AutismNCT01043822
Pain and Emotional Expression in Children With Autism or Mental Retardation
An observational study of Autism and Mental Retardation, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 months to 6 years
- Conditions the study is for
- Autism, Mental Retardation
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2009to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: 46 children with autism spectrum disorders, 46 children with mental retardation, 46 children without developmental disorder
Who may be able to join
- 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 .
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Montpellier University Hospital
Montpellier, 34000
Amaria BAGHDADLI, Pr, 04 67 33 63 83, a-baghdadli@chu-montpellier.fr
About this study
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).
Read the 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.
- Conditions
- Autism, Mental Retardation
- Keywords
- Autism, mental retardation, pain, emotion, sensory profile, children
- Medical subject headings
- Autistic Disorder, Intellectual Disability, Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionJun 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Investigators
- Amaria BAGHDADLI, Pr, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043822
- Sponsor's protocol ID
- UF8481
- Status last verified
- Oct 2010
- First submitted
- 6 Jan 2010
- Last updated
- 29 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Emotional Expression in Children With Autism or Mental Retardation
- ClinicalTrials.gov ID
- NCT01043822
- Acronym / sponsor ID
- UF8481
- Conditions
- Autism, Mental Retardation
- Keywords
- Autism, mental retardation, pain, emotion, sensory profile, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 7 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 46 children with autism spectrum disorders, 46 children with mental retardation, 46 children without developmental disorder
Key inclusion criteria (11 listed)
- 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
- Child aged 3 to 6 years old .
- Diagnosis of mental retardation established according a pluridisciplinary staff (ICD-10 criteria, Vineland scales, ADOS, etc.)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amaria BAGHDADLI, Pr principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Mental Retardation, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amaria BAGHDADLI, Pr (04 67 33 63 83, a-baghdadli@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2010.