UMIN-CTR Clinical Trial

Basic information
Public title	Study on the validity of conducting Autism Diagnostic Observation Schedule Second Edition (ADOS-2) while wearing a mask
Acronym	Validation study of ADOS-2 evaluation while wearing a mask
Scientific Title	Study on the validity of conducting Autism Diagnostic Observation Schedule Second Edition (ADOS-2) while wearing a mask
Scientific Title:Acronym	Validation study of ADOS-2 evaluation while wearing a mask
Region	Japan

Condition
Condition	Autism Spectrum Disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate the diagnostic validity of conducting the second edition of the Autism Diagnosis Observation Scale (ADOS-2) for the patients with autism spectrum disorder and Normal development children while wearing a mask as the primary endpoint.
Basic objectives2	Others
Basic objectives -Others	Diagnostic Validity
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Algorithm scores of the second edition of the Autism Diagnosis Observation Scale (ADOS-2) evaluation while wearing a mask
Key secondary outcomes	Scores of each rating item of the second edition of the Autism Diagnosis Observation Scale (ADOS-2), Scores of the Parent-interview Autism Spectrum Disorder Rating Scale-Text Revision, Full-scale Intelligence Quotient of the Wechsler Intelligence Scale for Children-Fourth Edition

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	6 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Disease: Those who meet the diagnostic criteria for autism spectrum disorder in DSM-5 (2) Age: 1st grade of elementary school to 3rd grade of junior high school (when ADOS-2 is implemented) (3) Those who meet the standards of language level that ADOS-2 Module 3 (for elementary and junior high school students) can implement Control group (1) Those who are not diagnosed with autism spectrum disorder (those who do not have major problems in interpersonal interaction on a daily basis and do not meet the diagnosis of autism spectrum disorder in DSM-5) (2) 1st grade of elementary school to 3rd grade of junior high school (when ADOS-2 is implemented) (3) Those who meet the standards of language level that ADOS-2 Module 3 (for elementary and junior high school students) can implement
Key exclusion criteria	(1) Those whose parents do not provide consent to participate in this research (2) Those who do not provide consent to participate in this research (3) Those who have difficulty in implementing ADOS-2 due to physical illness, movement disorder, etc. (4) Those whose full-scale IQ of WISC-IV is less than 70
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Tomita
Organization	Graduate School of Medicine, Tohoku University
Division name	Department of Psychiatry
Zip code	980-8574
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7262
Email	htomita@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Moe Middle name Last name Seto
Organization	Tohoku University Hospital
Division name	Department of Psychiatry
Zip code	980-8574
Address	2-1 Seiryo, Aoba-ku, Sendai
TEL	0227177262
Homepage URL
Email	htomita@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Medicine, Department of Psychiatry
Institute
Department

Funding Source
Organization	Others
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Tohoku University

IRB Contact (For public release)
Organization	the Ethical Committee of Tohoku University Graduate School of Medicine
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
Tel	022-717-7262
Email	htomita@med.tohoku.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 08 Month 14 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2021 Year 08 Month 05 Day
Date of IRB	2021 Year 08 Month 05 Day
Anticipated trial start date	2021 Year 08 Month 10 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	ADOS-2: A semi-structured observational test for the assessment of autism spectrum disorders. It is conducted one-on-one between the inspector and the children to be inspected in the interview room. The subject plays with toys and works on simple tasks, and the inspector evaluates how the subject communicates with the inspector during that time.

Management information
Registered date	2021 Year 08 Month 10 Day
Last modified on	2021 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051540