Pain and Emotional Expression in Children With Autism or Mental Retardation

Autism Clinical Trial

Official title:

Pain and Emotional Expression in Children With Autism or Mental Retardation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01043822
• Other study ID #: UF8481
• Status: Recruiting
• Phase: N/A
• First received: January 6, 2010
• Last updated: October 28, 2010
• Start date: December 2009
• Est. completion date: July 2011

Study information

• Verified date: October 2010
• Source: University Hospital, Montpellier
• Contact: Amaria BAGHDADLI, Pr
• Phone: 04 67 33 63 83
• Email: a-baghdadli[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months to 6 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Autism
• Autistic Disorder
• Intellectual Disability
• Mental Retardation

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France,