UMIN-CTR Clinical Trial

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