UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006236 |
|---|---|
| Receipt number | R000007372 |
| Scientific Title | Verification of the diagnosis and the psychological intervention for individuals with developmental disorders |
| Date of disclosure of the study information | 2011/08/26 |
| Last modified on | 2014/12/26 12:46:08 |
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Basic information
Public title
Verification of the diagnosis and the psychological intervention for individuals with developmental disorders
Acronym
Verification of the diagnosis and the psychological intervention for individuals with developmental disorders
Scientific Title
Verification of the diagnosis and the psychological intervention for individuals with developmental disorders
Scientific Title:Acronym
Verification of the diagnosis and the psychological intervention for individuals with developmental disorders
Region
| Japan |
Condition
Condition
Autism spectrum disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the psychological intervention for individuals with autism spectrum disorders by structured interview, questionnaire and cognitive function test
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
TAS-20, CISS and ASD questionnaire scores and the percentage of correct response on the MPMR task at post intervention.
Key secondary outcomes
TAS-20, CISS and ASD questionnaire scores and the percentage of correct response on the MPMR task at 12 week follow up and STAI, SPAI, LSAS, CES-D, GAF, WHO QOL 26 scores at the post intervention and 12 week follow up.
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
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive Behavior Therapy
Interventions/Control_2
waitlist
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) ADOS or ADIR with a score above the ASD cut off
2) a full IQ of at least 85 and a verbal IQ of 100 or above (IQ will be evaluated using the WAIS-III)
3) high school graduate or above
4) knowledge of ones diagnosis
5) realization of ones poor emotional self-awareness/ability to express emotion and poor understanding of others emotions and thoughts
6) willingness to participate
Key exclusion criteria
Sever psychiatric complication
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuki Kawakubo |
Organization
University of Tokyo Hospital
Division name
Department of Child Neuropsychiatry
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
0358008664
kawakuboyuki@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miho Kuroda |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Child Neuropsychiatry
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
0358006894
Homepage URL
pr6m-krd@asahi-net.or.jp
Sponsor or person
Institute
Departument of Nueropsychiatry, University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Jpapan
Other related organizations
Co-sponsor
National Center of Neurology and Psychiatry
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
東京大学医学部附属病院（東京都）、国立精神神経医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 26 | Day |
Related information
URL releasing protocol
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3726296/
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 | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 26 | Day |
Last modified on
| 2014 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007372
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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