UMIN-CTR Clinical Trial

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
Last 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
Email	ai-chie@po.bunbun.ne.jp

Public contact
1st 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
Email	ai-chie@po.bunbun.ne.jp

Sponsor
Institute	National Hospital Organization
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012873