UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022508 |
|---|---|
| Receipt number | R000025944 |
| Scientific Title | A Practical Study on the cognitive remediation therapy for the Autism Spectrum Disorder |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2018/01/11 14:10:18 |
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Basic information
Public title
A Practical Study on the cognitive remediation therapy for the Autism Spectrum Disorder
Acronym
Cognitive remediation therapy for Autism Spectrum Disorder
Scientific Title
A Practical Study on the cognitive remediation therapy for the Autism Spectrum Disorder
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Kenzo Denda |
Organization
Faculty of Health Science, Hokkaido University
Division name
Department of Functioning and Disability
Zip code
Address
Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL
+81-11-706-3387
kdenda@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenzo Denda |
Organization
Faculty of Health Science, Hokkaido University
Division name
Department of Functioning and Disability
Zip code
Address
Kita 12, Nishi 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL
+81-11-706-3387
Homepage URL
kdenda@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Terminated
Date of protocol fixation
| 2016 | Year | 05 | Month | 28 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025944
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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