AutismNCT03177590
Recording Facial and Vocal Emotional Productions in Children With Autism as Part of the JEMImE Project
A study testing Recordings of facial and vocal emotional productions in people with Autism and Pervasive Developmental Disorder, run by Fondation Lenval at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Autism, Pervasive Developmental Disorder
- What is being tested?
- Recordings of facial and vocal emotional productions
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesFrance
- Study dates
- 10 May 2016to 10 Jul 2017
- 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
- 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.
Who cannot join
- Subjects non affiliated to social security system.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Fondation Lenval Hôpitaux Pédiatriques de Nice CHU-LENVAL
Nice, 06200
Hôpital de La Salpétrière - APHP
Paris, 75013
About this study
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.
- Conditions
- Autism, Pervasive Developmental Disorder
- Being tested
- Recordings of facial and vocal emotional productions
- Keywords
- autism, Pervasive Developmental Disorder
- Medical subject headings
- Autistic Disorder, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recordings of facial and vocal emotional productionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Recordings of facial and vocal emotional | Experimental | Recordings of facial and vocal emotional productions during Children are performing three tasks Receives: Other: Recordings of facial and vocal emotional productions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline
Secondary outcomes (2)
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
Measured: At baseline
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
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start10 May 2016
- Primary completion10 Jul 2017
- Study completion10 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT03177590
- Sponsor's protocol ID
- 15-HPNCL-02
- Status last verified
- Jul 2018
- First submitted
- 22 Feb 2017
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recording Facial and Vocal Emotional Productions in Children With Autism as Part of the JEMImE Project
- ClinicalTrials.gov ID
- NCT03177590
- Acronym / sponsor ID
- 15-HPNCL-02
- Conditions
- Autism, Pervasive Developmental Disorder
- Keywords
- autism, Pervasive Developmental Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 10 May 2016 (actual)
- Primary completion
- 10 Jul 2017 (actual)
- Study completion
- 10 Jul 2017 (actual)
- First posted
- 6 Jun 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recordings of facial and vocal emotional | Experimental | Other: Recordings of facial and vocal emotional productionsRecordings of facial and vocal emotional productions during Children are performing three tasks |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects non affiliated to social security system.
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 |
|---|---|---|
| Recordings of facial and vocal emotional productionsChildren are asked to perform three tasks: 1. an emotional production on imitation (the child with autism or TED will imitate the emotion expressed by an animated avatar) 2. an emotional production by mime of the emotion on command (oral and written) without visualizing the model of imitation 3. 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. | Other | Recordings of facial and vocal emotional |
Primary outcome
Record facial and vocal emotional productions of children of an imitation situation
Time frame: At baseline
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
2 secondary outcomes
Record facial and vocal emotional productions of children in a situation of mime on written request
Time frame: At baseline
Record facial and vocal emotional productions of children in a situation of mime on presentation of an image
Time frame: At baseline
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 31 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Autism
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recordings of facial and vocal emotional productions in people with Autism and Pervasive Developmental Disorder, run by Fondation Lenval at 2 sites 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 4 inclusion and 1 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 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Record facial and vocal emotional productions of children of an imitation situation (time frame: At baseline). 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 31 Jul 2018.