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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042581
Receipt No. R000048592
Scientific Title Social Skills intervention for children with Autism Spectrum Disorder
Date of disclosure of the study information 2020/11/30
Last modified on 2020/11/27

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Basic information
Public title Social Skills intervention for children with Autism Spectrum Disorder
Acronym SST for Children with ASD
Scientific Title Social Skills intervention for children with Autism Spectrum Disorder
Scientific Title:Acronym SST for Children with ASD
Region
Japan

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

Objectives
Narrative objectives1 Measuring the effects of social skills intervention to high-functioning children's with ASD and their parents and clarifying the learning process
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Social skills scale at pre-intervention and post-intervention
Key secondary outcomes Behavioral data by BMS
SRS
CBCL
The friendship Qualities Scale
P-Fstudy
Competence scale for children
FFFS
CISS
POMS

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 The program consists of 10 sessions for 6 months. One session takes from an hour to one and a half hours, and the maximum number of participants is 5. 2 clinical psychologists and 3 staff participate. Program contents are aimed at developing communication skills (Conversation, Verbal expression et al), developing social skills (interaction with peers, corporation et al).
Interventions/Control_2 No intervention (Treatment as usual).
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 Elementary school children with a diagnosis of ASD at Osaka University Hospital.
Key exclusion criteria Verbal IQ<70
Parent or child has psychiatric symptoms
Target sample size 150

Research contact person
Name of lead principal investigator
1st name TOMOKA
Middle name TOMOKA
Last name YAMAMOTO
Organization Graduate school of Medicine, Osaka University
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 Graduate school of Medicine, Osaka University
Division name Pediatrics
Zip code 565-0871
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
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 rinri@hp-crc.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 11 Month 30 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
2010 Year 02 Month 06 Day
Date of IRB
2010 Year 02 Month 14 Day
Anticipated trial start date
2010 Year 06 Month 05 Day
Last follow-up date
2022 Year 06 Month 30 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 11 Month 27 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=R000048592

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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