UMIN-CTR Clinical Trial

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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