UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021464
Receipt number R000024756
Scientific Title Exploratory Clinical Trial on Methods and Effects of Tojisha-Kenkyu for Autism Spectrum Disorder
Date of disclosure of the study information 2016/03/20
Last modified on 2016/09/13 21:48:02

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Basic information

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

Condition

Autism Spectrum Disorder

Classification by specialty

Pediatrics Psychiatry Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

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



Assessment

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


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

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

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

Institute

Department

Personal name



Funding Source

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



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2016 Year 03 Month 20 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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name