UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054313 |
|---|---|
| Receipt number | R000062007 |
| Scientific Title | Development of a training program to improve skills in supporting parent-child relationships in comprehensive support for child-rearing households |
| Date of disclosure of the study information | 2024/07/15 |
| Last modified on | 2025/11/06 09:28:40 |
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Basic information
Public title
Development of a training program to improve skills in supporting parent-child relationships in comprehensive support for child-rearing households
Acronym
Development of a training program to improve parent-child relationship support skills
Scientific Title
Development of a training program to improve skills in supporting parent-child relationships in comprehensive support for child-rearing households
Scientific Title:Acronym
Development of a training program to improve parent-child relationship support skills
Region
| Japan |
Condition
Condition
non-handicapped person
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a step-by-step training program for supporters engaged in comprehensive support for child-rearing families nationwide to deepen their knowledge of how to support parent-child relationships based on infant mental health and parent-child interaction theory, and to acquire skills in observation, assessment, and support of parent-child interactions. In addition, we will develop a training program that utilizes ICT. The project will explore training methods that can be implemented in all regions of the country through ICT-based training, and develop a sustainable platform.
Basic objectives2
Others
Basic objectives -Others
Prospective longitudinal association exploratory study, Implementation and evaluation of the "Parent-child relationship support skills training" program
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of the "Parent-child relationship support skills training" after taking the course
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The "Parent-Child Relationship Support Skills Training" will be delivered through a dedicated web page.
The training is a four-step program, with the first four steps in sequence, from infant mental health and NCAST concepts to professional practice applications.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Supporters who provide support at facilities that provide user support in comprehensive support for child-rearing, and at health centers operated by municipalities that provide maternal and child health support. A person registered as a supporter
Key exclusion criteria
1.Those who have refused to participate in the research
2.Those who are deemed inappropriate as subjects by the researcher.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Michie |
| Middle name | |
| Last name | Nagayoshi |
Organization
The Jikei University
Division name
School of Nursing
Zip code
182-8570
Address
8-3-1, Kokuryo-cho, Chofu-shi, Tokyo
TEL
0334801151
mnaga1@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Michie |
| Middle name | |
| Last name | Nagayoshi |
Organization
The Jikei University
Division name
School of nursing
Zip code
182-8570
Address
8-3-1, Kokuryo-cho, Chofu-shi, Tokyo
TEL
0334801151
Homepage URL
https://plaza.umin.ac.jp/~imh/
mnaga1@jikei.ac.jp
Sponsor or person
Institute
The Jikei University
Institute
Department
Personal name
Funding Source
Organization
MEXT KAKENHI 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)
IRB Contact (For public release)
Organization
The Jikei University
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
Tel
0570-053333
rinri@jikei.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
| 2024 | Year | 07 | Month | 15 | 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
| Delay expected |
Results Delay Reason
To obtain responses for the post-training survey, we are currently applying for an extension of the survey period.
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
| 2024 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2024 | Year | 05 | Month | 02 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062007
