UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000050036
Receipt number R000057001
Scientific Title Interview survey
Date of disclosure of the study information 2023/01/14
Last modified on 2023/01/14 10:37:59

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Basic information

Public title

Interview survey on mothers' child-rearing ingenuity according to their own characteristics

Acronym

Interview survey on mothers' child-rearing ingenuity according to their own characteristics

Scientific Title

Interview survey

Scientific Title:Acronym

Interview survey

Region

Japan


Condition

Condition

developmental disorders

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This research clarifies the problems of childcare and housework according to one's own characteristics and how to deal with them.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Characteristics of mothers who care for infants
A story of child-rearing problems and ingenuity according to the mother's characteristics
A narrative of housework troubles and ingenuity according to the mother's characteristics

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

18 years-old <=

Age-upper limit

50 years-old >=

Gender

Female

Key inclusion criteria

First child is under 2 years old
A score of 26 or higher on at least one of the self-characteristic scales

Key exclusion criteria

Excludes people who cannot speak Japanese

Target sample size

18


Research contact person

Name of lead principal investigator

1st name Yuki
Middle name
Last name Kanazawa

Organization

University of Tsukuba

Division name

Faculty of Medicine

Zip code

305-8575

Address

1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan

TEL

029-853-3985

Email

ykanazawa@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name Yuki
Middle name
Last name Kanazawa

Organization

University of Tsukuba

Division name

Faculty of Medicine

Zip code

305-8575

Address

1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan

TEL

029-853-3985

Homepage URL


Email

ykanazawa@md.tsukuba.ac.jp


Sponsor or person

Institute

others

Institute

Department

Personal name



Funding Source

Organization

others

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

The Ethics Committee of the Faculty of Medicine, University of Tsukuba

Address

1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan

Tel

029-853-3022

Email

sien.ningenss@un.tsukuba.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

2023 Year 01 Month 14 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

Open public recruiting

Date of protocol fixation

2022 Year 10 Month 03 Day

Date of IRB

2022 Year 11 Month 25 Day

Anticipated trial start date

2022 Year 12 Month 20 Day

Last follow-up date

2023 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Nursery-related facilities put up posters and distribute leaflets to parents of children under the age of two.
The poster and leaflet included a QR code for the video and questionnaire explaining the contents of this research.
The researcher will contact those who scored 26 points or more in the questionnaire.
Withdrawal of consent is possible within one week after completing the questionnaire and one week after completing the interview survey.


Management information

Registered date

2023 Year 01 Month 14 Day

Last modified on

2023 Year 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057001


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name