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)
Primary Purpose
Autism Spectrum Disorder, Schizotypal Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Application of ZAQ and RAADS-R-DK
Sponsored by
About this trial
This is an interventional diagnostic trial for Autism Spectrum Disorder
Eligibility Criteria
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
Sites / Locations
- Glostrup University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients referred for assessment of ASD, non-ASD psychiatric patients and control group
Arm Description
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
Outcomes
Primary Outcome Measures
ZAQ
schiZotypy Autism Questionnaire
RAADS-R-DK
Ritvo Autism Asperger Diagnostic Scale-Revised-Danish version
Secondary Outcome Measures
AQ
Autism Quotient
WHO-DAS 2.0
Assessment instrument for health and disability.
WHO-5
Assessment of psychological well-being
Full Information
NCT ID
NCT05213286
First Posted
January 3, 2022
Last Updated
March 15, 2022
Sponsor
Glostrup University Hospital, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT05213286
Brief Title
The Development of a Screening Questionnaire to Discriminate Autism Spectrum Disorder and Schizotypal Disorder, and Validation of the Danish Version of RAADS-R
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glostrup University Hospital, Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Schizotypal Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients referred for assessment of ASD, non-ASD psychiatric patients and control group
Arm Type
Other
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Application of ZAQ and RAADS-R-DK
Intervention Description
Test of the questionnaires in each of the three groups.
Primary Outcome Measure Information:
Title
ZAQ
Description
schiZotypy Autism Questionnaire
Time Frame
up to 1 month
Title
RAADS-R-DK
Description
Ritvo Autism Asperger Diagnostic Scale-Revised-Danish version
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
AQ
Description
Autism Quotient
Time Frame
Up to 1 month
Title
WHO-DAS 2.0
Description
Assessment instrument for health and disability.
Time Frame
Up to 1 month
Title
WHO-5
Description
Assessment of psychological well-being
Time Frame
Up to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
rizwan parvaiz
Phone
+4571313030
Email
rizwan.parvaiz@regionh.dk
Facility Information:
Facility Name
Glostrup University Hospital
City
Copenhagen
ZIP/Postal Code
2605
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rizwan Parvaiz
Phone
+4571313030
Email
rizwan.parvaiz@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Development of a Screening Questionnaire to Discriminate Autism Spectrum Disorder and Schizotypal Disorder, and Validation of the Danish Version of RAADS-R
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