UMIN-CTR Clinical Trial

Public title

Exploratory Clinical Trial on Methods and Effects of Tojisha-Kenkyu for Autism Spectrum Disorder

Acronym

TK for ASD study

Scientific Title

Exploratory Clinical Trial on Methods and Effects of Tojisha-Kenkyu for Autism Spectrum Disorder

Scientific Title:Acronym

TK for ASD study

Region

Japan

Condition

Autism Spectrum Disorder

Classification by specialty

Pediatrics	Psychiatry	Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effect of Tojisha-kenkyu program on well-being among adults with high-functioning autism spectrum disorder using interviews, self-administered questionnaire and neuroimaging.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

Sense of Coherence

Key secondary outcomes

Executive Function Tasks
The Japanese Version of the 20-Item Toronto Alexithymia Scale
State-Trait Anxiety Inventory
17-Item Hamilton Rating Scale for Depression
The Japanese Version of Rumination-Reflection Questionnaire
Autobiographical Memory Task
Sentence Completion for Events from the Past Test-Positive and Negative Edition
The Japanese Version of an Advanced Test of Theory of Mind
The Japanese Version of 36-Item Short-Form Health Survey Version 2.0

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

Before and after the program, participants' characteristics are measured by interviews, psychological tasks, questionnaires, experiments and neuroimaging. Parts of results are reported to participants before the program so as to be used as resources for tojisha-kenkyu, with the exception of items which are measured after the program again.
The program consists of 12 sessions conducted weekly and separates into 3 subprograms: Research on Specific Themes (ROST) 6 times, Research on Social Majorities (ROSM) 6 times and Research on the Self (ROTS) 12 times. ROST and ROSM are alternately run every two weeks in the first half of every session for an hour. ROTS is run very week in the second half of every session for an hour.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Diagnosed with Pervasive Developmental Disorders by the DSM-IV-TR or Autism Spectrum Disorder by DSM-5
2)The Diagnosis of ASD is Disclosed
3)Aged over 20 years
4)informed consent obtained in the form of a written document

Key exclusion criteria

5)Full Scale IQ (FSIQ)< 85 or Verbal IQ (VIQ)< 85 by Wechsler Adult Intelligence Scale-III
6)Complicated Mental disorders are unstable
7)Assessed to be inappropriate by doctor-in-charge

Target sample size

16

Name of lead principal investigator

1st name
Middle name
Last name	Shin-ichiro Kumagaya

Organization

The University of Tokyo

Division name

Research Center for Advanced Science and Technology

Zip code

Address

Room 505, Bldg 3, RCAST, 4-6-1, Komaba, Meguro-ku, Tokyo

TEL

03-5452-5063

Email

kumashin@bfp.rcast.u-tokyo.ac.jp

Name of contact person

1st name
Middle name
Last name	Shin-ichiro Kumagaya

Organization

The University of Tokyo

Division name

Research Center for Advanced Science and Technology

Zip code

Address

Room 505, Bldg 3, RCAST, 4-6-1, Komaba, Meguro-ku, Tokyo

TEL

03-5452-5063

Homepage URL

Email

kumashin@bfp.rcast.u-tokyo.ac.jp

Institute

Tojisha-Kenkyu laboratory, Research Center for Advanced Science and Technology, The University of Tokyo

Institute

Department

Personal name

Organization

Grant-in-Aid for Scientific Research on Innovative Areas 'Constructive Developmental Science' [grant number 24119006]

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2016

Year

03

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Date of protocol fixation

2016

Year

03

Month

10

Day

Date of IRB

Anticipated trial start date

2016

Year

03

Month

20

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

03

Month

14

Day

Last modified on

2016

Year

09

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024756