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UMIN-CTR Clinical Trial |
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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 | 2020/03/03 |
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 |
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Condition | ||
Condition | high functioning Autism Spectrum Disorder | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 72 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
yasumatsuda319@hotmail.com |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Anticipated trial start date |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |