UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047763 |
|---|---|
| Receipt number | R000054056 |
| Scientific Title | Developing an online social skills facilitation program -- including psychological education for caregivers and teachers |
| Date of disclosure of the study information | 2022/05/16 |
| Last modified on | 2022/05/16 10:08:24 |
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Basic information
Public title
Developing an online social skills facilitation program --including psychological education for caregivers and teachers
Acronym
Online SST and Psychoeducation
Scientific Title
Developing an online social skills facilitation program -- including psychological education for caregivers and teachers
Scientific Title:Acronym
Online SST and Psychoeducation
Region
| Japan |
Condition
Condition
Autism spectrum disorder
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Children with autism spectrum disorder (ASD) have difficulty learning social skills. Traditionally, group social skills training and other programs have been implemented. However, due to the spread of COVID-19, group programs had to be discontinued or suspended. Therefore, we have been developing a "social skills learning program using an online meeting system" since 2020. However, because that program required in-person training, there were aspects of the training that made it difficult to implement the program due to the spread of the infection. In addition, considering the dissemination of the program to a diverse population, it is necessary to create a program that can be participated only online. In addition to online training for children, the program will be modified to include education for caregivers and teachers, and its usefulness will be examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scores on the Scale of Social Response Scale 2nd version(SRS-2) and Social Skills Scale before and after intervention
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
Self control
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
Online group social skills learning program for children. Once a week, 30 minutes per session, 10 sessions in total.Online psychoeducation for parents on social skills. Two sessions, 90 minutes for the first and 30 minutes for the second.Psychoeducation for teachers on social skills by viewing videos, 5 minutes per session, 4 sessions in total.
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
Having an Autism Spectrum Disorder diagnosis
First through sixth grades of elementary school
Key exclusion criteria
Verbal IQ of less than 70 on the Wechsler Intelligence Test for Children, 4th Edition
Secondary problems that make group participation difficult.
Receiving professional social skills training at another institution during the period of study participation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yamamoto |
| Middle name | TOMOKA |
| Last name | Tomoka |
Organization
Osaka University
Division name
Department of Pediatrics, Graduate School of Medicine
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 | Yamamoto |
| Middle name | TOMOKA |
| Last name | Tomoka |
Organization
Osaka University
Division name
Department of Pediatrics, Graduate School of Medicine
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
Japan Science and Technology Agency
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
0662108289
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
| 2022 | Year | 05 | Month | 16 | 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
| 2022 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 04 | 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
| 2022 | Year | 05 | Month | 16 | Day |
Last modified on
| 2022 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054056
| Research Plan | |
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| 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 |
