UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045118
Receipt number R000051540
Scientific Title Study on the validity of conducting Autism Diagnostic Observation Schedule Second Edition (ADOS-2) while wearing a mask
Date of disclosure of the study information 2021/08/14
Last modified on 2021/08/10 21:31:12

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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 or person

Institute

Tohoku University Graduate School of Medicine, Department of Psychiatry

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051540


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name