UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047753 |
|---|---|
| Receipt number | R000054441 |
| Scientific Title | A single-center, randomized, two-arm study to identify effective nursing support from conception through implementation of a "program to increase self-efficacy with regard to parenting for parents" for pregnant couples expecting their first child. |
| Date of disclosure of the study information | 2022/10/31 |
| Last modified on | 2024/05/15 17:56:57 |
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Basic information
Public title
Study for nursing support using a program to increase self-efficacy regarding parental child care for pregnant couples expecting their first child.
Acronym
Study to increase self-efficacy with respect to parenting to parents.
Scientific Title
A single-center, randomized, two-arm study to identify effective nursing support from conception through implementation of a "program to increase self-efficacy with regard to parenting for parents" for pregnant couples expecting their first child.
Scientific Title:Acronym
Study to increase self-efficacy with respect to parenting to parents.
Region
| Japan |
Condition
Condition
Selection criteria include generally uncomplicated pregnant couples expecting their first child, including healthy couples.
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To implement a "program to enhance self-efficacy with regard to child-rearing for parents" (support and evaluation to enhance "child-rearing ability" and promote "development of parental nature") by utilizing the strengths and complementarities of parents from pregnancy to child-rearing period, and to clarify support methods and effectiveness to enhance "self-efficacy with regard to child-rearing" and "self-efficacy as a parent".
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We will evaluate whether "self-efficacy for child-rearing" and "self-efficacy as a parent" have increased through the program from around 20 weeks of pregnancy to one month postpartum. Specifically, we will evaluate both qualitatively and quantitatively (three different scales: self-efficacy, parenting skills, and parental development) how parents perceive "parenting skills" and "parental development".
Key secondary outcomes
Assess parents' "marital archetypes" (defining three archetypes regarding the division of household and childcare roles) and "parents' strengths" (the strengths of both parents as perceived by the parents) that have increased their self-efficacy.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A set of face sheets to know the background of the parents, which will be necessary for the two interventions (interviews), will be given to the parents and they will be asked to answer the questions.
As an intervention during the gestational period, interviews are conducted with parents based on a pre-surveyed face sheet. As preparation for child rearing from the gestational period, questions will be asked in accordance with a program designed to enhance "self-efficacy in child rearing" and "self-efficacy as a parent" that promotes a positive view of child rearing and the development of parenthood ["Program to enhance self-efficacy in child rearing for parents"]. The implementation should be done at about 25 weeks' gestation.
Interventions/Control_2
The intervention during the child-rearing period will focus on practical child-rearing, relating it to the child-rearing preparation that has been ongoing since the pregnancy period, since child-rearing has actually begun. Interviews will be conducted with the parents in accordance with the program ["A Program to Increase Parents' Self-Efficacy in Parenting"].
The implementation of the program will be Aimed at the 2-week postpartum checkup.
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
First-time mothers and their husbands between the ages of 20 and 40 years old who generally have no history of complications or psychiatric disorders who agree to the purpose and conduct of the study. Pregnant women should have a normal pregnancy and be about 20 weeks pregnant. Both spouses must be able to speak, read, and write Japanese and plan to raise their child together after discharge from the hospital.
Key exclusion criteria
Exclusion criteria will include couples with an abnormal pregnancy course, physical or mental disabilities, fetal complications, multiple pregnancies, inability to give consent for this research study, or plans to move to a distant location, making it difficult to conduct interviews.
If an unexpected situation occurs after delivery, and the child has a serious illness or is admitted to the NICU, or if a serious situation arises that delays the mother's postpartum recovery, she will be excluded at that time.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Morita |
Organization
Tokyo Medical and Dental University
Division name
Community Health Promotion Nursing, Graduate School of Health Care Sciences
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8510, Japan
TEL
03-5803-5337
Morita.phn@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Hoki |
Organization
Tokyo Medical and Dental University
Division name
Community Health Promotion Nursing, Graduate School of Health Care Sciences
Zip code
113-8510
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8510, Japan
TEL
03-5803-5337
Homepage URL
ns160009@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Yokohama Foundation for Advancement of Medical Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee of Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8510, 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
| 2022 | Year | 10 | Month | 31 | 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
20
Results
20 pairs of parents were recruited and conducted. There were two dropouts, one from the intervention group and one from the control group.
The study found that there was diversity in attitudes towards self-efficacy itself.
The intervention provided an opportunity for parents to share information, discuss issues and consider strategies to resolve them, which in some cases led to a change in thinking among parents.
Results date posted
| 2024 | Year | 05 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The women are generally first-time mothers and their husbands between the ages of 20 and 40 with no history of complications or mental illness. Pregnant women should have a normal pregnancy, be able to speak, read, and write Japanese, and plan to raise their children together after discharge from the hospital.
Participant flow
Adverse events
not applicable
Outcome measures
These include changes in "self-efficacy for child-rearing" and "parental self-efficacy" between pregnancy and child-rearing. In addition, we will evaluate "parenting skills" and "parental development," which are thought to be related to these self-efficacies.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Knowing self-efficacy with respect to child care from gestational age can predict actual child care implemented during the parenting period.
Management information
Registered date
| 2022 | Year | 05 | Month | 14 | Day |
Last modified on
| 2024 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054441
