UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048165 |
|---|---|
| Receipt number | R000054887 |
| Scientific Title | Development of a specialized program for assistance and intervention for persons with challenging behavior during hospitalization Research that contributes to regional transition. |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2022/06/25 12:57:02 |
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Basic information
Public title
Development of a specialized program for assistance and intervention for persons with challenging behavior during hospitalization Research that contributes to regional transition.
Acronym
Development of a specialized program for assistance and intervention for persons with challenging behavior during hospitalization Research that contributes to regional transition.
Scientific Title
Development of a specialized program for assistance and intervention for persons with challenging behavior during hospitalization Research that contributes to regional transition.
Scientific Title:Acronym
Development of a specialized program for assistance and intervention for persons with challenging behavior during hospitalization Research that contributes to regional transition.
Region
| Japan |
Condition
Condition
challenging behavior
intellectual disability
Autism Spectrum Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) Development of specialized treatment and training programs for persons with challenging behavior during hospitalization and evaluation of effects by intervention (year 1-2); 2) Creation of collaboration guidelines for regional transition (year 1-2); and 3) Survey of the future promotion of professional medical care (year 2)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Aberrant Behavior Checklist-Japanese version
(3 weeks or 12 weeks later)
Key secondary outcomes
Behavior Problem Inventory-Short Form
frequency of challenging behavior(3 weeks or 12 weeks later).
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 | Other |
Interventions/Control_1
Behavioral therapies(applied behavior analysis) and structuring based on the TEACCH autism program for challenging behavior.
(3 or 12 weeks)
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
Walkable
10 or more "action-related items" of the disability support classification certification survey
"Strength Behavioral Discrepancy Criteria" 10 points or more
ABC-J more than 18 Irritability sub-scales
Less than IQ70
Key exclusion criteria
Patients who were not agreed by the adult guardian or guardian
A patient whose researchers determine is not appropriate for intervention
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Chie |
| Middle name | |
| Last name | Aita |
Organization
National Hospital Organization Hizen Psychiatric Medical Center
Division name
medical Office
Zip code
842-1292
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 Medical Center
Division name
medical Office
Zip code
842-0192
Address
160 mitsu yoshinogari Saga Japan
TEL
0952523231
Homepage URL
ai-chie@po.bunbun.ne.jp
Sponsor or person
Institute
Ministry of Health, Labour and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Hizen Psychiatric Medical Center
Address
160 mitsu yoshinogari Saga Japan
Tel
0952523231
etou.chika.hr@mail.hosp.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
22GC1019
Org. issuing International ID_1
Ministry of Health, Labour and Welfare
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）、愛知県医療療育総合センター中央病院(愛知県）、岡山県精神科医療センター(岡山県）、国立病院機構菊池病院(熊本県）、千曲荘病院(長野県）、東京都立松沢病院(東京都）、国立病院機構榊原病院(三重県）、洛南病院(京都府）、国立病院機構やまと精神医療センター(奈良県）、松ヶ丘病院(島根県）、国立病院機構賀茂精神医療センター(広島県）
Other administrative information
Date of disclosure of the study information
| 2022 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 25 | Day |
Last modified on
| 2022 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054887
| 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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| Registered date | File name |
