NCT02791789

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
Last Updated

June 7, 2016

Status Verified

June 1, 2016

Enrollment Period

1.3 years

First QC Date

June 1, 2016

Last Update Submit

June 1, 2016

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum DisorderSEMATICsoftware

Outcome Measures

Primary Outcomes (1)

  • 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

    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)

    Comparaison between before using SEMATIC serious game and after 11 weeks

  • Evaluate the duration of the game necessary to learning

    After using SEMATIC serious game after 11 weeks

  • Assess the number of sessions necessary to learning

    After using SEMATIC serious game after 11 weeks

  • Assess the technical performance and usability of the game platform

    After using SEMATIC serious game after 11 weeks

  • Evaluate the satisfaction of organizing the SEMATIC survey of parents and educators

    After using SEMATIC serious game after 11 weeks

Study Arms (1)

Autism Spectrum Disorder

OTHER

clinical exam, speech and language therapy and neuropsychological evaluations, Training to the SEMATIC serious game

Other: Autism Spectrum Disorder

Interventions

Autism Spectrum DisorderOTHER

Training to the serious game sematic, clinical exam, speech and language therapy and neuropsychological evaluations

Autism Spectrum Disorder

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation LENVAL - Hôpitaux Pédiatriques de Nice CHU-LENVAL

Nice, 06200, France

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sylvie SERRET, MD

    Fondation Lenval - Hôpitaux Pédiatriques de Nice CHU-LENVAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2016

First Posted

June 7, 2016

Study Start

October 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 7, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)