UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041437 |
|---|---|
| Receipt number | R000046837 |
| Scientific Title | Developing the program of social skills enhancement using online meeting system |
| Date of disclosure of the study information | 2020/08/17 |
| Last modified on | 2020/11/27 10:40:24 |
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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
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
t-yamamoto@kokoro.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046837
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| Registered date | File name |
| Research case data | |
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