UMIN-CTR Clinical Trial

Basic information
Public title	Regional childcare support based on infant mental health Educate and establish parent mentors through collaboration between specialized IMH nurses and parent mentaors
Acronym	Regional childcare support based on infant mental health
Scientific Title	Regional childcare support based on infant mental health
Scientific Title:Acronym	Regional childcare support based on infant mental health
Region	Japan

Condition
Condition	Parent of child with developmental disabilities
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Build a foundation for regional child care support through to train parent mentor who parents of child with developmental disorder
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate parent-child relationships before and after training
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom Maneuver
Interventions/Control_1	Trained Parent Mentor (intervention group) Training period 2 years Training contents: Lecture and practice
Interventions/Control_2	Parents who do not training (control group)
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	30 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	mothers of child with developmental disorder
Key exclusion criteria	father of child with developmental disorder
Target sample size	3

Research contact person
Last name of lead principal investigator	1st name Keiko Middle name Last name Komoto
Organization	Okawa children and family clinic
Division name	Infant mental health child care support
Zip code	146-0095
Address	1-6-16, Tamagawa, Ota-ku, Tokyo, Japan
TEL	03-3758-0920
Email	kkomoto@ocfc.jp

Public contact
1st name of contact person	1st name Keiko Middle name Last name Komoto
Organization	Okawa children and family clinic
Division name	Infant mental health child care support
Zip code	146-0095
Address	1-6-16, Tamagawa, Ota-ku, Tokyo, Japan
TEL	03-3758-0920
Homepage URL
Email	kkomoto@ocfc.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	MEXT(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel	03-5803-5096
Email	syomu1.adm@tmd.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 04 Month 10 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	2019 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2019 Year 06 Month 01 Day
Last follow-up date	2021 Year 10 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	2019 Year 04 Month 10 Day
Last modified on	2019 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041551