- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04845243
Effectiveness of a Short Computer-based Emotion Recognition Training in Different Patient Groups
13 de abril de 2021 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Antecipado)
80
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Christina Stadler, Professor
- Número de telefone: +41 61 325 51 11
- E-mail: Christina.stadler@upk.ch
Estude backup de contato
- Nome: Ana Cubillo, PhD
- Número de telefone: +41 61 325 80 33
- E-mail: Ana.cubillo@upk.ch
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
10 anos a 18 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in performance accuracy in Geneva Emotion Recognition Test (GERT)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
15 de abril de 2021
Conclusão Primária (Antecipado)
30 de novembro de 2021
Conclusão do estudo (Antecipado)
30 de novembro de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
8 de abril de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de abril de 2021
Primeira postagem (Real)
14 de abril de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de abril de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de abril de 2021
Última verificação
1 de abril de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EmoRecTraining_EVA
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .