- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04845243
Effectiveness of a Short Computer-based Emotion Recognition Training in Different Patient Groups
13 aprile 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Anticipato)
80
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Christina Stadler, Professor
- Numero di telefono: +41 61 325 51 11
- Email: Christina.stadler@upk.ch
Backup dei contatti dello studio
- Nome: Ana Cubillo, PhD
- Numero di telefono: +41 61 325 80 33
- Email: Ana.cubillo@upk.ch
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 10 anni a 18 anni (Bambino, Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Altro: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in performance accuracy in Geneva Emotion Recognition Test (GERT)
Lasso di tempo: Change in performance before and after the emotion recognition training, after 1 month (pre/post measure)
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Percentage of accuracy to stimuli showing facial emotions
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Change in performance before and after the emotion recognition training, after 1 month (pre/post measure)
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Change in performance response times in Geneva Emotion Recognition Test (GERT)
Lasso di tempo: Change in performance before and after the emotion recognition training, after 1 month (pre/post measure)
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Response times to stimuli showing facial emotions
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Change in performance before and after the emotion recognition training, after 1 month (pre/post measure)
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Change in performance reaction times in Social decision-making task
Lasso di tempo: Change in Performance before and after the emotion recognition training, after 1 month (pre/post measure)
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Reaction times for each of the facial emotions shown
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Change in Performance before and after the emotion recognition training, after 1 month (pre/post measure)
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Change in choices in Social decision-making task
Lasso di tempo: Change in choices before and after the emotion recognition training, after 1 month (pre/post measure)
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The proportion of choices that maximise their self-gain for each of the facial emotions shown
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Change in choices before and after the emotion recognition training, after 1 month (pre/post measure)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Anticipato)
15 aprile 2021
Completamento primario (Anticipato)
30 novembre 2021
Completamento dello studio (Anticipato)
30 novembre 2021
Date di iscrizione allo studio
Primo inviato
8 aprile 2021
Primo inviato che soddisfa i criteri di controllo qualità
13 aprile 2021
Primo Inserito (Effettivo)
14 aprile 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
14 aprile 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 aprile 2021
Ultimo verificato
1 aprile 2021
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- EmoRecTraining_EVA
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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