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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000043660
Receipt No. R000049669
Scientific Title Relationship between sleep and daytime problems in preschool children and their parents' mental health.
Date of disclosure of the study information 2021/03/18
Last modified on 2021/10/15

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Basic information
Public title Questionnaire on sleep and mood
Acronym Questionnaire on sleep and mood
Scientific Title Relationship between sleep and daytime problems in preschool children and their parents' mental health.
Scientific Title:Acronym Relationship between sleep and daytime problems in preschool children and their parents' mental health.
Region
Japan

Condition
Condition nothing
Classification by specialty
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the relationship between sleep problems and resulting daytime symptoms in preschool children and child behavioral problems that are independent of sleep problems as factors associated with maternal depression.
Basic objectives2 Others
Basic objectives -Others In addition to raising awareness of preschoolers' sleep problems and the importance of early sleep education, the project will revise the content of conventional sleep education and develop more effective sleep education programs for three main areas: children's sleep problems, daytime symptoms, and maternal depression.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sleep Questionnaire-Preschool for Preschooler
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
2 years-old <=
Age-upper limit
7 years-old >=
Gender Male and Female
Key inclusion criteria nothing in particular
Key exclusion criteria nothing in particular
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Naoko
Middle name
Last name Inada
Organization Teikyo University
Division name Faculty of Liberal Arts
Zip code 192-0395
Address 359 Otsuka, Hachioji City, Tokyo
TEL 042-678-3327
Email n-inada@main.teikyo-u.ac.jp

Public contact
Name of contact person
1st name Shun
Middle name
Last name Nakajima
Organization National Center of Neurology and Psychiatry
Division name National Center for Cognitive Behavior Therapy and Research
Zip code 187-8551
Address 4-1-1 Ogawa-higashi-cho, Kodaira-shi, Tokyo
TEL 042-341-2711
Homepage URL
Email child.develop21@gmail.com

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Pfizer Health Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Teikyo University, Committee on Ethics in Psychological Research Involving Human Subjects
Address 359 Otsuka, Hachioji City, Tokyo
Tel 042-678-3603
Email psychirb@main.teikyo-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

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 18 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 Suspended
Date of protocol fixation
2021 Year 02 Month 15 Day
Date of IRB
2021 Year 02 Month 25 Day
Anticipated trial start date
2021 Year 02 Month 25 Day
Last follow-up date
2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Since this was an observational study, the protocol was not made public. As for the feedback of the study, we will report the overall results by e-mail or other means if you wish to do so to the contact information provided in the questionnaire, and we will also distribute to the cooperating preschools a pamphlet that clearly summarizes the findings of the study.

Management information
Registered date
2021 Year 03 Month 18 Day
Last modified on
2021 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049669

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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