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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025717
Receipt No. 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 2019/01/19

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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
Middle name
Last name Mohri Ikuko
Organization Faculty of Medicine, Osaka University.
Division name Pediatrics
Zip code
Address 2-2, Yamadaoka, Suita, Osaka, Japan. Molecular Research Center for Children's Mental Development, Osaka University.
TEL 06-6879-3863
Email ikuko@kokoro.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshizaki Arika
Organization Osaka University
Division name Molecular Research Center for Children's Mental Development, Osaka University
Zip code
Address 2-2, Yamadaoka, Suita, Osaka, Japan. Molecular Research Center for Children's Mental Development
TEL 06-6879-3663
Homepage URL
Email arika@kokoro.med.osaka-u.ac.jp

Sponsor
Institute Faculty of Medicine, Osaka University.
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2017 Year 02 Month 10 Day
Last follow-up date
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
2019 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027308

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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