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

NCT02568631 | Completed

• 1 other identifier: 15-HPNCL-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Autistic Disorder

Keywords

Autistic Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Comparaison at 4 weeks to baseline

Secondary Outcomes (4)

• Change of Social cognition

  Comparaison at 4 weeks to baseline

• Change of impact on quality of life

  Comparaison at 4 weeks to baseline

• Impact on the verbal fluency of emotional words (number of words emitted perminute)

  Comparaison at 4 weeks to baseline

• Feedback from JeStiMulE players

  Comparaison at 4 weeks to baseline

Study Arms (2)

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.

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.

Other: control video game

Interventions

serious game JeStiMulE OTHER

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.

serious game JeStiMulE

control video game OTHER

The patients will play 6 sessions of one hour with the control video game

control video game

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• The subjects with unbalanced epilepsy
• The pregnant women

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (3)

Fondation Lenval

Nice, 06200, France

Location

Hôpital Pasteur - CHU de Nice

Nice, 06300, France

Location

Hôpital psychiatrique de Sainte marie

Nice, 06300, France

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Sylvie SERRET, MD

  Fondation Lenval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 6, 2015
• Study Start: September 22, 2015
• Primary Completion: September 20, 2016
• Study Completion: September 20, 2017
• Last Updated: July 31, 2018

Record last verified: 2018-07

Locations

FR (3)