UMIN-CTR Clinical Trial

Basic information
Public title	Developing the program of social skills enhancement using online meeting system
Acronym	Developing the online program of SST
Scientific Title	Developing the program of social skills enhancement using online meeting system
Scientific Title:Acronym	Developing the online program of SST
Region	Japan

Condition
Condition	Autism Spectrum Disorders
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Children with Autism Spectrum Disorder (ASD) have difficulty of acquisition of social skills training. Group social skills trainings are conducted to enhancement of social skills. But because of spreading of COVID-19, many group trainings that children couldn't be avoided closure and cohesive needed to be discontinued. We test the effectiveness of social skills program using online meeting system for elementary school children with high-functioning ASD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Social Responsive Scale 2nd edition
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Social skills program contains the lecture using online meeting system (Online lecture) and face to face rehearsal. One group has capacity of 4 persons. Online lecture session: Children take a lessons by clinical psychologists at home. They study five theme over several days. Face to face session: Children do behavioral rehearsal of theme that they studied at online lecture. Online lecture sessions and face to face sessions repeat 2 times. Contents of learning focus on the communication skills of social skills.
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	12 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients of Developmental Disorders clinic of Osaka University Hospital.
Key exclusion criteria	Verval IQ<70 Secondary problems that are difficult to participate in group program Receiving a professional training related social skills during participating in this study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name TOMOKA Middle name Last name YAMAMOTO
Organization	Osaka University Graduate of Medicine
Division name	Pediatrics
Zip code	5650871
Address	2-2 Yamadaoka Suita-city, Osaka
TEL	0668793863
Email	t-yamamoto@kokoro.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name TOMOKA Middle name Last name YAMAMOTO
Organization	Osaka University Graduate of Medicine
Division name	Pediatrics
Zip code	5650871
Address	2-2 Yamadaoka Suita-city, Osaka
TEL	0668793863
Homepage URL
Email	t-yamamoto@kokoro.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	JST Center of Inovation Program
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka University Clinical Research Review Committee
Address	2-2 Yamadaoka Suita-city, Osaka
Tel	0662108296
Email	t-yamamoto@kokoro.med.osaka-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	2020 Year 08 Month 17 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	Enrolling by invitation
Date of protocol fixation	2020 Year 07 Month 07 Day
Date of IRB	2020 Year 08 Month 18 Day
Anticipated trial start date	2020 Year 08 Month 18 Day
Last follow-up date	2025 Year 08 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 17 Day
Last modified on	2020 Year 11 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046837