UMIN-CTR Clinical Trial

Basic information
Public title	The Early Partnership Project: evaluation of a new community service
Acronym	Evaluation of the Early Partnership Project
Scientific Title	The Early Partnership Project: evaluation of a new community service
Scientific Title:Acronym	Evaluation of the Early Partnership Project
Region	Japan

Condition
Condition	Pregnant Women
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verify the effectiveness of new services aimed at improving shortcomings of existing child care support services, based on survey data from a cohort of pregnant women.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Maternal perceived capacity in life
Key secondary outcomes	Maternal Service Usage Maternal Service Satisfaction Maternal Attachment Information recorded in the Maternal & Child Healthcare Handbook (Birth weight, Gestational age at birth, maternal difficulty in childcare, etc.) Social Support Maternal mental well-being (WHO5) Maternal depression (EPDS) Maternal self esteem (Rosenberg self esteem scale) Maternal auditory hallucination experiences Maternal attitudes toward childcare

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Eligible women receive regular support from a trained Family Support Workers in the community from the time of conception through the first year postpartum. Family Support Workers will support eligible women from early gregnancy up to 1 year after childbirth. The FSWs will hold multidisciplinary discussion meetings to evaluate lifestyle and psychological state etc., identify unmet needs, and establish action plans for the participating women.
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	16 years-old <=
Age-upper limit	25 years-old >=
Gender	Female
Key inclusion criteria	Pregnant women who will submit their pregnancy notification during the 8-month period from August 2022 to March 2023 (with the possibility of extension), who are first-time pregnant women between the ages of 16 and 25 and who are able to answer the questionnaire in Japanese.
Key exclusion criteria	If an eligible pregnant woman is identified, but already has plans to move out of the municipality permanently, she will not be recruited to the program. However, if the move is temporary (for example, in the case of returning to her hometown to give birth), she will be recruited.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kaori Middle name Last name Baba
Organization	Tokyo Metropolitan Institute of Medical Science Research Center
Division name	Research Center for Social Science & Medicine Unit for Mental Health Promotion
Zip code	1568506
Address	2-1-6 Kamikitazawa, Setagayaku, Tokyo
TEL	+81-3-6834-2293
Email	baba-kr@igakuken.or.jp

Public contact
Name of contact person	1st name Kaori Middle name Last name Baba
Organization	Tokyo Metropolitan Institute of Medical Science
Division name	Research Center for Social Science & Medicine Unit for Mental Health Promotion
Zip code	1568506
Address	2-1-6 Kamikitazawa, Setagayaku, Tokyo
TEL	+81-3-6834-2293
Homepage URL
Email	baba-kr@igakuken.or.jp

Sponsor
Institute	Tokyo Metropolitan Institute of Medical Science Research Center
Institute
Department

Funding Source
Organization	Commissioned by Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Center for Medical Research Cooperation, Tokyo Metropolitan Institute of Medical Science
Address	2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
Tel	+81-3-6834-2391
Email	renkei@igakuken.or.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	2022 Year 08 Month 01 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	Preinitiation
Date of protocol fixation	2022 Year 07 Month 01 Day
Date of IRB	2022 Year 07 Month 21 Day
Anticipated trial start date	2022 Year 08 Month 01 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	2022 Year 07 Month 30 Day
Last modified on	2022 Year 07 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055115

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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