UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002584 |
|---|---|
| Receipt number | R000003154 |
| Scientific Title | Verification of the diagnosis and the psychosocial intervention for individuals with developmental disorders |
| Date of disclosure of the study information | 2009/10/05 |
| Last modified on | 2014/10/10 15:48:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Verification of the diagnosis and the psychosocial intervention for individuals with developmental disorders
Acronym
Verification of the diagnosis and the psychosocial intervention for individuals with developmental disorders
Scientific Title
Verification of the diagnosis and the psychosocial intervention for individuals with developmental disorders
Scientific Title:Acronym
Verification of the diagnosis and the psychosocial intervention for individuals with developmental disorders
Region
| Japan |
Condition
Condition
developmental disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the psychosocial intervention for individuals with developmental disorders and their families 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
psychiatric symptom after three months
Key secondary outcomes
social and cognitive function after three months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
social skills training
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
IQ > 80
Key exclusion criteria
conduct disorder
Target sample size
20
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 Childpsychiatry
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03(3815)5411
yukik-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Kawakubo |
Organization
University of Tokyo Hospital
Division name
Department of Childpsychiatry
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03(3815)5411
Homepage URL
yukik-tky@umin.ac.jp
Sponsor or person
Institute
Department of Childpsychiatry, University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Pfizer health research foundation
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
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）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 05 | 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
| 2009 | Year | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 05 | Day |
Last modified on
| 2014 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003154
