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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:
ClinicalTrials.gov Identifier:
NCT01043822
First Posted: January 7, 2010
Last Update Posted: October 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Montpellier
  Purpose
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).

Condition
Autism Mental Retardation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Pain and Emotional Expression in Children With Autism or Mental Retardation

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Estimated Enrollment: 138
Study Start Date: December 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
46 children with autism spectrum disorders, 46 children with mental retardation, 46 children without developmental disorder
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043822


Contacts
Contact: Amaria BAGHDADLI, Pr 04 67 33 63 83 a-baghdadli@chu-montpellier.fr
Contact: Amandine DUBOIS, PhD 04 67 33 96 63 a-dubois@chu-montpellier.fr

Locations
France
Montpellier University Hospital Recruiting
Montpellier, France, 34000
Contact: Amaria BAGHDADLI, Pr    04 67 33 63 83    a-baghdadli@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Amaria BAGHDADLI, Pr Montpellier University Hospital
  More Information

Responsible Party: Pr Baghdadli, University Hospital Montpellier
ClinicalTrials.gov Identifier: NCT01043822     History of Changes
Other Study ID Numbers: UF8481
First Submitted: January 6, 2010
First Posted: January 7, 2010
Last Update Posted: October 29, 2010
Last Verified: October 2010

Keywords provided by University Hospital, Montpellier:
Autism
mental retardation
pain
emotion
sensory profile
children

Additional relevant MeSH terms:
Autistic Disorder
Intellectual Disability
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms


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