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Validation of the French Adaptation of the RAADS-R Scale : Scale of Asperger Syndrome Diagnosis (RAADS-R)

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
RAADS-R scale
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Autism Spectrum Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Patients with autism disorder

    Arm Description

    The RAADS-R scale is a self-administered questionnaire completed by the patient himself assisted by a clinician

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    July 5, 2016
    Last Updated
    July 5, 2016
    Sponsor
    University Hospital, Montpellier
    Collaborators
    Fondation Orange
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02826148
    Brief Title
    Validation of the French Adaptation of the RAADS-R Scale : Scale of Asperger Syndrome Diagnosis
    Acronym
    RAADS-R
    Official Title
    Validation of the French Adaptation of the Scale Aiding in the Diagnosis of the Autism Spectrum Disorders : Scale of Asperger Syndrome Diagnosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2011 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Montpellier
    Collaborators
    Fondation Orange

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    324 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with autism disorder
    Arm Type
    Other
    Arm Description
    The RAADS-R scale is a self-administered questionnaire completed by the patient himself assisted by a clinician
    Intervention Type
    Other
    Intervention Name(s)
    RAADS-R scale
    Intervention Description
    This scale is a self-administered questionnaire completed by the person himself assisted by a clinician
    Primary Outcome Measure Information:
    Title
    score at the RAADS-R scale
    Description
    The scale contains 80 items including 64 questions describe specific symptoms of autism spectrum disorders and 16 questions describe non-symptomatic behaviors
    Time Frame
    15 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amaria BAGHDADLI, MD-PhD
    Organizational Affiliation
    University Hospital, Montpellier
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Validation of the French Adaptation of the RAADS-R Scale : Scale of Asperger Syndrome Diagnosis

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