UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047763
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email t-yamamoto@kokoro.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

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
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
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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054056

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.