Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Pain and Emotional Expression in Children With Autism or Mental Retardation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01043822
First received: January 6, 2010
Last updated: October 28, 2010
Last verified: October 2010

January 6, 2010
October 28, 2010
December 2009
June 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01043822 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pain and Emotional Expression in Children With Autism or Mental Retardation
Pain and Emotional Expression in Children With Autism or Mental Retardation
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).
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.
Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample
46 children with autism spectrum disorders, 46 children with mental retardation, 46 children without developmental disorder
  • Autism
  • Mental Retardation
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
138
July 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Months to 6 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01043822
UF8481
Yes
Not Provided
Not Provided
Pr Baghdadli, University Hospital Montpellier
University Hospital, Montpellier
Not Provided
Principal Investigator: Amaria BAGHDADLI, Pr Montpellier University Hospital
University Hospital, Montpellier
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP