UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Practical Study on the cognitive remediation therapy for the Autism Spectrum Disorder
Title of the study (Brief title)	Cognitive remediation therapy for Autism Spectrum Disorder
Region	Japan

Condition
Condition	Autism Spectrum Disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objectives are to examine whether intervention using the Frontal/Executive Program-Japanese version as one type of CRT could improve cognitive function, social function, and psychiatric symptoms in patients with Autism Spectrum Disorder.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitive function, social function and psychiatric symptoms assessment
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Participants in the intervention group are given 44 sessions of one-on-one FEP twice a week that lasted approximately one hour each.
Interventions/Control_2	The control group receives the usual occupational therapy, such as light work and exercise.
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Inclusion criteria were age of 65 years or less, at least nine years of education, and Autism Spectrum Disorder meeting DSM-5 diagnosis criteria.
Key exclusion criteria	The exclusion criteria were dementia, drug addiction, alcoholism, organic brain disease, pregnancy, an IQ of <50, schizophrenia, and absence of a signed informed consent form.
Target sample size	80

Research contact person
Name of lead principal investigator	Kenzo Denda
Organization	Faculty of Health Science, Hokkaido University
Division name	Department of Functioning and Disability
Address	Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL	+81-11-706-3387
Email	kdenda@med.hokudai.ac.jp

Public contact
Name of contact person	Kenzo Denda
Organization	Faculty of Health Science, Hokkaido University
Division name	Department of Functioning and Disability
Address	Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL	+81-11-706-3387
Homepage URL
Email	kdenda@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University
Institute
Department

Funding Source
Organization	Ministry of Education, Culyure, Sports, Science and technology
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 08 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 05 Month 28 Day
Anticipated trial start date	2016 Year 08 Month 01 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 05 Month 28 Day
Last modified on	2018 Year 01 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025944