UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011057 |
|---|---|
| Receipt number | R000012873 |
| Scientific Title | Study of expert treatment and transition support for people with severe mental retardation and severe behavioral disorders. |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2019/03/29 14:37:52 |
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Basic information
Public title
Study of expert treatment and transition support for people with severe mental retardation and severe behavioral disorders.
Acronym
Study of expert treatment and transition support for people with severe mental retardation and severe behavioral disorders.
Scientific Title
Study of expert treatment and transition support for people with severe mental retardation and severe behavioral disorders.
Scientific Title:Acronym
Study of expert treatment and transition support for people with severe mental retardation and severe behavioral disorders.
Region
| Japan |
Condition
Condition
Mental retardation
Autistic spectrum disorder
Severe behavioral disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establish Evidence for making guideline about expert treatment and transition support for people with severe mental retardation and severe behavioral disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
frequency of behavioral disorders
Key secondary outcomes
Criteria for severe behabioral disorders
Aberrant Behavior Checklist-Japanese version(total points and subscale of excitability
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Behavior therapy and Structualization, and Transition support to facilities or home for patients with severe mental retardation and severe behavioral disorders(2-6months)
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Over 20 points of Criteria for severe behavioral disorders
Over 18 points of Aberrant Behavior Checklist-Japanese,subscale of excitability
Key exclusion criteria
Patients with not consent of Guardian of Adult or parents
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Chie |
| Middle name | |
| Last name | Aita |
Organization
National Hospital Organization Hizen Psychiatric Center
Division name
medical office
Zip code
842-0192
Address
160 mitsu yoshinogari saga japan
TEL
0952-52-3231
ai-chie@po.bunbun.ne.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Aita |
Organization
National Hospital Organization Hizen Psychiatric Center
Division name
medical office
Zip code
842-0192
Address
160 mitsu yoshinogari saga japan
TEL
0952-52-3231
Homepage URL
ai-chie@po.bunbun.ne.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Central Ethics Review Committee
Address
2-5-23 Higashigaoka Meguro Tokyo japan
Tel
03-5712-5075
kenkyu2004@nho.hosp.go.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
国立病院機構肥前精神医療センター（佐賀県）、賀茂精神医療センター（広島県）、やまと精神医療センター（奈良県）、花巻病院（岩手県）、岩手病院（岩手県）、さいがた病院（新潟県）、北陸病院（富山県）、富山病院（富山県）、小諸高原病院（長野県）、三重病院（三重県）、鈴鹿病院（三重県）、四国こどもとおとなの医療センター（香川県）、菊池病院（熊本県）、琉球病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | 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
59
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Currently Japanese Journal of Child and Adolescent Psychiatry during final review.
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
| 2013 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 27 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012873
