Autism Spectrum DisordersematicNCT02791789
SEMATIC Pilot Study in Children With Autism Spectrum Disorder Using an Innovative Edutainment Software
A study testing Autism Spectrum Disorder in people with Autism Spectrum Disorder, run by Fondation Lenval at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Autism Spectrum Disorder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Feb 2015
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL
Nice, 06200
About this study
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)
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, SEMATIC, software
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autism Spectrum DisorderOther
Training to the serious game sematic, clinical exam, speech and language therapy and neuropsychological evaluations
| Study group | Role | What they receive |
|---|---|---|
| Autism Spectrum Disorder | Other | clinical exam, speech and language therapy and neuropsychological evaluations, Training to the SEMATIC serious game Receives: Other: Autism Spectrum Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure learning words and phrases while using SEMATIC in children with ASD and non-readers without functional language
minimum of 50 correct answers out of 100 in the learning score
Measured: Comparaison between before using SEMATIC serious game and after 11 weeks
Secondary outcomes (5)
Evaluate the impact of learning words and phrases on the acquisition of the lexicon (speech and language test ELO)
score to the ELO test
Measured: Comparaison between before using SEMATIC serious game and after 11 weeks
Evaluate the duration of the game necessary to learning
score of duration to the ergonomic Questionnaire
Measured: After using SEMATIC serious game after 11 weeks
Assess the number of sessions necessary to learning
score of number of session to the ergonomic Questionnaire
Measured: After using SEMATIC serious game after 11 weeks
Assess the technical performance and usability of the game platform
Ergonomic grid is created and given to parents and educators to evaluate the software, usability and technical performance of the game
Measured: After using SEMATIC serious game after 11 weeks
Evaluate the satisfaction of organizing the SEMATIC survey of parents and educators
score to the satisfaction questionnaire
Measured: After using SEMATIC serious game after 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startOct 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 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 - Hôpitaux Pédiatriques de Nice CHU-LENVAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791789
- Sponsor's protocol ID
- 14-HPNCL-10
- Acronym
- sematic
- Status last verified
- Jun 2016
- First submitted
- 1 Jun 2016
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02791789
- Acronym / sponsor ID
- sematic / 14-HPNCL-10
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, SEMATIC, software
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 7 Jun 2016 (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.
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.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autism Spectrum Disorder | Other | Other: Autism Spectrum Disorderclinical exam, speech and language therapy and neuropsychological evaluations, Training to the SEMATIC serious game |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Autism Spectrum DisorderTraining to the serious game sematic, clinical exam, speech and language therapy and neuropsychological evaluations | Other | Autism Spectrum Disorder |
Primary outcome
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
5 secondary outcomes
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
Evaluate the duration of the game necessary to learning
Time frame: After using SEMATIC serious game after 11 weeks
Assess the number of sessions necessary to learning
Time frame: After using SEMATIC serious game after 11 weeks
Assess the technical performance and usability of the game platform
Time frame: After using SEMATIC serious game after 11 weeks
Evaluate the satisfaction of organizing the SEMATIC survey of parents and educators
Time frame: After using SEMATIC serious game after 11 weeks
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 7 Jun 2016.
- Individual participant dataSharing planned: No
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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 - Hôpitaux Pédiatriques de Nice CHU-LENVAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autism Spectrum Disorder in people with Autism Spectrum Disorder, run by Fondation Lenval at 1 site 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 8 inclusion and 5 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 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
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). 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 7 Jun 2016.