UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043660 |
|---|---|
| Receipt number | 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 | 2023/04/16 20:14:07 |
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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
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
child.develop21@gmail.com
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
https://www.jsdp.jp/jsdp2023/program-pre.html
Publication of results
Partially published
Result
URL related to results and publications
https://www.jsdp.jp/jsdp2023/program-pre.html
Number of participants that the trial has enrolled
232
Results
Path analysis showed a significant positive path from children's emotional/behavioral problems to sleep problems and a significant negative path from children's daytime activity time and parenting behaviors that promote children's sleep to children's sleep problems. There was also a significant positive path from children's emotional/behavioral problems and children's sleep problems to maternal depression.
Results date posted
| 2023 | Year | 04 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The average age of the mothers was 38.4 years (range 24-50). 19.4% were full-time workers, 24.1% were part-time workers, 44.0% were housewives, 4.3% were on parental leave, 6.5% were other workers, and 1.7% were part-time workers. The average age of the children was 61.7 months (range 48-83), 48.7% were girls and 51.3% were boys. Regarding enrollment, 66.4% of the children were enrolled in kindergarten and 31.9% in preschool.
Participant flow
A questionnaire survey was administered to parents of preschool children attending a total of 9 kindergartens and nursery schools. The final analysis sample consisted of 232 pairs of preschool children and their parents.
Adverse events
none
Outcome measures
Japanese Sleep Questionnaire for Preschoolers (JSQ-P), Strengths and Difficulties Questionnaire (SDQ), Maternal depression (Patient Health Questionnaire-9:PHQ-9) , Child-rearing behaviors that promote sleep(Among the ABCs of SLEEPING, six items related to child-rearing behaviors were used from the items indicated as Strong-Moderate in the level of evidence by Allen et al. (2016)), Daytime activity time of the child, Screen time
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049669
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| Registered date | File name |
| Research case data | |
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