Autism Spectrum DisorderRAADS-RNCT02826148
Validation of the French Adaptation of the RAADS-R Scale : Scale of Asperger Syndrome Diagnosis
A study testing RAADS-R scale in people with Autism Spectrum Disorder, run by University Hospital, Montpellier.
Trial summary
The diagnosis of developmental disorders in adults is still difficult. Indeed, in France, there is not questionnaires to easily and accurately diagnose this disorder. Several diagnostic scales were developed in English. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- RAADS-R scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Dec 2015
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-specific criteria
- Collection of the informed consent (patient or legal representant)
- Affiliation or recipient with the mode of social security
- Current reading skills evaluated by completion of the fact sheet attached to the scale
- Age limits to > 18 years and < 75 years
- Specific criteria
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- Group of adult subjects with autism
- Diagnosis of autism or Asperger syndrome established within the framework of a multidisciplinary evaluation (ADOS module 4 and/or ADI) using specific international classification criteria of rare diseases (CIM 10, DSM IV-R) (F84.0 et F84.5).
- Intellectual efficiency estimated by means of a psychometric tool standardized (WAIS, WASI) greater than or equal to 85
- Subjects not denying their symptoms
- Group of adult subjects with other psychiatric
- Diagnosis of an other psychiatric trouble established according to the specific international classification criteria of mental diseases (CIM 10, DSM IV).
- absence of pervasive developmental disorder diagnosis
- Subjects not denying their symptoms
- Group of adult subjects not carriers of development and/or psychiatric disorders
Who cannot join
- Women pregnant and Breast-feeding
- Persons deprived of freedom by court order
- Specific criteria
- Group of adult subjects with autism
- Refusal of participation
- absence of autism or Asperger syndrome diagnosis
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- Group of adult subjects with other psychiatric
- Refusal of participation
- Pervasive developmental disorder diagnosis
- Group of adult subjects not carriers of development and/or psychiatric disorders
- Refusal of participation
- Diagnosis of cognitive development or psychomotor disorder, diagnosis of retard mental and/or psychiatric disorder.
About this study
Official title: Validation of the French Adaptation of the Scale Aiding in the Diagnosis of the Autism Spectrum Disorders : Scale of Asperger Syndrome Diagnosis
The diagnosis of developmental disorders in adults is still difficult. Indeed, in France, there is not questionnaires to easily and accurately diagnose this disorder. Several diagnostic scales were developed in English. Among them, RAADS-R scale, which is a clinical tool that aims to better identify autism spectrum disorders including mild forms in adult people and help to diagnose of high-functioning autism . The objective of this study is to perform a complete validation of this scale in the french version.
Read the detailed description
The diagnosis of developmental disorders in adults is still difficult. Indeed, in France, there is not questionnaires to easily and accurately diagnose this disorder. Several diagnostic scales were developed in English. Among them, RAADS-R scale, which is a clinical tool that aims to better identify autism spectrum disorders including mild forms in adult people and help to diagnose of high-functioning autism . This scale is a self-administered questionnaire completed by the person himself assisted by a clinician (psychiatrist, psychologist) which ensures the understanding of issues and the choice of answers. The scale contains 80 items including 64 questions describe specific symptoms of autism spectrum disorders and 16 questions describe non-symptomatic behaviors. The objective of this study is to perform a complete validation of this scale in the french version. 300 adults should be included, including 100 adults with high-functioning autism, 100 adults with another psychiatric disorder, and 100 adults without developmental disabilities and / or mental.
- Conditions
- Autism Spectrum Disorder
- Being tested
- RAADS-R scale
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAADS-R scaleOther
This scale is a self-administered questionnaire completed by the person himself assisted by a clinician
| Study group | Role | What they receive |
|---|---|---|
| Patients with autism disorder | Other | The RAADS-R scale is a self-administered questionnaire completed by the patient himself assisted by a clinician Receives: Other: RAADS-R scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
score at the RAADS-R scale
The scale contains 80 items including 64 questions describe specific symptoms of autism spectrum disorders and 16 questions describe non-symptomatic behaviors
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startDec 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Orange
- Responsible party
- Sponsor
- Investigators
- Amaria BAGHDADLI, MD-PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826148
- Sponsor's protocol ID
- 8747
- Acronym
- RAADS-R
- Status last verified
- Mar 2016
- First submitted
- 5 Jul 2016
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Adaptation of the Scale Aiding in the Diagnosis of the Autism Spectrum Disorders : Scale of Asperger Syndrome Diagnosis
- ClinicalTrials.gov ID
- NCT02826148
- Acronym / sponsor ID
- RAADS-R / 8747
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Fondation Orange
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Jul 2016 (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 diagnosis of developmental disorders in adults is still difficult. Indeed, in France, there is not questionnaires to easily and accurately diagnose this disorder. Several diagnostic scales were developed in English. Among them, RAADS-R scale, which is a clinical tool that aims to better identify autism spectrum disorders including mild forms in adult people and help to diagnose of high-functioning autism . The objective of this study is to perform a complete validation of this scale in the french version.
Detailed description
The diagnosis of developmental disorders in adults is still difficult. Indeed, in France, there is not questionnaires to easily and accurately diagnose this disorder. Several diagnostic scales were developed in English. Among them, RAADS-R scale, which is a clinical tool that aims to better identify autism spectrum disorders including mild forms in adult people and help to diagnose of high-functioning autism . This scale is a self-administered questionnaire completed by the person himself assisted by a clinician (psychiatrist, psychologist) which ensures the understanding of issues and the choice of answers. The scale contains 80 items including 64 questions describe specific symptoms of autism spectrum disorders and 16 questions describe non-symptomatic behaviors. The objective of this study is to perform a complete validation of this scale in the french version. 300 adults should be included, including 100 adults with high-functioning autism, 100 adults with another psychiatric disorder, and 100 adults without developmental disabilities and / or mental.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with autism disorder | Other | Other: RAADS-R scaleThe RAADS-R scale is a self-administered questionnaire completed by the patient himself assisted by a clinician |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Non-specific criteria
- Collection of the informed consent (patient or legal representant)
- Affiliation or recipient with the mode of social security
- Current reading skills evaluated by completion of the fact sheet attached to the scale
- Age limits to > 18 years and < 75 years
Key exclusion criteria (12 listed)
- Women pregnant and Breast-feeding
- Persons deprived of freedom by court order
- Specific criteria
- Group of adult subjects with autism
- Group of adult subjects with other psychiatric
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 |
|---|---|---|
| RAADS-R scaleThis scale is a self-administered questionnaire completed by the person himself assisted by a clinician | Other | Patients with autism disorder |
Primary outcome
score at the RAADS-R scale
Time frame: 15 days
The scale contains 80 items including 64 questions describe specific symptoms of autism spectrum disorders and 16 questions describe non-symptomatic behaviors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Individual participant dataSharing planned: No
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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, MD-PhD principal investigator
University Hospital, Montpellier
Questions about this trial
What is this clinical trial studying?
A study testing RAADS-R scale in people with Autism Spectrum Disorder, run by University Hospital, Montpellier.
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 15 inclusion and 12 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: finished, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score at the RAADS-R scale (time frame: 15 days). It is what the study was designed to measure, not a finding.
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 7 Jul 2016.