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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023848
Receipt No. R000025669
Scientific Title Effectiveness of a cognitive remediation program with original computerized cognitive training and group intervention for high functioning Autism Spectrum Disorder
Date of disclosure of the study information 2016/10/01
Last modified on 2019/06/20

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Basic information
Public title Effectiveness of a cognitive remediation program with original computerized cognitive training and group intervention for high functioning Autism Spectrum Disorder
Acronym Effectiveness of a cognitive remediation program with original computerized cognitive training and group intervention for high functioning Autism Spectrum Disorder
Scientific Title Effectiveness of a cognitive remediation program with original computerized cognitive training and group intervention for high functioning Autism Spectrum Disorder
Scientific Title:Acronym Effectiveness of a cognitive remediation program with original computerized cognitive training and group intervention for high functioning Autism Spectrum Disorder
Region
Japan

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

Objectives
Narrative objectives1 We aim to examine whether a cognitive remediation program including both computerised cognitive training using Jcores and therapist intervention for transferring gained cognitive improvement into a real-world setting is more effective than treatment as usual.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the Brief Assessment of Cognition in Schizophrenia
Key secondary outcomes Wisconsin Card Soring Test
autism diagnostic observation schedule 2
Life Assessment Scale for Mentally
Social Responsiveness Scale
Conners' Adult ADHD Rating Scales
Impact of Event Scale Revised
intrinsic motivation inventory-Japanese version
Iowa Gambling Task
near infrared spectroscopy
MRI
electroencephalogram
Serum or Plasma protein level

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 a cognitive remediation programme with original computerised cognitive training and group meeting
Interventions/Control_2 Participants engaged in two computerised cognitive training sessions and one group meeting per week for 12 weeks.
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
13 years-old <=
Age-upper limit
40 years-old >
Gender Male and Female
Key inclusion criteria Participants were outpatients diagnosed with autism Spectrum Disorder by psychiatrists according to DSM-5 criteria.
Key exclusion criteria mental retardation
history of drug or alcohol abuse
organic central nervous system disorder
Target sample size 72

Research contact person
Name of lead principal investigator
1st name Yasuhiro
Middle name
Last name Matsuda
Organization Nara Medical University School of Medicine
Division name Department of Psychiatry
Zip code 6348522
Address 840 Shijo-cho, Kashihara, Nara 634-8523, Japan
TEL 0744-22-3051
Email yasumatsuda319@hotmail.com

Public contact
Name of contact person
1st name Yasuhiro
Middle name
Last name Matsuda
Organization Nara Medical University School of Medicine
Division name Department of Psychiatry
Zip code 6348522
Address 840 Shijo-cho, Kashihara, Nara 634-8523, Japan
TEL 0744-22-3051
Homepage URL
Email yasumatsuda319@hotmail.com

Sponsor
Institute Nara Medical University School of Medicine
Institute
Department

Funding Source
Organization KAKENHI
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nara Medical University School of Medicine
Address 840 Shijo-cho, Kashihara, Nara 634-8523, Japan
Tel 0744-22-3051
Email smuraka@naramed-u.ac.jp

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 奈良県立医科大学附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 10 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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 30 Day
Date of IRB
2016 Year 06 Month 21 Day
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 30 Day
Last modified on
2019 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025669

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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