The Development of a Screening Questionnaire to Discriminate Autism Spectrum Disorder and Schizotypal Disorder, and Validation of the Danish Version of RAADS-R

Autism Spectrum Disorder Clinical Trial

— ZA-RAA  

Official title:

The Development of a Screening Questionnaire to Discriminate Autism Spectrum Disorder and Schizotypal Disorder, and Validation of the Danish Version of RAADS-R

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05213286
• Other study ID #: ZA-RAA
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease
• Schizotypal Disorder
• Schizotypal Personality Disorder

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