NCT01043822

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

October 29, 2010

Status Verified

October 1, 2010

Enrollment Period

1.5 years

First QC Date

January 6, 2010

Last Update Submit

October 28, 2010

Conditions

AutismMental Retardation

Keywords

Autismmental retardationpainemotionsensory profilechildren

Eligibility Criteria

Age18 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

46 children with autism spectrum disorders, 46 children with mental retardation, 46 children without developmental disorder

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University Hospital

Montpellier, 34000, France

RECRUITING

MeSH Terms

Conditions

Autistic DisorderIntellectual DisabilityPain

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amaria BAGHDADLI, Pr

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amaria BAGHDADLI, Pr

CONTACT

04 67 33 63 83a-baghdadli@chu-montpellier.fr

Amandine DUBOIS, PhD

CONTACT

04 67 33 96 63a-dubois@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 7, 2010

Study Start

December 1, 2009

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

October 29, 2010

Record last verified: 2010-10

Locations

FR(1)