- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01043822
Pain and Emotional Expression in Children With Autism or Mental Retardation
October 28, 2010 updated by: University Hospital, Montpellier
The purpose of this study is to describe facial, behavioral and physiologic (heart rate) reactivity of children with autism aged 3 to 6 years old, during a painful stimulation (venepuncture).
Children will be videotaped before, during and after a venepuncture.
Each recording will be rated with the FACS (Facial Action Coding System) and the NCCPC (Non Communicating Children's Pain Checklist).
Study Overview
Status
Unknown
Conditions
Detailed Description
Children with autism will be matched with children with mental retardation and children without developmental disorder.
Matching will be established according the developmental age of children with autism.
Study Type
Observational
Enrollment (Anticipated)
138
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amaria BAGHDADLI, Pr
- Phone Number: 04 67 33 63 83
- Email: a-baghdadli@chu-montpellier.fr
Study Contact Backup
- Name: Amandine DUBOIS, PhD
- Phone Number: 04 67 33 96 63
- Email: a-dubois@chu-montpellier.fr
Study Locations
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-
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Montpellier, France, 34000
- Recruiting
- Montpellier University Hospital
-
Contact:
- Amaria BAGHDADLI, Pr
- Phone Number: 04 67 33 63 83
- Email: a-baghdadli@chu-montpellier.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
46 children with autism spectrum disorders, 46 children with mental retardation, 46 children without developmental disorder
Description
Inclusion Criteria:
Group Autism:
- Child aged 3 to 6 years old
- Diagnosis of autistic disorder established according a pluridisciplinary staff (ICD-10 criteria, Vineland scales, ADOS, etc.)
- Admitted to children's neuropediatrics or genetics department for a venepuncture
Control group mental retardation:
- Child aged 3 to 6 years old .
- Diagnosis of mental retardation established according a pluridisciplinary staff (ICD-10 criteria, Vineland scales, ADOS, etc.)
- Admitted to neuropediatric or genetic department for a venepuncture
Control group without developmental disorder :
- Child aged 18 months to 5 years old.
- Admitted to pediatrics department for a venepuncture
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amaria BAGHDADLI, Pr, Montpellier University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Anticipated)
June 1, 2011
Study Completion (Anticipated)
July 1, 2011
Study Registration Dates
First Submitted
January 6, 2010
First Submitted That Met QC Criteria
January 6, 2010
First Posted (Estimate)
January 7, 2010
Study Record Updates
Last Update Posted (Estimate)
October 29, 2010
Last Update Submitted That Met QC Criteria
October 28, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UF8481
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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