UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory Clinical Trial on Methods and Effects of Tojisha-Kenkyu for Autism Spectrum Disorder
Title of the study (Brief title)	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	Shin-ichiro Kumagaya
Organization	The University of Tokyo
Division name	Research Center for Advanced Science and Technology
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	Shin-ichiro Kumagaya
Organization	The University of Tokyo
Division name	Research Center for Advanced Science and Technology
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 03 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000024756