Autistic DisorderNCT02568631
Improving Social Cognition for Adults With ASD by the Serious Game JeStiMulE Versus Controls
A study testing serious game JeStiMulE in people with Autistic Disorder, run by Fondation Lenval at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- serious game JeStiMulE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesFrance
- Study dates
- 22 Sep 2015to 20 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- The subjects with unbalanced epilepsy
- The pregnant women
Trial locations and contacts
3 sites in 1 country.
France3 sites
Fondation Lenval
Nice, 06200
Hôpital Pasteur - CHU de Nice
Nice, 06300
Hôpital psychiatrique de Sainte marie
Nice, 06300
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Autistic Disorder
- Being tested
- serious game JeStiMulE, control video game
- Keywords
- Autistic Disorder
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serious game JeStiMulEOther
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.
control video gameOther
The patients will play 6 sessions of one hour with the control video game
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: serious game JeStiMulE |
| 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. Receives: Other: control video game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Comparaison at 4 weeks to baseline
Secondary outcomes (4)
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).
Measured: Comparaison at 4 weeks to baseline
Change of impact on quality of life
The impact on quality of life will be evaluated by Vineland test
Measured: Comparaison at 4 weeks to baseline
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
Measured: Comparaison at 4 weeks to baseline
Feedback from JeStiMulE players
the feedback from JeStiMulE players will be registered with a questionnary
Measured: Comparaison at 4 weeks to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study start22 Sep 2015
- Primary completion20 Sep 2016
- Study completion20 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie SERRET, MD, Principal investigator, Fondation Lenval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568631
- Sponsor's protocol ID
- 15-HPNCL-01
- Status last verified
- Jul 2018
- First submitted
- 29 Sep 2015
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02568631
- Acronym / sponsor ID
- 15-HPNCL-01
- Conditions
- Autistic Disorder
- Keywords
- Autistic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 22 Sep 2015 (actual)
- Primary completion
- 20 Sep 2016 (actual)
- Study completion
- 20 Sep 2017 (actual)
- First posted
- 6 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| serious game JeStiMulE | Experimental | Other: 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. |
| control video game | Placebo comparator | Other: 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- The subjects with unbalanced epilepsy
- The pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serious game JeStiMulEThe 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. | Other | serious game JeStiMulE |
| control video gameThe patients will play 6 sessions of one hour with the control video game | Other | control video game |
Primary outcome
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.
4 secondary outcomes
Change of Social cognition
Time frame: Comparaison at 4 weeks to baseline
Change of impact on quality of life
Time frame: Comparaison at 4 weeks to baseline
Impact on the verbal fluency of emotional words (number of words emitted perminute)
Time frame: Comparaison at 4 weeks to baseline
Feedback from JeStiMulE players
Time frame: Comparaison at 4 weeks to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie SERRET, MD principal investigator
Fondation Lenval
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serious game JeStiMulE in people with Autistic Disorder, run by Fondation Lenval at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Emotion recognition (time frame: Comparaison at 4 weeks to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018; AzTrials last refreshed its copy on 6 Nov 2026.