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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05213286
Other study ID # ZA-RAA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date August 31, 2023

Study information

Verified date March 2022
Source Glostrup University Hospital, Copenhagen
Contact rizwan parvaiz
Phone +4571313030
Email rizwan.parvaiz@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to investigate the validity, reliability and clinical features of a Danish version of the Ritvo Autism Asperger Diagnostic Scale-Revised (RAADS-R). A self-reporting scale devise used as a supplementary questionnaire in diagnosing autism spectrum disorder (ASD) in adults. Furthermore the validity of novel screening questionnaire: SchiZotypal Autism Questionnaire (ZAQ), will be investigated. ZAQ is developed to discriminate Schizotypal Disorder from ASD.


Description:

The study has 2 parts. Part 1: The objective is to develop and validate a self-report screening questionnaire to efficiently discriminate between Schizotypal Disorder (SD) and Autism Spectrum Disorder (ASD) within the adult population. Discriminating ASD from SD in a clinical setting is a complex and time-consuming task, as they share considerable features both at the symptomatic and the diagnostic criteria. A pilot version of this questionnaire have been developed with 139 questions and named schiZotypy Autism Questionnaire (ZAQ), to discriminate between these conditions. Part 2: RAADS-R scale, which is a clinical tool that aims to better identify autism spectrum disorders The scale is a self-administered questionnaire completed by the patient 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 to describe non-symptomatic behaviors. The objective of this study is to perform a complete validation of this scale in a Danish translation. For both parts of the study 600 adults will be included, 200 adults referred for assessment of autism, 200 adults with another psychiatric disorder, and 200 adults without psychiatric disease.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Al patient referred to the outpatient clinic for ADHD and Autism at PCG, in the research period, for diagnostic assessment of Autism Spectrum Disorder (Pervasive Developmental Disorder, infantile autism, atypical autism and Asperger Syndrome) 2. WAIS > 85, or Raven or no-clinical suspicion and education level of 11 years or above 3. Completion of 1. Clinical assessment 2. Adult Asperger Assessment (AAA) 3. Psychopathology evaluation using DSM-V 4. A conclusion based on interdisciplinary consensus Exclusion Criteria: 1. Insufficient Danish language skills 2. Acute psychiatric illness prompting departure/dismissal from the diagnostic assessment

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Application of ZAQ and RAADS-R-DK
Test of the questionnaires in each of the three groups.

Locations

Country Name City State
Denmark Glostrup University Hospital Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary ZAQ schiZotypy Autism Questionnaire up to 1 month
Primary RAADS-R-DK Ritvo Autism Asperger Diagnostic Scale-Revised-Danish version Up to 1 month
Secondary AQ Autism Quotient Up to 1 month
Secondary WHO-DAS 2.0 Assessment instrument for health and disability. Up to 1 month
Secondary WHO-5 Assessment of psychological well-being Up to 1 month
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