Effectiveness of a Short Computer-based Emotion Recognition Training in Different Patient Groups
Primary Purpose
Autism Spectrum Disorder, Conduct Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Emotionen Verstehen und Ausdrücken (E.V.A.)
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Emotion recognition training
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Emotion recognition training
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in performance accuracy in Geneva Emotion Recognition Test (GERT)
Percentage of accuracy to stimuli showing facial emotions
Change in performance response times in Geneva Emotion Recognition Test (GERT)
Response times to stimuli showing facial emotions
Change in performance reaction times in Social decision-making task
Reaction times for each of the facial emotions shown
Change in choices in Social decision-making task
The proportion of choices that maximise their self-gain for each of the facial emotions shown
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04845243
Brief Title
Effectiveness of a Short Computer-based Emotion Recognition Training in Different Patient Groups
Official Title
Compared Effectiveness of a Short Computer-based Emotion Recognition Training in Conduct Disorder and Autistic Spectrum Disorder Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2021 (Anticipated)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Christina Stadler
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Conduct Disorder
Keywords
Autism Spectrum Disorder, Emotion recognition training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Emotion recognition training
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Emotionen Verstehen und Ausdrücken (E.V.A.)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in performance accuracy in Geneva Emotion Recognition Test (GERT)
Description
Percentage of accuracy to stimuli showing facial emotions
Time Frame
Change in performance before and after the emotion recognition training, after 1 month (pre/post measure)
Title
Change in performance response times in Geneva Emotion Recognition Test (GERT)
Description
Response times to stimuli showing facial emotions
Time Frame
Change in performance before and after the emotion recognition training, after 1 month (pre/post measure)
Title
Change in performance reaction times in Social decision-making task
Description
Reaction times for each of the facial emotions shown
Time Frame
Change in Performance before and after the emotion recognition training, after 1 month (pre/post measure)
Title
Change in choices in Social decision-making task
Description
The proportion of choices that maximise their self-gain for each of the facial emotions shown
Time Frame
Change in choices before and after the emotion recognition training, after 1 month (pre/post measure)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Stadler, Professor
Phone
+41 61 325 51 11
Email
Christina.stadler@upk.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Cubillo, PhD
Phone
+41 61 325 80 33
Email
Ana.cubillo@upk.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Effectiveness of a Short Computer-based Emotion Recognition Training in Different Patient Groups
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