UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033678 |
|---|---|
| Receipt number | R000038396 |
| Scientific Title | Development of an intervention program customized to child rearing support groups |
| Date of disclosure of the study information | 2018/08/08 |
| Last modified on | 2022/02/16 10:20:40 |
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Basic information
Public title
Development of an intervention program customized to child rearing support groups
Acronym
Development of an intervention program
Scientific Title
Development of an intervention program customized to child rearing support groups
Scientific Title:Acronym
Development of an intervention program
Region
| Japan |
Condition
Condition
Child rearing support groups
Couples expecting babies
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine issues that support groups face when they provide child rearing services, and develop a child rearing program protocol which can be customized to their needs. This protocol is expected to improve quality of support groups' services.
Basic objectives2
Others
Basic objectives -Others
We evaluate an antenatal couple-based parenting support program
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Implementation reports and group discussion contents of child rearing support group
Key secondary outcomes
Edinburgh Postnatal Depression Scale
Marital-Adjustment Test
Married Couples' Communication Attitudes
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Couples participate in the antenatal Empathy Session for 2 hours, and additional information is mailed a week after the Session and 6 weeks after childbirth.
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
Couples expecting babies
Key exclusion criteria
Women with medical complications and their husbands
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kayoko |
| Middle name | |
| Last name | Ishii |
Organization
Fukushima Medical University
Division name
Radiation Medical Science Center
Zip code
9601295
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1723
kayokoi@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | Ishii |
Organization
Fukushima Medical University
Division name
Radiation Medical Science Center
Zip code
9601295
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1723
Homepage URL
kayokoi@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Fukushima Medical University
Address
1 Hikarigaoka, Fukushima, Japan
Tel
024-547-1723
kayokoi@fmu.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
| 2018 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
This study protocol is not available to the public.
Publication of results
Published
Result
URL related to results and publications
DOI: 10.1080/07399332.2019.1643350
Number of participants that the trial has enrolled
62
Results
We collaborated with five childcare support groups across Japan.
After conducting a training session for the groups' key service providers, we implemented a new childrearing support program targeting expectant couples.
Group meetings were then held to discuss their impressions of the program and areas for improvement. Based on these discussions, we created a manual booklet for the antenatal
childrearing support program.
Results date posted
| 2022 | Year | 02 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Child rearing support groups
Couples expecting babies
Participant flow
In collaboration with five childcare support groups, training sessions were held and programs were provided to a total of 31 pregnant couples.
Adverse events
None
Outcome measures
Edinburgh Postnatal Depression Scale
Marital-Adjustment Test
Married Couples' Communication Attitudes
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 06 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 08 | Day |
Last modified on
| 2022 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038396
