UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025717 |
|---|---|
| Receipt number | R000027308 |
| Scientific Title | The development of Japanese version of "Short Version of the Dysfunctional Beliefs about Sleep Questionnaire for use with Children" (DBAS-C10).[with intervention] |
| Date of disclosure of the study information | 2017/01/19 |
| Last modified on | 2022/08/30 15:49:23 |
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Basic information
Public title
The development of Japanese version of "Short Version of the Dysfunctional Beliefs about Sleep Questionnaire for use with Children" (DBAS-C10).[with intervention]
Acronym
The development of Japanese version of "Dysfunctional Beliefs about Sleep Questionnaire for use with Children" (DBAS-C10).[with intervention]
Scientific Title
The development of Japanese version of "Short Version of the Dysfunctional Beliefs about Sleep Questionnaire for use with Children" (DBAS-C10).[with intervention]
Scientific Title:Acronym
The development of Japanese version of "Dysfunctional Beliefs about Sleep Questionnaire for use with Children" (DBAS-C10).[with intervention]
Region
| Japan |
Condition
Condition
Sleep-related disorders in children
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop the Japanese version of Dysfunctional beliefs about sleep in children questionnaire(DBAS-C10J). The subject of this study are children in glade 5/6 in elementary school and junior high school students in Japan.
For the clinical sample, children's beliefs about sleep will be assessed with DBAS-C10J.
For the healthy sample, psychologists provide sleep health education for healthy children and investigate the cognitive change between pre- and post- education with this questionnaire.
Confirm the reliability and validity of the DBAS-C10J and the effect by psycho-educational intervention about sleep.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 month after first survey.
Short version of Dysfunctional Beliefs and Attitude questionnaire about Sleep in Children. (DBAS-C10J) 10 items
Key secondary outcomes
Children's subjective sleep problems. 3 items
Japanese version of the Pediatric Daytime Sleepiness Scale.(PDSS-J) 8 items
Japanese Sleep Questionnaire for Elementary Schoolers. (JSQ-ES) 38 items
Japanese Sleep Questionnaire for Junior High School Students. (JSQ-JH) 39 items
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group:
Psychologists provide sleep health education program for children at school.(45 minutes, 2 times)
Interventions/Control_2
Control group:
No sleep education program.(attending regular classes)
Interventions/Control_3
Clinical group:
Questionnaire for the children with sleep-related disorders at outpatient sleep clinic.
(No intervention)
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
| 10 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Glade 5 and 6.
Junior high school students.
Study at regular class.
Key exclusion criteria
Serious cognitive impairment (difficult to understand information about research).
Target sample size
430
Research contact person
Name of lead principal investigator
| 1st name | Ikuko |
| Middle name | |
| Last name | Mohri |
Organization
Faculty of Medicine, Osaka University.
Division name
Pediatrics
Zip code
5650871
Address
2-2, Yamadaoka, Suita, Osaka, Japan. Molecular Research Center for Children's Mental Development, Osaka University.
TEL
06-6879-3863
ikuko@kokoro.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Arika |
| Middle name | |
| Last name | Yoshizaki |
Organization
Osaka University
Division name
Molecular Research Center for Children's Mental Development, Osaka University
Zip code
5650871
Address
2-2, Yamadaoka, Suita, Osaka, Japan. Molecular Research Center for Children's Mental Development
TEL
06-6879-3663
Homepage URL
arika@kokoro.med.osaka-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Osaka University.
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Osaka University Clinical Research Review Committee
Address
4th floor, The center of medical innovation and translational research, 2-2, Yamadaoka, Suita, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.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
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 19 | 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
| 2017 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 17 | Day |
Last modified on
| 2022 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027308
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