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Improving Social Cognition for Adults With ASD by the Serious Game JeStiMulE Versus Controls

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ClinicalTrials.gov Identifier: NCT02568631
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Lenval

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Autistic Disorder Other: serious game JeStiMulE Other: control video game Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Improving Social Cognition for Adults With Autism Spectrum Disorder by the Serious Game JeStiMulE Versus Classic Video Game Stimulation Not Improving Social Cognition
Actual Study Start Date : September 22, 2015
Actual Primary Completion Date : September 20, 2016
Actual Study Completion Date : September 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: serious game JeStiMulE
  • 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.
Other: serious game JeStiMulE
The objective of JeStiMulE players will be ending the game after a learning period and two playing periods (with emotional words and idioms, which include three modules each). The session ends when the module is completed, which is approximately one hour per module, or 6 sessions of play.

Placebo Comparator: control video game
  • 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.
Other: control video game
The patients will play 6 sessions of one hour with the control video game




Primary Outcome Measures :
  1. Change of Emotion recognition [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change of Social cognition [ Time Frame: Comparaison at 4 weeks to baseline ]

    Comparaison at 4 weeks to baseline after playing 6 sessions of one hour of video game Jestimule or control.

    The rest of social cognition improvement by several tests (the theory of the mind with the score of the Tom-15, the intention with the score Sarfati cartoons, empathy with a self-administered questionnaire: EQ / AQ).


  2. Change of impact on quality of life [ Time Frame: Comparaison at 4 weeks to baseline ]
    The impact on quality of life will be evaluated by Vineland test

  3. Impact on the verbal fluency of emotional words (number of words emitted perminute) [ Time Frame: Comparaison at 4 weeks to baseline ]
    The verbal fluence is the number of words emitted per minute at a patient speaking describing a full of imagery scene

  4. Feedback from JeStiMulE players [ Time Frame: Comparaison at 4 weeks to baseline ]
    the feedback from JeStiMulE players will be registered with a questionnary



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • The subjects with unbalanced epilepsy
  • The pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568631


Locations
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France
Fondation Lenval
Nice, France, 06200
Hôpital Pasteur - CHU de Nice
Nice, France, 06300
Hôpital psychiatrique de Sainte marie
Nice, France, 06300
Sponsors and Collaborators
Fondation Lenval
Investigators
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Principal Investigator: Sylvie SERRET, MD Fondation Lenval
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Responsible Party: Fondation Lenval
ClinicalTrials.gov Identifier: NCT02568631    
Other Study ID Numbers: 15-HPNCL-01
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Keywords provided by Fondation Lenval:
Autistic Disorder
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders