- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02826148
Validation of the French Adaptation of the RAADS-R Scale : Scale of Asperger Syndrome Diagnosis (RAADS-R)
July 5, 2016 updated by: University Hospital, Montpellier
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
324
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
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
Exclusion Criteria:
- 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
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patients with autism disorder
The RAADS-R scale is a self-administered questionnaire completed by the patient himself assisted by a clinician
|
This scale is a self-administered questionnaire completed by the person himself assisted by a clinician
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Amaria BAGHDADLI, MD-PhD, University Hospital, Montpellier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
July 5, 2016
First Submitted That Met QC Criteria
July 5, 2016
First Posted (Estimate)
July 7, 2016
Study Record Updates
Last Update Posted (Estimate)
July 7, 2016
Last Update Submitted That Met QC Criteria
July 5, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8747 (Other Identifier: CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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