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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033678
Receipt No. R000038396
Official scientific title of the study Development of an intervention program customized to child rearing support groups
Date of disclosure of the study information 2018/08/08
Last modified on 2018/08/08

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Basic information
Official scientific title of the study Development of an intervention program customized to child rearing support groups
Title of the study (Brief title) Development of an intervention program
Region
Japan

Condition
Condition Child rearing support groups
Couples expecting babies
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine issues that support groups face when they provide child rearing services, and develop a child rearing program protocol which can be customized to their needs. This protocol is expected to improve quality of support groups' services.
Basic objectives2 Others
Basic objectives -Others We evaluate an antenatal couple-based parenting support program
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Implementation reports and group discussion contents of child rearing support group
Key secondary outcomes Edinburgh Postnatal Depression Scale
Marital-Adjustment Test
Married Couples' Communication Attitudes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Couples participate in the antenatal Empathy Session for 2 hours, and additional information is mailed a week after the Session and 6 weeks after childbirth.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Couples expecting babies
Key exclusion criteria Women with medical complications and their husbands
Target sample size 20

Research contact person
Name of lead principal investigator Kayoko Ishii
Organization Fukushima Medical University
Division name Radiation Medical Science Center
Address 1 Hikarigaoka, Fukushima, Japan
TEL 024-547-1723
Email kayokoi@fmu.ac.jp

Public contact
Name of contact person Kayoko Ishii
Organization Fukushima Medical University
Division name Radiation Medical Science Center
Address 1 Hikarigaoka, Fukushima, Japan
TEL 024-547-1723
Homepage URL
Email kayokoi@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

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
2018 Year 08 Month 08 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 22 Day
Anticipated trial start date
2018 Year 06 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 08 Day
Last modified on
2018 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038396

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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