NCT03177590

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2017

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

February 22, 2017

Last Update Submit

July 27, 2018

Conditions

Keywords

autismPervasive Developmental Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

    At baseline

Secondary Outcomes (2)

  • Record facial and vocal emotional productions of children in a situation of mime on written request

    At baseline

  • Record facial and vocal emotional productions of children in a situation of mime on presentation of an image

    At baseline

Study Arms (1)

Recordings of facial and vocal emotional

EXPERIMENTAL

Recordings of facial and vocal emotional productions during Children are performing three tasks

Other: Recordings of facial and vocal emotional productions

Interventions

Children 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.

Recordings of facial and vocal emotional

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects non affiliated to social security system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fondation Lenval Hôpitaux Pédiatriques de Nice CHU-LENVAL

Nice, 06200, France

Location

Hôpital de La Salpétrière - APHP

Paris, 75013, France

Location

MeSH Terms

Conditions

Autistic DisorderChild Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderNeurodevelopmental 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
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2017

First Posted

June 6, 2017

Study Start

May 10, 2016

Primary Completion

July 10, 2017

Study Completion

July 10, 2017

Last Updated

July 31, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations