NCT05213286

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

1.6 years

First QC Date

January 3, 2022

Last Update Submit

March 15, 2022

Conditions

Autism Spectrum DisorderSchizotypal Disorder

Outcome Measures

Primary Outcomes (2)

  • ZAQ

    schiZotypy Autism Questionnaire

    up to 1 month

  • RAADS-R-DK

    Ritvo Autism Asperger Diagnostic Scale-Revised-Danish version

    Up to 1 month

Secondary Outcomes (3)

  • AQ

    Up to 1 month

  • WHO-DAS 2.0

    Up to 1 month

  • WHO-5

    Up to 1 month

Study Arms (1)

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

OTHER

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

Interventions

Application of ZAQ and RAADS-R-DKDIAGNOSTIC_TEST

Test of the questionnaires in each of the three groups.

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glostrup University Hospital

Copenhagen, 2605, Denmark

RECRUITING

Related Publications (2)

  • Parvaiz R, Vindbjerg E, Crespi B, Happe F, Schalbroeck R, Al-Sayegh Z, Danielsen IM, Tonge B, Videbech P, Abu-Akel A. Protocol for the development and testing of the schiZotypy Autism Questionnaire (ZAQ) in adults: a new screening tool to discriminate autism spectrum disorder from schizotypal disorder. BMC Psychiatry. 2023 Mar 28;23(1):200. doi: 10.1186/s12888-023-04690-3.

    PMID: 36978026DERIVED

  • Parvaiz R, Al-Sayegh Z, Jacobsen PK, Danielsen IM, Videbech P. Validation of a screening tool for autism spectrum disorder in adults - a study protocol. Dan Med J. 2022 Nov 23;69(12):A02220118.

    PMID: 36458608DERIVED

MeSH Terms

Conditions

Autism Spectrum DisorderSchizotypal Personality Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersPersonality Disorders

Central Study Contacts

rizwan parvaiz

CONTACT

+4571313030rizwan.parvaiz@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor, Director of Autism Research

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 28, 2022

Study Start

February 1, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

March 16, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)