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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
Prof. Christina Stadler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Emotion recognition training

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 8, 2021
    Last Updated
    April 13, 2021
    Sponsor
    Prof. Christina Stadler
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    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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    26340451
    Citation
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