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

Autism Spectrum Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02826148
• Other study ID #: 8747
• Status: Completed
• Phase: N/A
• First received: July 5, 2016
• Last updated: July 5, 2016
• Start date: December 2011
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Asperger Syndrome
• Autism Spectrum Disorder
• Child Development Disorders, Pervasive

Intervention

Other:
• RAADS-R scale
This scale is a self-administered questionnaire completed by the person himself assisted by a clinician

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Fondation Orange

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	15 days	No