跳至主要内容
临床试验/NCT02568631
NCT02568631已完成不适用

Improving Social Cognition for Adults With Autism Spectrum Disorder by the Serious Game JeStiMulE Versus Classic Video Game Stimulation Not Improving Social Cognition

Fondation Lenval6 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年9月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
6
主要终点
Change of Emotion recognition

研究概览

简要总结

The serious game "JeStiMulE" (Educational Game for Multisensory Stimulation of Children with developmental disorders), developed by the Autism Resources Center of Nice, was created to teach social cognition including emotion recognition in context, for children and adolescents with autism. In a previous study, JeStiMulE has demonstrated efficacy in a population of young people aged 6-17 years old with high and low levels of autism.

According to the recommendations of the 2011 HAS, disorders of social interactions are the most persistent troubles of the autistic triad in life.

It seems essential to us to be able to offer young adults with autism, rehabilitation methods adapted to their trouble, and to observe whether JeStiMulE could be one of them.

This study researches the effectiveness of the serious game JeStiMulE in the improvement social cognition for adults with autism versus controls.

The main goal is:

  • Comparing the improvement in social cognition among adults with autism using the serious game JeStiMulE or not.

Two groups will be formed: a first one of fifteen adults with a diagnosis of autism objectified, this group will use JeStiMulE and will be compared to a control group of adults with autism, using another video game, not aimed to improve social cognition.

The objective of JeStiMulE players will be ending the game after a learning period and two playing periods (with emotional words and idioms, including three modules each). The groups will be matched with their nonverbal IQ through Raven matrices and visual memory tasks (WAIS).

The control group will also be stimulated through a video game, not specialized in improving social cognition.

The primary outcome will be assessed by the emotion recognition at the FEEST of Ekman test: by the number of emotions recognized on faces, compared to the number of emotion presented through this test.

The secondary outcomes will be:

  • The rest of social cognition improvement by several tests (the theory of mind with the score of the Tom-15, the intention with the score Sarfati cartoons, empathy with a self-administered questionnaire: EQ / AQ).
  • The impact on the quality of life, verbal fluency of emotional words, and the feedback from JeStiMulE players will also be seen as a secondary outcome.

详细描述

A lot of studies found a deficit in social cognition for individuals with autism, especially in emotions recognition, more precisely the negative emotions. These studies refer to the population of adults with high-functioning autism, but few reports results for low levels.

The serious game "JeStiMulE" (Educational Game for Multisensory Stimulation of Children with developmental disorders), developed by the Autism Resources Center of Nice, was created to teach social cognition including emotion recognition in context, for children and adolescents with autism, by developing a fun game environment; so that children and adolescents with autism spectrum disorder can experience virtual reality in reciprocal social interactions (emotions recognition, emotional gestures, communication, ...). In a previous study, JeStiMulE has demonstrated its efficacy in a population of young people aged 6-17 years old with high and low levels of autism.

According to the recommendations of the 2011 HAS, disorders of social interactions are the most persistent troubles of the autistic triad in life. But, early stimulation offered by educational provision and care has a positive influence on the development of these disorders.

It seems essential to us to be able to offer young adults with autism, rehabilitation methods adapted to their trouble, and to observe whether JeStiMulE could be one of them.

This study researches the effectiveness of the serious game JeStiMulE in the improvement of social cognition for adults with autism versus controls.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects from 18 to 40 years old.
  • Diagnosis of autism according to the diagnostic criteria of the DSM 5
  • Cognitive level estimated by the matrices of Raven > 6 years amount age
  • Compatible verbal level with the realization of the neurocognitive tests estimated by the verbal indication of understanding of the WAIS
  • Legal Subjects or guardian having given their informed consent and written;
  • Subjects affiliated to the Social Security.

排除标准

  • The subjects with unbalanced epilepsy
  • The pregnant women

研究组 & 干预措施

serious game JeStiMulE

Experimental
  • Evaluation of the social cognition for adults with autism.
  • The objective of the players of JeStiMulE (Educational Game for Multisensory Stimulation of Children with developmental disorders) will be to end the game after a period of learning and two periods of game (with emotional words and with idiomatic expressions understanding each three modules). The session ends when the module is carried out, what corresponds approximately at 1 am by module, that is 6 sessions of game.
  • Evaluation of the social cognition for adults with autism.

干预措施: serious game JeStiMulE (Other)

control video game

Placebo Comparator
  • Evaluation of the social cognition for adults with autism.
  • The objective of the players of the control video game will be to play 6 sessions of one hour.
  • Evaluation of the social cognition for adults with autism.

干预措施: control video game (Other)

结局指标

主要结局

Change of Emotion recognition

时间窗: Comparaison at 4 weeks to baseline

assessed by the emotion recognition at the FEEST of Ekman test: by the number of emotions recognized on faces, compared to the number of emotion presented through this test.

次要结局

  • Impact on the verbal fluency of emotional words (number of words emitted perminute)(Comparaison at 4 weeks to baseline)
  • Change of Social cognition(Comparaison at 4 weeks to baseline)
  • Change of impact on quality of life(Comparaison at 4 weeks to baseline)
  • Feedback from JeStiMulE players(Comparaison at 4 weeks to baseline)

研究者

发起方
Fondation Lenval
申办方类型
Other
责任方
Sponsor

研究点 (6)

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