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

Sponsor

Glostrup University Hospital, Copenhagen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05213286

Collaborator

(none)

600

Enrollment

Location

Arm

18.9

Anticipated Duration (Months)

31.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder Schizotypal Disorder	Diagnostic Test: Application of ZAQ and RAADS-R-DK	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients referred for assessment of ASD, non-ASD psychiatric patients and control group All three groups will be tested with RAADS-R-DK and ZAQ. The results from these diagnostic tests will be compared to gold standard clinical assessments in specialized multidisciplinary teams	Diagnostic Test: Application of ZAQ and RAADS-R-DK Test of the questionnaires in each of the three groups.

Arm

Intervention/Treatment

Other: Patients referred for assessment of ASD, non-ASD psychiatric patients and control group

All three groups will be tested with RAADS-R-DK and ZAQ. The results from these diagnostic tests will be compared to gold standard clinical assessments in specialized multidisciplinary teams

Diagnostic Test: Application of ZAQ and RAADS-R-DK

Test of the questionnaires in each of the three groups.

Outcome Measures

Primary Outcome Measures

ZAQ [up to 1 month]
schiZotypy Autism Questionnaire
RAADS-R-DK [Up to 1 month]
Ritvo Autism Asperger Diagnostic Scale-Revised-Danish version

Secondary Outcome Measures

AQ [Up to 1 month]
Autism Quotient
WHO-DAS 2.0 [Up to 1 month]
Assessment instrument for health and disability.
WHO-5 [Up to 1 month]
Assessment of psychological well-being

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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)
WAIS > 85, or Raven or no-clinical suspicion and education level of 11 years or above
Completion of
Clinical assessment
Adult Asperger Assessment (AAA)
Psychopathology evaluation using DSM-V
A conclusion based on interdisciplinary consensus

Exclusion Criteria:

Insufficient Danish language skills
Acute psychiatric illness prompting departure/dismissal from the diagnostic assessment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Glostrup University Hospital	Copenhagen		Denmark	2605

Sponsors and Collaborators

Glostrup University Hospital, Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rizwan Parvaiz, Medical doctor, Director of Autism Research, Glostrup University Hospital, Copenhagen

ClinicalTrials.gov Identifier:

NCT05213286

Other Study ID Numbers:

ZA-RAA

First Posted:

Jan 28, 2022

Last Update Posted:

Mar 16, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Disease

Autistic Disorder

Autism Spectrum Disorder

Child Development Disorders, Pervasive

Schizotypal Personality Disorder

Study Results

No Results Posted as of Mar 16, 2022