UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006367 |
|---|---|
| Receipt number | R000007517 |
| Scientific Title | Standardization of CREIS-Japanese-8 |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2013/04/01 09:46:44 |
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Basic information
Public title
Standardization of CREIS-Japanese-8
Acronym
CREIS-Japanese-8 standardization
Scientific Title
Standardization of CREIS-Japanese-8
Scientific Title:Acronym
CREIS-Japanese-8 standardization
Region
| Japan |
Condition
Condition
Post traumatic stress disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the treatment and support for the children with PTSD symptoms, a simple measure is needed to select the subjects or to verify the effectiveness. The purpose of this study is to examine the reliability and validity of CREIS-Japanese-8, and to calculate the cut-off point.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) reliability
Internal consistency and test-retest reliability
(2) Validity
Criterion-related validity (coexist validity) and classification validity
(3) cut-off point
Cut-off point is calculated from the sensitivity, specificity, positive predictive value and negative predictive value
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Teaching Recovery Techniques (TRT)
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
| 8 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children affected in the earthquake in Sendai City and its suburbs or visited the Shinshu University Hospital or research partner organizations
Key exclusion criteria
Children can not be obtained informed consent from either themselves or their parents
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuzuru Harada |
Organization
Shinshu University Hospital
Division name
Mental Health Clinic for Children
Zip code
Address
3-1-1 Asahi Matumoto Nagano
TEL
0263-37-3060
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Aonuma |
Organization
Shinshu University Hospital
Division name
Mental Health Clinic for Children
Zip code
Address
3-1-1 Asahi Matumoto Nagano
TEL
0263-37-3060
Homepage URL
Sponsor or person
Institute
Shinshu University Hospital Mental Health Clinic for Children
Institute
Department
Personal name
Funding Source
Organization
Shinshu University Hospital
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 17 | Day |
Last modified on
| 2013 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007517
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
