UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042581 |
|---|---|
| Receipt number | 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 | 2023/11/30 09:24:10 |
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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
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
t-yamamoto@kokoro.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
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
No longer recruiting
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
| 2023 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048592
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
