UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006237 |
|---|---|
| Receipt number | R000007379 |
| Scientific Title | Verification of the effect of cognitive rehabilitation program for adults with autism spectrum disorders |
| Date of disclosure of the study information | 2011/08/26 |
| Last modified on | 2015/09/26 09:32:12 |
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Basic information
Public title
Verification of the effect of cognitive rehabilitation program for adults with autism spectrum disorders
Acronym
Verification of the effect of cognitive rehabilitation program for adults with autism spectrum disorders
Scientific Title
Verification of the effect of cognitive rehabilitation program for adults with autism spectrum disorders
Scientific Title:Acronym
Verification of the effect of cognitive rehabilitation program for adults with autism spectrum disorders
Region
| Japan |
Condition
Condition
Autism spectrum disorders (ASD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the small group with CBT intervention for adults with ASD by structured interview, questionnaire and cognitive function test
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Capacity of emotion understanding and regulation skills immediately and three months, 1year,1 and half year and 2years after intervention
Key secondary outcomes
Psychiatric symptom and adaptive behavior immediately and three months, 1year,1 and half year and 2years after intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive Behavior Therapy
Interventions/Control_2
Psychotherapy
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients diagnosed with autistic disorder, Asperger's disorder, or PDD-NOS, based on DSM-IV-TR using Autism Diagnostic Observation Schedule or Autism Diagnostic Interview-Revised
2) Patients with normal intelligence (Verbal IQ is over almost100 and Full IQ is 0ver85 measured with Wechsler Adult Intelligent Scale Third Edition)
3)Schooling History: High school graduate or university degree
Key exclusion criteria
Sever psychiatric comorbidity
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miho Kuroda |
Organization
Syukutoku University
Division name
Department of Psychology
Zip code
Address
200 Daigenjicyo, Cyuoku, Chibashi, 260-871Japan
TEL
043-265-9878
pr6m-krd@asahi-net.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miho Kuroda |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Children and Adolescence mental Health, NIMH
Zip code
Address
4-1-1 Ogawahigashi, Kodairashi, Tokyo
TEL
042-341-2711
Homepage URL
pr6m-krd@asahi-net.or.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 08 | Month | 26 | 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
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 26 | Day |
Last modified on
| 2015 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007379
| 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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