UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033512 |
|---|---|
| Receipt number | R000037748 |
| Scientific Title | Effect to other mental diseases in the autism spectrum disorder communication program |
| Date of disclosure of the study information | 2018/07/25 |
| Last modified on | 2022/01/26 11:07:02 |
* 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
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
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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037748
