UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049218 |
|---|---|
| Receipt number | R000056056 |
| Scientific Title | A Before-and-After Comparative Study of the Effects of the Home Visiting Parenting Training Program "Safecare" on Caregivers' Parenting Skills |
| Date of disclosure of the study information | 2022/10/15 |
| Last modified on | 2024/02/26 13:58:50 |
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Basic information
Public title
A Before-and-After Comparative Study of the Effects of the Home Visiting Parenting Training Program "Safecare" on Caregivers' Parenting Skills
Acronym
A Before-and-After Comparative Study of SafeCare
Scientific Title
A Before-and-After Comparative Study of the Effects of the Home Visiting Parenting Training Program "Safecare" on Caregivers' Parenting Skills
Scientific Title:Acronym
A Before-and-After Comparative Study of SafeCare
Region
| Japan |
Condition
Condition
Caregiver's parenting skill and parenting environment
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) To examine whether the implementation of the home visiting parenting program improves the parenting behavior of the caregivers.
(2) Examine whether the implementation of the home visiting parenting program improves the child-rearing environment in the home.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
parenting behavior of the caregivers (i.e., positive parent-child interaction skills)
child-rearing environment in the home (i.e., number of hazards in the room)
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Parent training will be provided through home visits. There are two modules, one to increase positive parent-child interaction skills and the other to remove indoor hazards to prevent unintentional injuries, each with approximately six visits. Home visits are conducted once a week for one hour by a trained home visitor.
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 and Female
Key inclusion criteria
Among families whose children have been received out-of-home care in children's homes in Fukuoka City and families who have been identified by the child-rearing support department at city hall as having a large child-rearing burden and needing support for building parent-child relationships (including families who have used administrative services such as respite care), the multidisciplinary professionals will select families for the program at the meeting, and the main caregivers of those families who give their consent will be eligible for the program.
Key exclusion criteria
Families with urgent issues (e.g., families in need of immediate psychiatric treatment due to suicide attempts, families in need of protection due to domestic violence, etc.) and families without a stable living environment (families that need to secure food and clothing first) are not eligible.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yui |
| Middle name | |
| Last name | Yamaoka |
Organization
Tokyo Medical and Dental University
Division name
Department of Global Health Promotion
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
0358035287
yamaoka.hlth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yui |
| Middle name | |
| Last name | Yamaoka |
Organization
Tokyo Medical and Dental University
Division name
Department of Global Health Promotion
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, JAPAN
TEL
0358035287
Homepage URL
yamaoka.hlth@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Department of Global Health Promotion
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University, Faculty of Medicine Ethics Committee
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, JAPAN
Tel
0358035096
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
| 2022 | Year | 10 | 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
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
| 2022 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 10 | Month | 14 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056056
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
