UMIN-CTR Clinical Trial

Basic information
Public title	Preliminary exploration for social behavior during group activities in autism spectrum disorder
Acronym	Preliminary exploration for social behavior during group activities in autism spectrum disorder
Scientific Title	Preliminary exploration for social behavior during group activities in autism spectrum disorder
Scientific Title:Acronym	Preliminary exploration for social behavior during group activities in autism spectrum disorder
Region	Japan

Condition
Condition	Autism spectrum disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Exploration for social behavior during group activities in autism spectrum disorders
Basic objectives2	Others
Basic objectives -Others	Development of estimation methods of social skills
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analyzing moving images of group activities
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Individuals with autism spectrum disorder or schizophrenia
Key exclusion criteria	Individuals who are judged as unfit for this research by their doctor
Target sample size	18

Research contact person
Last name of lead principal investigator	1st name Haruhisa Middle name Last name Ohta
Organization	Showa University
Division name	Medical Institute of Developmental Disabilities Research
Zip code	157-8577
Address	6-11-11 Kitakarasuyama,Setagaya-ku,Tokyo, Japan
TEL	03-3300-5231
Email	haruhisap@med.showa-u.ac.jp

Public contact
1st name of contact person	1st name Haruhisa Middle name Last name Ohta
Organization	Showa University
Division name	Medical Institute of Developmental Disabilities Research
Zip code	157-8577
Address	6-11-11 Kitakarasuyama,Setagaya-ku,Tokyo, Japan
TEL	03-3300-5231
Homepage URL
Email	haruhisap@med.showa-u.ac.jp

Sponsor
Institute	Showa University
Institute
Department

Funding Source
Organization	Medical Institute of Developmental Disabilities Research, Showa University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	lnstitutional Review Board of ShowaUniversity Karasuyama Hospital
Address	6-11-11 Kitakarasuyama,Setagaya-ku,Tokyo, Japan
Tel	03-3300-5231
Email	showa-crc@ofc.showa-u.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	2022 Year 04 Month 01 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	2019 Year 04 Month 15 Day
Date of IRB	2019 Year 02 Month 08 Day
Anticipated trial start date	2019 Year 05 Month 15 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Analyzing moving images of group activities for autism spectrum disorder

Management information
Registered date	2019 Year 04 Month 03 Day
Last modified on	2019 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041461