UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000036463
Receipt number R000041551
Scientific Title Regional childcare support based on infant mental health
Date of disclosure of the study information 2019/04/10
Last modified on 2019/04/10 12:15:03

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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

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

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 or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041551


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name