UMIN-CTR Clinical Trial

Basic information
Public title	Effect to other mental diseases in the autism spectrum disorder communication program
Acronym	Effect to other mental diseases in the ASD communication program
Scientific Title	Effect to other mental diseases in the autism spectrum disorder communication program
Scientific Title:Acronym	Effect to other mental diseases in the ASD communication program
Region	Japan

Condition
Condition	psychiatric disorder except autistic spectrum disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Communication is an important activity that forms the bedrock of social interaction. Individuals with a mental disorder like schizophrenia are often deeply concerned about communicating because of the characteristics of that disorder. Accordingly, numerous studies have dealt with communication through approaches such as social skills training (SST). In fact, many patients in psychiatric occupational therapy have difficulty interacting with others, conveying their feelings, and understanding the feelings of others. The applicant explored whether a beneficial group program could be devised, and that led to discovery of a communication program for adults on the autism spectrum that was developed by Showa University Karasuyama Hospital. The program is specifically for adults with autism spectrum disorder. Nonetheless, much of the program content matches the characteristics of communication and concerns of individuals encountered in clinical settings. In light of these facts, the applicant posited that the program might also benefit individuals with a mental disorder who are concerned about communicating. The aim of the current study is to ascertain how effective a communication program for adults on the autism spectrum would be for individuals with some other psychiatric disorder.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Social Functioning Scale Japanese version SFS-J(It is before and after intervention)
Key secondary outcomes	Autism Spectrum Question AQ(It is before and after intervention) WHO Quality of Life 26(It is before and after intervention) Interpersonal Reactivity Index Japanese version(It is before and after intervention) State-Trait Anxiety Inventory(It is before and after intervention) General Self Esteem Score(It is before and after intervention) brief psychiatoric rating scale BPRS(once a month) wechsler adult intelligence scale-third edutuon WAIS-3 Questionnaire(It is before and after intervention) Achievement list every session,achievement list of the homework

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	A communication program will be conducted as part of outpatient psychiatric occupational therapy. 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 8 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 1.Potential subjects will be verified as having a certain level of basic skills(one of the 6 subscales of the KiSS-18)and a certain AQ, GAF consent to study participation will be obtained 2.A questionnaire(SFS-J,STAI,IRI-J,WHOQOL26,GSES, and a survey)will be distributed to subjects for them to complete, intake interviews will be conducted, and the BPRS will be administered 3.The WAIS-third will be administered 4. A session will consist of a starting meeting(a 1-minute speech), submission and checking of homework(review of the previous session), 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 (thoughts on the day is sessions) 5.After each session, subjects will assess the session with an achievement checklist and homework with an achievement checklist, and the BPRS will be administered monthly 6.Once all 20 sessions end, a questionnaire will be distributed to subjects for them to complete (SFS-J,STAI,IRI-J,WHOQOL26,GSES, a survey, and a survey after all of the sessions have ended), and the AQ will be administered
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	20 years-old <=
Age-upper limit	50 years-old >=
Gender	Male and Female
Key inclusion criteria	Individuals diagnosed with a psychiatric disorder other than autism spectrum disorder, such as schizophrenia or conversion disorder An outpatient seen by Psychiatry at Kochi University Hospital A score of 3 or lower on one or more of the 3 items in the Basic skills subscale of the KiSS-18 Age 20-50 No restrictions on the sex of subjects In comparison to a member of the general public, a higher total score on the AQ or a higher score on the Social skills or Communication skills subscales of the AQ Little change in medication one month prior to enrollment Individuals who more than points in GAF
Key exclusion criteria	Individuals diagnosed with an autism spectrum disorder A score of 4 or higher on all of the 3 items in the Basic skills subscale of the KiSS-18 In comparison to a member of the general public, a lower total score on the AQ and a lower score on the Social skills and Communication skills subscales of the AQ Individuals outside the eligible age range Individuals who are likely to be admitted because their condition is not stable Individuals less than 50 points in GAF
Target sample size	40

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	783-8505
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	783-8505
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	2018 Year 07 Month 25 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	0
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	Terminated
Date of protocol fixation	2018 Year 07 Month 25 Day
Date of IRB	2018 Year 08 Month 01 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2022 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 07 Month 25 Day
Last modified on	2022 Year 01 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037748