UMIN-CTR 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
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
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
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/ctr_e/ctr_view.cgi?recptno=R000041551
