Back to resultsRecording Facial and Vocal Emotional Productions in Children With Autism as Part of the JEMImE Project
Primary Purpose
Autism, Pervasive Developmental Disorder
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Recordings of facial and vocal emotional productions
Sponsored by
About this trial
This is an interventional other trial for Autism focused on measuring autism, Pervasive Developmental Disorder
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of autism and Pervasive developmental disorder according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) criteria using scales (Autism Diagnostic Interview ADI and / or Autism Diagnostic Observation Schedule ADOS).
- Intelligence Quotient (IQ) = /> 70 (Wechsler Intelligence Scale for Children WISC IV)
- Subjects and holders of parental authority who have given their informed and written consent
- Subjects affiliated to social security system.
Exclusion Criteria:
- Subjects non affiliated to social security system.
Sites / Locations
- Fondation Lenval Hôpitaux Pédiatriques de Nice CHU-LENVAL
- Hôpital de La Salpétrière - APHP
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Recordings of facial and vocal emotional
Arm Description
Recordings of facial and vocal emotional productions during Children are performing three tasks
Outcomes
Primary Outcome Measures
Record facial and vocal emotional productions of children of an imitation situation
The outcome is the record with a 3D camera in test situations an imitation (facial and facial / vocal) situation of emotion expressed by an animated (on-screen) avatar with assessment of emotional production
Secondary Outcome Measures
Record facial and vocal emotional productions of children in a situation of mime on written request
The outcome is the record with a 3D camera in a situation of mime (facial and facial / vocal) on written request (on screen) with assessment of emotional production
Record facial and vocal emotional productions of children in a situation of mime on presentation of an image
The outcome is the record with a 3D camera in a situation of mime of an emotion on presentation of an image with assessment of emotional production
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03177590
Brief Title
Recording Facial and Vocal Emotional Productions in Children With Autism as Part of the JEMImE Project
Official Title
Recording Facial and Vocal Emotional Productions in Children With Autism as Part of the JEMImE Project
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 10, 2016 (Actual)
Primary Completion Date
July 10, 2017 (Actual)
Study Completion Date
July 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the JEMImE project is to create a serious game to help children with Autism and Pervasive Developmental Disorder (PDD) develop facial and vocal emotions in context.
The objective of this study is to record facial and vocal emotional productions in children with autism and PDD in order to create an algorithm for the recognition of facial emotional expressions implemented in the serious game JEMImE.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Pervasive Developmental Disorder
Keywords
autism, Pervasive Developmental Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Recordings of facial and vocal emotional
Arm Type
Experimental
Arm Description
Recordings of facial and vocal emotional productions during Children are performing three tasks
Intervention Type
Other
Intervention Name(s)
Recordings of facial and vocal emotional productions
Intervention Description
Children are asked to perform three tasks:
an emotional production on imitation (the child with autism or TED will imitate the emotion expressed by an animated avatar)
an emotional production by mime of the emotion on command (oral and written) without visualizing the model of imitation
Emotional production in context: the child with autism or EFD will describe images forming the story of Frog and as it is read, will produce the appropriate facial and vocal emotions in the context.
Primary Outcome Measure Information:
Title
Record facial and vocal emotional productions of children of an imitation situation
Description
The outcome is the record with a 3D camera in test situations an imitation (facial and facial / vocal) situation of emotion expressed by an animated (on-screen) avatar with assessment of emotional production
Time Frame
At baseline
Secondary Outcome Measure Information:
Title
Record facial and vocal emotional productions of children in a situation of mime on written request
Description
The outcome is the record with a 3D camera in a situation of mime (facial and facial / vocal) on written request (on screen) with assessment of emotional production
Time Frame
At baseline
Title
Record facial and vocal emotional productions of children in a situation of mime on presentation of an image
Description
The outcome is the record with a 3D camera in a situation of mime of an emotion on presentation of an image with assessment of emotional production
Time Frame
At baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of autism and Pervasive developmental disorder according to Diagnostic and Statistical Manual of Mental Disorders IV (DSM IV) criteria using scales (Autism Diagnostic Interview ADI and / or Autism Diagnostic Observation Schedule ADOS).
Intelligence Quotient (IQ) = /> 70 (Wechsler Intelligence Scale for Children WISC IV)
Subjects and holders of parental authority who have given their informed and written consent
Subjects affiliated to social security system.
Exclusion Criteria:
Subjects non affiliated to social security system.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie SERRET, MD
Organizational Affiliation
Fondation Lenval Hôpitaux Pédiatriques de Nice CHU-LENVAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation Lenval Hôpitaux Pédiatriques de Nice CHU-LENVAL
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Hôpital de La Salpétrière - APHP
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Recording Facial and Vocal Emotional Productions in Children With Autism as Part of the JEMImE Project
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