NCT04845243

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

April 8, 2021

Last Update Submit

April 13, 2021

Conditions

Keywords

Autism Spectrum DisorderEmotion recognition training

Outcome Measures

Primary Outcomes (4)

  • Change in performance accuracy in Geneva Emotion Recognition Test (GERT)

    Percentage of accuracy to stimuli showing facial emotions

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

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

    Response times to stimuli showing facial emotions

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

  • Change in performance reaction times in Social decision-making task

    Reaction times for each of the facial emotions shown

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

  • Change in choices in Social decision-making task

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

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

Study Arms (1)

Emotion recognition training

OTHER

All 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.

Behavioral: Emotionen Verstehen und Ausdrücken (E.V.A.)

Interventions

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.

Emotion recognition training

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (16)

  • 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.

    PMID: 26340451BACKGROUND
  • Blakemore SJ. The social brain in adolescence. Nat Rev Neurosci. 2008 Apr;9(4):267-77. doi: 10.1038/nrn2353.

    PMID: 18354399BACKGROUND
  • 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.

    PMID: 20167473BACKGROUND
  • 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.

    PMID: 24150885BACKGROUND
  • 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.

    PMID: 31520245BACKGROUND
  • 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.

    PMID: 22494084BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 11708589BACKGROUND
  • 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/

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32713184BACKGROUND
  • 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.

    PMID: 32997168BACKGROUND
  • 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.

    PMID: 22703720BACKGROUND
  • 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.

    PMID: 26121148BACKGROUND
  • 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

    BACKGROUND
  • Schlegel K, Grandjean D, Scherer KR. Introducing the Geneva emotion recognition test: an example of Rasch-based test development. Psychol Assess. 2014 Jun;26(2):666-72. doi: 10.1037/a0035246. Epub 2013 Dec 2.

    PMID: 24295238BACKGROUND

MeSH Terms

Conditions

Autism Spectrum DisorderConduct Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersAttention Deficit and Disruptive Behavior Disorders

Central Study Contacts

Christina Stadler, Professor

CONTACT

Ana Cubillo, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
NETWORK
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head Psychologist, Clinical Professor, Clinic for Children and Adolescents

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 14, 2021

Study Start

April 15, 2021

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

April 14, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share