Autism Spectrum DisorderZA-RAANCT05213286
The Development of a Screening Questionnaire to Discriminate Autism Spectrum Disorder and Schizotypal Disorder, and Validation of the Danish Version of RAADS-R
A study testing Application of ZAQ and RAADS-R-DK in people with Autism Spectrum Disorder and Schizotypal Disorder, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Schizotypal Disorder
- What is being tested?
- Application of ZAQ and RAADS-R-DK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Insufficient Danish language skills
- Acute psychiatric illness prompting departure/dismissal from the diagnostic assessment
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Glostrup University Hospital
Copenhagen, 2605
Rizwan Parvaiz, +4571313030, rizwan.parvaiz@regionh.dk
About this study
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Schizotypal Disorder
- Being tested
- Application of ZAQ and RAADS-R-DK
- Medical subject headings
- Autism Spectrum Disorder, Schizotypal Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of ZAQ and RAADS-R-DKDiagnostic test
Test of the questionnaires in each of the three groups.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Application of ZAQ and RAADS-R-DK |
What is being measured
The primary outcome is the main question the study is designed to answer.
ZAQ
schiZotypy Autism Questionnaire
Measured: up to 1 month
RAADS-R-DK
Ritvo Autism Asperger Diagnostic Scale-Revised-Danish version
Measured: Up to 1 month
Secondary outcomes (3)
AQ
Autism Quotient
Measured: Up to 1 month
WHO-DAS 2.0
Assessment instrument for health and disability.
Measured: Up to 1 month
WHO-5
Assessment of psychological well-being
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Feb 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rizwan Parvaiz, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213286
- Sponsor's protocol ID
- ZA-RAA
- Acronym
- ZA-RAA
- Status last verified
- Mar 2022
- First submitted
- 3 Jan 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36978026Parvaiz 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.
PubMed 36458608
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05213286
- Acronym / sponsor ID
- ZA-RAA / ZA-RAA
- Conditions
- Autism Spectrum Disorder, Schizotypal Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients referred for assessment of ASD, non-ASD psychiatric patients and control group | Other | Diagnostic Test: Application of ZAQ and RAADS-R-DKAll 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Insufficient Danish language skills
- Acute psychiatric illness prompting departure/dismissal from the diagnostic assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of ZAQ and RAADS-R-DKTest of the questionnaires in each of the three groups. | Diagnostic test | Patients referred for assessment of ASD, non-ASD psychiatric patients and control group |
Primary outcome
ZAQ
Time frame: up to 1 month
schiZotypy Autism Questionnaire
RAADS-R-DK
Time frame: Up to 1 month
Ritvo Autism Asperger Diagnostic Scale-Revised-Danish version
3 secondary outcomes
AQ
Time frame: Up to 1 month
WHO-DAS 2.0
Time frame: Up to 1 month
WHO-5
Time frame: Up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Derived from this study: PubMed 36978026Parvaiz 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.
- Derived from this study: PubMed 36458608Parvaiz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of ZAQ and RAADS-R-DK in people with Autism Spectrum Disorder and Schizotypal Disorder, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rizwan parvaiz (+4571313030, rizwan.parvaiz@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ZAQ (time frame: up to 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05213286, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.