UMIN-CTR Clinical Trial

Basic information
Public title	A study on the usefulness of a communication program for people with autism spectrum disorder using a Web conferencing services
Acronym	A study on the usefulness of a communication program for people with autism spectrum disorder using a Web conferencing services
Scientific Title	A study on the usefulness of a communication program for people with autism spectrum disorder using a Web conferencing services
Scientific Title:Acronym	A study on the usefulness of a communication program for people with autism spectrum disorder using a Web conferencing services
Region	Japan

Condition
Condition	autism spectrum disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	People with autism spectrum disorder (ASD) lack the inherent ability to automatically read the atmosphere in a room, respond to it, or to enjoy social interaction (this is why ASD is categorized as a condition in which theory of the mind is not functioning). As a result, people with ASD have difficulty forming interpersonal relationships and they often have secondary disorders. In addition, drug therapy for ASD is symptomatic treatment, so people with ASD need psychosocial support. Training in communication skills and socializing is an extremely vital part of that support. A communication program for adults with ASD was developed at Showa University is Karasuyama Hospital as a standardized therapy, and this program has yielded results. The program is conducted in a total of 20 weekly sessions. That said, the traffic network in Kochi Prefecture is lacking in comparison to that in urban areas, and participants often have difficulty visiting the hospital weekly. Given these facts, needs could potentially be met by providing a Web-based communication program for people with ASD. Accordingly, this study is exploring the feasibility of such a program. The Internet has clearly permeated society. According to a Ministry of Internal Affairs and Communications survey, there were over 100 million Internet users in Japan in 2017, and over 90 percent of people ages 13-59 use the Internet. A remote intervention using the Internet avoids geographical constraints, which makes it advantageous as a support option. This intervention can be performed if a subject is connected to the Internet. However, no studies have examined an online communication program for people with ASD. The aim of this study is to examine the feasibility of an online program. In addition, this study seeks to compare the effectiveness of the program to that of a conventional face-to-face program.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Interpersonal Reactivity Index Japanese version(It is before and after intervention)
Key secondary outcomes	Autism Spectrum Question(It is before and after intervention) WHO Quality of Life 26(It is before and after intervention) social functioning scale japanese version(It is before and after intervention) General Self Esteem Score(It is before and after intervention) a survey(It is before and after intervention) wechsler adult intelligence scale-third edutuon Social Communication Questionnaire(It is before and after intervention) Grobal Assessment of Functioning Scale(It is before and after intervention)

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	Subjects will be adults who meet the inclusion criteria and who consent to participate in this study.A communication program will be conducted as part of zoom.The program will be conducted in weekly sessions of about an hour and a half.One round of the program will last 5 months,for a total of 20 sessions.A group will consist of up to 5 individuals. A communication program for adults on the autism spectrum The Ministry of Health,Labour and Welfare is 2014 Project to Promote Comprehensive Welfare for Persons with Disabilities at Showa University Karasuyama Hospital indicated:1.that the program was effective,2.that characteristics of autism were alleviated after participation in the program,3.that participants communicated more,and 4.that the program may improve quality of life for participants. Procedures for this study Subjects will be adults who meet the inclusion criteria and who consent to participate in this study. A questionnaire (AQ, SFS-J, IRI-J and a WHOQOL26,GSES,a survey) will be distributed to subjects for them to complete, intake interviews will be conducted, and the SCQ will be administered to a person who brings up a patient or a partner. The WAIS-3 will be administered They install zoom I transmit a message on the communication program day before Sessions will be conducted weekly for about an hour and a half They log in at designation time.A session will consist of a starting meeting, submission and checking of homework, confirmation of what the program entails (confirmation of what the program entails and an explanation of rules, specification of a set topic for each session, and previous homework), and a farewell meeting Once all 20 sessions end, a questionnaire will be distributed to subjects for them to complete (AQ, SFS-J, IRI-J and a WHOQOL26,GSES,a survey, and a survey after all of the sessions have ended), and the SCQ will be administered to a person who brings up a patient or a partner.
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	18 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	Outpatients who have been diagnosed with autism spectrum disorder Individuals diagnosed with an autism spectrum disorder Individuals should ages 18-50 Both sexes may participate Individuals with stable comorbidities and individuals whose medication has changed little up to 1 month prior to enrollment (Global Assessment of Functioning (GAF) score of 51 or higher) Individuals who are connected to the Internet
Key exclusion criteria	Individuals with intense suicidal ideation or individuals with a mental state (secondary disorder) hampering an understanding of this study Individuals who were severely injured within the past 3 months Individuals with an unstable condition who are likely to be hospitalized (GAF score below 50)
Target sample size	15

Research contact person
Name of lead principal investigator	1st name yukiko Middle name Last name tomari
Organization	kochi medical school
Division name	department of neuropsychiatry(rehabilitation center)
Zip code	780-8072
Address	kohasu oko-cho,nankoku,kochi 783-8505
TEL	088-880-2359
Email	jm-tomari@kochi-u.ac.jp

Public contact
Name of contact person	1st name yukiko Middle name Last name tomari
Organization	kochi medical school
Division name	department of neuropsychiatry(rehabilitation center)
Zip code	780-8072
Address	kohasu oko-cho,nankoku,kochi 783-8505
TEL	088-880-2359
Homepage URL
Email	jm-tomari@kochi-u.ac.jp

Sponsor
Institute	kochi medical school
Institute
Department

Funding Source
Organization	no
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	kochi medical school
Address	kohasu oko-cho,nankoku,kochi 783-8505
Tel	088-880-2359
Email	jm-tomari@kochi-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	2019 Year 10 Month 29 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	2019 Year 10 Month 29 Day
Date of IRB
Anticipated trial start date	2019 Year 11 Month 30 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 28 Day
Last modified on	2020 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042541