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

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder; Schizotypal Disorder
• Intervention / Treatment: Diagnostic test: Application of ZAQ and RAADS-R-DK

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 Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rizwan Parvaiz; Phone Number: +4571313030; Email: rizwan.parvaiz@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2605
    • Recruiting
    • Glostrup University Hospital
    • Contact: Rizwan Parvaiz; Phone Number: +4571313030; Email: rizwan.parvaiz@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ZAQ	schiZotypy Autism Questionnaire	up to 1 month
RAADS-R-DK	Ritvo Autism Asperger Diagnostic Scale-Revised-Danish version	Up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AQ	Autism Quotient	Up to 1 month
WHO-DAS 2.0	Assessment instrument for health and disability.	Up to 1 month
WHO-5	Assessment of psychological well-being	Up to 1 month

Collaborators and Investigators

• Sponsor: Glostrup University Hospital, Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 15, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Neurodevelopmental Disorders; Disease; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Schizotypal Personality Disorder
• Other Study ID Numbers: ZA-RAA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No