UMIN-CTR Clinical Trial

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

psychiatric disorder except autistic spectrum disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

kochi medical school

Institute

Department

Personal name

Organization

no

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

07

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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