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SEMATIC Pilot Study in Children With Autism Spectrum Disorder Using an Innovative Edutainment Software (sematic)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02791789
First Posted: June 7, 2016
Last Update Posted: June 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fondation Lenval
  Purpose

Use of the software could allow learning of reading code in subjects with ASD through the design of serious games for educational and therapeutic purposes.

This SEMATIC software could improve communication and could be integrated into medical management (speech therapy and neuropsychological).

The benefit of an action research will enable training professionals to autism, cognitive characteristics of autism and the use of IT support for this population.


Condition Intervention
Autism Spectrum Disorder Other: Autism Spectrum Disorder

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Multicenter Pilot Study: Measuring the Evolution of Learning Words and Phrases in Children With Autism Spectrum Disorder Using an Innovative Edutainment Software (SEMATIC)

Resource links provided by NLM:


Further study details as provided by Fondation Lenval:

Primary Outcome Measures:
  • measure learning words and phrases while using SEMATIC in children with ASD and non-readers without functional language [ Time Frame: Comparaison between before using SEMATIC serious game and after 11 weeks ]
    minimum of 50 correct answers out of 100 in the learning score


Secondary Outcome Measures:
  • Evaluate the impact of learning words and phrases on the acquisition of the lexicon (speech and language test ELO) [ Time Frame: Comparaison between before using SEMATIC serious game and after 11 weeks ]
    score to the ELO test

  • Evaluate the duration of the game necessary to learning [ Time Frame: After using SEMATIC serious game after 11 weeks ]
    score of duration to the ergonomic Questionnaire

  • Assess the number of sessions necessary to learning [ Time Frame: After using SEMATIC serious game after 11 weeks ]
    score of number of session to the ergonomic Questionnaire

  • Assess the technical performance and usability of the game platform [ Time Frame: After using SEMATIC serious game after 11 weeks ]
    Ergonomic grid is created and given to parents and educators to evaluate the software, usability and technical performance of the game

  • Evaluate the satisfaction of organizing the SEMATIC survey of parents and educators [ Time Frame: After using SEMATIC serious game after 11 weeks ]
    score to the satisfaction questionnaire


Enrollment: 17
Study Start Date: October 2013
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Autism Spectrum Disorder
clinical exam, speech and language therapy and neuropsychological evaluations, Training to the SEMATIC serious game
Other: Autism Spectrum Disorder
Training to the serious game sematic, clinical exam, speech and language therapy and neuropsychological evaluations

Detailed Description:

SEMATIC is an innovative collaborative project which aims to develop an edutainment software for learning words and phrases from logic games. This software is designed for children with autism spectrum disorder (ASD) who do not have the normal prerequisites for learning to read (that is to say: the understanding of words, verbal expression and phonological awareness). In addition, this project is based on hyper competence in the visual field of children with ASD by providing a playful computer support and access to specific visual interests of these children. IT support is a useful tool because it is stable and predictable for focusing the child's attention with ASD. To date, none of learning reading software does exist for children with ASD. This project is based on innovative theoretical and methodological assumptions. These assumptions are derived directly from observation, clinical knowledge of the autistic disorder, testimonies of families and individuals with Asperger Syndrome or Autism High Level and the contributions of the scientific literature in the field of autism.

This software was designed to improve the secondary verbal children with ASD as well as medical care (speech therapist and neuropsychological). The SEMATIC software could be integrated into traditional care for children with ASD. This project is part of an approach of 'action research'. Indeed, this research aims to boost health care teams by training cognitive characteristics of children with ASD and the use of computer support (SEMATIC). Fifteen children with ASD will be recruited in various institutions in the PACA region (departments 06 and 83) to participate in this study. All participants will use the software in the institution where they are usually supported but also at home.

Thus the interest of SEMATIC project is to develop learning words and phrases on computer using logic games to go towards learning the reading code for children with ASD do not have the usual prerequisites. This is a pilot study. There is currently no equivalent method for measuring these changes.

The assessment of learning will be carried out at different times of the protocol. Tests created specifically for the needs of the study will be used. Some tests commonly used in speech therapy and neuropsychological assessments (Standard tools validated on the recommendation of the HAS, 2005) will also be used to include topics and define the characteristics of the population of this study.

  Eligibility

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Review satisfactory medical eligibility criteria
  • Diagnosis disorder autism spectrum (ASD) according to the diagnostic criteria of ICD-10 and positive scores to the FA and / or ADOS
  • rated severity of autistic symptoms (overall score in the CARS-T scale greater than 30) Non-topics with a functional language (item 11 score ≥ 3 points of the CARS-T)
  • a equivalence of higher developmental age or equal to 5 years in analogical reasoning
  • n'ayant not develop reading skills by testing the Alouette
  • having an interest in visual media (television, computer, touch pad, ...)
  • Representatives of parental authority who gave informed written consent
  • Subject affiliated to social security

Exclusion Criteria:

  • Somatic problems secondarily generate behavioral problems while disrupting their participation in the study
  • The Patient having developed reading skills or benefiting from learning to read
  • The Patient with no ASD diagnosis according to ICD-10 criteria
  • The Patient not affiliated to the social security
  • Participant to another research protocol
  Contacts and Locations
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): NCT02791789


Locations
France
Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL
Nice, France, 06200
Sponsors and Collaborators
Fondation Lenval
Investigators
Principal Investigator: Sylvie SERRET, MD Fondation Lenval - Hôpitaux Pédiatriques de Nice CHU-LENVAL
  More Information

Responsible Party: Fondation Lenval
ClinicalTrials.gov Identifier: NCT02791789     History of Changes
Other Study ID Numbers: 14-HPNCL-10
First Submitted: June 1, 2016
First Posted: June 7, 2016
Last Update Posted: June 7, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Fondation Lenval:
Autism Spectrum Disorder
SEMATIC
software

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders