Pain and Emotional Expression in Children With Autism or Mental Retardation

The recruitment status of this study is unknown because the information has not been verified recently.
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
  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

Ages Eligible for Study:   18 Months to 6 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Pr Baghdadli, University Hospital Montpellier
ClinicalTrials.gov Identifier: NCT01043822     History of Changes
Other Study ID Numbers: UF8481
Study First Received: January 6, 2010
Last Updated: October 28, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Mental Disorders Diagnosed in Childhood
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014