NCT02826148

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
Last Updated

July 7, 2016

Status Verified

March 1, 2016

Enrollment Period

4 years

First QC Date

July 5, 2016

Last Update Submit

July 5, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients with autism disorder

OTHER

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

Other: RAADS-R scale

Interventions

This scale is a self-administered questionnaire completed by the person himself assisted by a clinician

Patients with autism disorder

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Amaria BAGHDADLI, MD-PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2016

First Posted

July 7, 2016

Study Start

December 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 7, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share