emotion recognition in children with externalising behaviours: A systematic review. Clin Child Psychol Psychiatry. 2020 Oct;25(4):1068-1085. doi: 10.1177/1359104520945390. Epub 2020 Jul 25.

    PubMed 32713184

  • Wells AE, Hunnikin LM, Ash DP, van Goozen SHM. Improving emotion recognition is associated with subsequent mental health and well-being in children with severe behavioural problems. Eur Child Adolesc Psychiatry. 2021 Nov;30(11):1769-1777. doi: 10.1007/s00787-020-01652-y. Epub 2020 Sep 30.

    PubMed 32997168

  • Dadds MR, Cauchi AJ, Wimalaweera S, Hawes DJ, Brennan J. Outcomes, moderators, and mediators of empathic-emotion recognition training for complex conduct problems in childhood. Psychiatry Res. 2012 Oct 30;199(3):201-7. doi: 10.1016/j.psychres.2012.04.033. Epub 2012 Jun 15.

    PubMed 22703720

  • Hubble K, Bowen KL, Moore SC, van Goozen SH. Improving Negative Emotion Recognition in Young Offenders Reduces Subsequent Crime. PLoS One. 2015 Jun 29;10(6):e0132035. doi: 10.1371/journal.pone.0132035. eCollection 2015.

    PubMed 26121148

  • Moebert, T. & Lucke, U., (2019). E.V.A. - Emotionen Verstehen und Ausdrücken. In: Pinkwart, N. & Konert, J. (Hrsg.), DELFI 2019. Bonn: Gesellschaft für Informatik e.V.. (S. 289-290). DOI: 10.18420/delfi2019_324

Questions about this trial

What is this clinical trial studying?

A study testing Emotionen Verstehen und Ausdrücken (E.V.A.) in people with Autism Spectrum Disorder and Conduct Disorder, run by Prof. Christina Stadler.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Christina Stadler, Professor (+41 61 325 51 11, Christina.stadler@upk.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in performance accuracy in Geneva Emotion Recognition Test (GERT) (time frame: Change in performance before and after the emotion recognition training, after 1 month (pre/post measure)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04845243, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.

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