Asperger SyndromeNCT00505830
Evaluation of the French Version of Screening Questionnaires for Autism and Asperger Syndrome: AQ, EQ and SQ
An observational study of Asperger Syndrome and Autism, run by Groupe Francais d'Epidemiologie Psychiatrique at 1 site in France.
Trial summary
Autism is considered as an invading disorder of the development. Asperger Syndrome (AS) is a particular form of autism and is difficult to diagnose. The Autism Spectrum Quotient (AQ) has been developed in order to measure the degree of autistic traits in autistic adolescent with normal intelligence (Baron-Cohen et al. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Asperger Syndrome, Autism
- What is being tested?
- questionnaires
- Type of treatment
- Injection or infusion
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2007to Jul 2009
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Group 1 (AS/HFA) and 2 (AS/classic autism) :
- Boys and girls aged 12 to 18
- Patients with autism or Asperger syndrome according to the diagnostic criteria (ICD 10)
- Patients receiving education in an ordinary school
- IQ>70
- Group 3 (adolescents with psychiatric disorders):
Show all 12Show fewer
- Boys and girls aged 12 to 18
- Patients hospitalized on a psychiatric ward or at a psychiatrics patient visit or psychiatric consultation wit hout autistic syndrome
- Patients receiving education in an ordinary school when not in hospital
- Group 4 (adolescent without psychiatric syndrome):
- Boys and girls aged 12 to 18
- Patients receiving education in an ordinary school
Who cannot join
- For all groups :
- Problem with language or comprehension
- Participants who have not given their consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Saint Jean de Dieu
Lyon
Sabine Manificat, MDH, +33 4 37 90 12 96, smanificat@arhm-sjd.fr
Berhouz Kassai, MD, PhD, bk@upcl.univ-lyon1.fr
About this study
Official title: Evaluation of the French Version of Screening Questionnaires for Autism and Asperger Syndrome : Autism Spectrum Quotient (AQ) Empathy Quotient (EQ) and Systemizing Quotient (SQ)
Autism is considered as an invading disorder of the development. Asperger Syndrome (AS) is a particular form of autism and is difficult to diagnose. The Autism Spectrum Quotient (AQ) has been developed in order to measure the degree of autistic traits in autistic adolescent with normal intelligence (Baron-Cohen et al. 2001, 2006). AQ comprises 50 questions, with 5 groups of 10 questions assessing imagination, social skills, attention switching, attention to detail and communication skills. Each of these items scores 1 point if the respondent records abnormal or autistic like behaviour. The minimum score on the AQ is 0 and the maximum 50.
The principal objective of this study is to evaluate the accuracy of the French version of Autism Spectrum Quotient questionnaire.
Read more
Secondary objectives are to:
Evaluate if EQ and SQ can distinguish adolescents without psychiatric syndromes from those with classical autism or AS.
Evaluate if AQ, EQ and SQ can distinguish adolescents with psychiatric disorders from autistic adolescents.
Define the threshold of positivity for the 3 questionnaires.
Read the detailed description
4 groups of participants will be screened with the questionnaires: Group 1: 50 adolescents with AS or high functioning autism (HFS) diagnosed by psychiatrists using established criteria and with an IQ >85.
Group 2: 50 adolescents with AS or classical autism diagnosed by psychiatrists using established criteria 70<IQ<84.
Group 3: 50 adolescents with psychiatric disorders. Group 4: Sample of 50 healthy adolescents selected randomly from 200. The questionnaires are given to the parents of adolescents during the first meeting. Parents are invited to send them back to the clinical investigation centre of Lyon (France).
Multicentre study: 8 clinical centres and 18 paediatricians
- Conditions
- Asperger Syndrome, Autism
- Being tested
- questionnaires
- Keywords
- Asperger Syndrom, Autism Quotient, French version, screening, diagnostic test, accuracy
- Medical subject headings
- Asperger Syndrome, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
Primary outcome:
Autism Spectrum Quotient (AQ)
Secondary outcome measure:
Empathy quotient (EQ) Systemizing quotient (SQ) WISC III or WISC IV ADOS score ADI score
| Study group | Role | What they receive |
|---|---|---|
| 1 | 50 adolescents with AS or high functioning autism (HFS) diagnosed by psychiatrists using established criteria and with an IQ >85. Receives: Other: questionnaires | |
| 2 | 50 adolescents with AS or classical autism diagnosed by psychiatrists using established criteria 70<IQ<84. Receives: Other: questionnaires | |
| 3 | 50 adolescents with psychiatric disorders but no autism syndrom. Receives: Other: questionnaires | |
| 4 | Sample of 50 healthy adolescents selected randomly from 200. Receives: Other: questionnaires |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startJul 2007
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asperger SyndromeStudies of the same condition, open and under way.
- 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Francais d'Epidemiologie Psychiatrique
- Sponsor type
- University, hospital or other
- Collaborators
- Joint Clinical Research Center
- Investigators
- Sabine Manificat, MDH, Principal investigator, Centre Hospitalier Saint Jean de Dieu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505830
- Sponsor's protocol ID
- Autisme AQ
- Status last verified
- Jul 2007
- First submitted
- 23 Jul 2007
- Last updated
- 25 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the French Version of Screening Questionnaires for Autism and Asperger Syndrome : Autism Spectrum Quotient (AQ) Empathy Quotient (EQ) and Systemizing Quotient (SQ)
- ClinicalTrials.gov ID
- NCT00505830
- Acronym / sponsor ID
- Autisme AQ
- Conditions
- Asperger Syndrome, Autism
- Keywords
- Asperger Syndrom, Autism Quotient, French version, screening, diagnostic test, accuracy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Groupe Francais d'Epidemiologie PsychiatriqueUniversity, hospital or other
- Collaborators
- Joint Clinical Research Center
- Study start
- Jul 2007
- Study completion
- Jul 2009 (estimated)
- First posted
- 25 Jul 2007 (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.
Autism is considered as an invading disorder of the development. Asperger Syndrome (AS) is a particular form of autism and is difficult to diagnose. The Autism Spectrum Quotient (AQ) has been developed in order to measure the degree of autistic traits in autistic adolescent with normal intelligence (Baron-Cohen et al. 2001, 2006). AQ comprises 50 questions, with 5 groups of 10 questions assessing imagination, social skills, attention switching, attention to detail and communication skills. Each of these items scores 1 point if the respondent records abnormal or autistic like behaviour. The minimum score on the AQ is 0 and the maximum 50.
The principal objective of this study is to evaluate the accuracy of the French version of Autism Spectrum Quotient questionnaire.
Secondary objectives are to:
Evaluate if EQ and SQ can distinguish adolescents without psychiatric syndromes from those with classical autism or AS.
Evaluate if AQ, EQ and SQ can distinguish adolescents with psychiatric disorders from autistic adolescents.
Define the threshold of positivity for the 3 questionnaires.
Detailed description
4 groups of participants will be screened with the questionnaires: Group 1: 50 adolescents with AS or high functioning autism (HFS) diagnosed by psychiatrists using established criteria and with an IQ >85.
Group 2: 50 adolescents with AS or classical autism diagnosed by psychiatrists using established criteria 70<IQ<84.
Group 3: 50 adolescents with psychiatric disorders. Group 4: Sample of 50 healthy adolescents selected randomly from 200. The questionnaires are given to the parents of adolescents during the first meeting. Parents are invited to send them back to the clinical investigation centre of Lyon (France).
Multicentre study: 8 clinical centres and 18 paediatricians
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: questionnaires50 adolescents with AS or high functioning autism (HFS) diagnosed by psychiatrists using established criteria and with an IQ >85. |
| 2 | – | Other: questionnaires50 adolescents with AS or classical autism diagnosed by psychiatrists using established criteria 70<IQ<84. |
| 3 | – | Other: questionnaires50 adolescents with psychiatric disorders but no autism syndrom. |
| 4 | – | Other: questionnairesSample of 50 healthy adolescents selected randomly from 200. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Boys and girls aged 12 to 18
- Patients with autism or Asperger syndrome according to the diagnostic criteria (ICD 10)
- Patients receiving education in an ordinary school
- IQ>70
- Boys and girls aged 12 to 18
Key exclusion criteria (3 listed)
- Problem with language or comprehension
- Participants who have not given their consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesPrimary outcome: Autism Spectrum Quotient (AQ) Secondary outcome measure: Empathy quotient (EQ) Systemizing quotient (SQ) WISC III or WISC IV ADOS score ADI score | Other | 1, 2, 3, 4 |
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 25 Jul 2007.
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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.
Sabine Manificat, MDH principal investigator
Centre Hospitalier Saint Jean de Dieu
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 Asperger Syndrome and Autism, run by Groupe Francais d'Epidemiologie Psychiatrique 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 12 inclusion and 3 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 25 Jul 2007. 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 Jean-Pierre Vignat, MDH (+33 4 37 90 11 75, jpvignat@ch-st-jean-de-dieu-lyon.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 25 Jul 2007.