UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038409 |
|---|---|
| Receipt number | R000042541 |
| Scientific Title | A study on the usefulness of a communication program for people with autism spectrum disorder using a Web conferencing services |
| Date of disclosure of the study information | 2019/10/29 |
| Last modified on | 2020/01/30 12:36:59 |
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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
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
jm-tomari@kochi-u.ac.jp
Sponsor or person
Institute
kochi medical school
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042541
