- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04845243
Effectiveness of a Short Computer-based Emotion Recognition Training in Different Patient Groups
April 13, 2021 updated by: Prof. Christina Stadler
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christina Stadler, Professor
- Phone Number: +41 61 325 51 11
- Email: Christina.stadler@upk.ch
Study Contact Backup
- Name: Ana Cubillo, PhD
- Phone Number: +41 61 325 80 33
- Email: Ana.cubillo@upk.ch
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis: ASD or CD
- German speaking
- IQ > 70
- Age: 10-18
Exclusion Criteria:
- Comorbid Anxiety or Depressive disorder diagnosis
- IQ < 70
- Insufficient German language skills
- Severe developmental disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Emotion recognition training
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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)
Time Frame: Change in performance before and after the emotion recognition training, after 1 month (pre/post measure)
|
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
Time Frame: Change in Performance before and after the emotion recognition training, after 1 month (pre/post measure)
|
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
Time Frame: Change in choices before and after the emotion recognition training, after 1 month (pre/post measure)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Blakemore SJ. The social brain in adolescence. Nat Rev Neurosci. 2008 Apr;9(4):267-77. doi: 10.1038/nrn2353.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 15, 2021
Primary Completion (Anticipated)
November 30, 2021
Study Completion (Anticipated)
November 30, 2021
Study Registration Dates
First Submitted
April 8, 2021
First Submitted That Met QC Criteria
April 13, 2021
First Posted (Actual)
April 14, 2021
Study Record Updates
Last Update Posted (Actual)
April 14, 2021
Last Update Submitted That Met QC Criteria
April 13, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EmoRecTraining_EVA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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