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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000021464
Receipt No. 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

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

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
URL(English) https://upload.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


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