UMIN-CTR Clinical Trial

Basic information
Public title	Parenting workshop trial for fathers with infants
Acronym	Fathering workshop trial
Scientific Title	Parenting workshop trial for fathers with infants
Scientific Title:Acronym	Fathering workshop trial
Region	Japan

Condition
Condition	NO
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of our research is to carry out workshop for father with infant and male.
Basic objectives2	Others
Basic objectives -Others	Father-infant bonding Parenting behaviors
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	Father-infant bonding
Key secondary outcomes	Parenting behaviors

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Lecture Discussion
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
Key inclusion criteria	Father with infant Male
Key exclusion criteria	NO
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Aya Middle name Last name Goto
Organization	Fukushima Medical University
Division name	Center for Integrated Science and humanities
Zip code	960-1295
Address	1 Hikarigaoka, Fukushima-City
TEL	024-547-1835
Email	agoto@fmu.ac.jp

Public contact
1st name of contact person	1st name Kazuki Middle name Last name Yoshida
Organization	Fukushima Medical University Graduate School
Division name	International Community Health
Zip code	960-1295
Address	1 Hikarigaoka, Fukushima-City
TEL	024-547-1835
Homepage URL
Email	kazuki-y@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University Graduate School International Community Health
Institute
Department

Funding Source
Organization	Fukushima Gender Equality Center
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Fukushima Medical University
Address	1 Hikarigaoka, Fukushima-City
Tel	024-547-1794
Email	rs@fmu.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	2019 Year 03 Month 17 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	2019 Year 01 Month 16 Day
Date of IRB	2019 Year 01 Month 16 Day
Anticipated trial start date	2019 Year 03 Month 17 Day
Last follow-up date	2021 Year 03 Month 17 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 17 Day
Last modified on	2019 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041278