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

NCT ID: NCT05213286

Last Updated: 2022-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-08-31

Brief Summary

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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

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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.

Conditions

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Autism Spectrum Disorder Schizotypal Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Application of ZAQ and RAADS-R-DK

Intervention Type DIAGNOSTIC_TEST

Test of the questionnaires in each of the three groups.

Interventions

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Application of ZAQ and RAADS-R-DK

Test of the questionnaires in each of the three groups.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Rizwan Parvaiz

Medical doctor, Director of Autism Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Glostrup University Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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rizwan parvaiz

Role: CONTACT

+4571313030

Facility Contacts

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Rizwan Parvaiz

Role: primary

+4571313030

References

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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.

Reference Type DERIVED
PMID: 36978026 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36458608 (View on PubMed)

Other Identifiers

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ZA-RAA

Identifier Type: -

Identifier Source: org_study_id

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