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

Primary Purpose

Autistic Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
serious game JeStiMulE
control video game
Sponsored by
Fondation Lenval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autistic Disorder focused on measuring Autistic Disorder

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondation Lenval
  • Hôpital Pasteur - CHU de Nice
  • Hôpital psychiatrique de Sainte marie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

serious game JeStiMulE

control video game

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of Emotion recognition
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

Change of Social cognition
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).
Change of impact on quality of life
The impact on quality of life will be evaluated by Vineland test
Impact on the verbal fluency of emotional words (number of words emitted perminute)
The verbal fluence is the number of words emitted per minute at a patient speaking describing a full of imagery scene
Feedback from JeStiMulE players
the feedback from JeStiMulE players will be registered with a questionnary

Full Information

First Posted
September 29, 2015
Last Updated
July 27, 2018
Sponsor
Fondation Lenval
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1. Study Identification

Unique Protocol Identification Number
NCT02568631
Brief Title
Improving Social Cognition for Adults With ASD by the Serious Game JeStiMulE Versus Controls
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 22, 2015 (Actual)
Primary Completion Date
September 20, 2016 (Actual)
Study Completion Date
September 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. 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 group of fifteen adults with a diagnosis of autism objectified. This group will use JeStiMulE and will be compared to a control group of fifteen 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, 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. 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 of the Sarfati BD, empathy with a self-administered questionnaire: EQ / AQ). All these elements will be tested before and after the playing session to assess improvement of social cognition. - 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
Keywords
Autistic Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
serious game JeStiMulE
Arm Type
Experimental
Arm Description
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.
Arm Title
control video game
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
serious game JeStiMulE
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
control video game
Intervention Description
The patients will play 6 sessions of one hour with the control video game
Primary Outcome Measure Information:
Title
Change of Emotion recognition
Description
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.
Time Frame
Comparaison at 4 weeks to baseline
Secondary Outcome Measure Information:
Title
Change of Social cognition
Description
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).
Time Frame
Comparaison at 4 weeks to baseline
Title
Change of impact on quality of life
Description
The impact on quality of life will be evaluated by Vineland test
Time Frame
Comparaison at 4 weeks to baseline
Title
Impact on the verbal fluency of emotional words (number of words emitted perminute)
Description
The verbal fluence is the number of words emitted per minute at a patient speaking describing a full of imagery scene
Time Frame
Comparaison at 4 weeks to baseline
Title
Feedback from JeStiMulE players
Description
the feedback from JeStiMulE players will be registered with a questionnary
Time Frame
Comparaison at 4 weeks to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie SERRET, MD
Organizational Affiliation
Fondation Lenval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation Lenval
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Hôpital Pasteur - CHU de Nice
City
Nice
ZIP/Postal Code
06300
Country
France
Facility Name
Hôpital psychiatrique de Sainte marie
City
Nice
ZIP/Postal Code
06300
Country
France

12. IPD Sharing Statement

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

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