UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049742 |
|---|---|
| Receipt number | R000056622 |
| Scientific Title | Development and Validation of Mental Health Programs for Pre-Moms and Dads in Parents' Classes During Pregnancy |
| Date of disclosure of the study information | 2022/12/10 |
| Last modified on | 2022/12/25 00:08:42 |
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Basic information
Public title
Effectiveness of an educational intervention for postpartum depression in a pre-parent classroom: A non-randomized controlled trial
Acronym
Effectiveness of an educational intervention for postpartum depression in a pre-parent classroom: A non-randomized controlled trial
Scientific Title
Development and Validation of Mental Health Programs for Pre-Moms and Dads in Parents' Classes During Pregnancy
Scientific Title:Acronym
Development and Validation of Mental Health Programs for Pre-Moms and Dads in Parents' Classes During Pregnancy
Region
| Japan |
Condition
Condition
pregnant woman
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to verify the effectiveness of educational interventions focusing on the provision of information for the prevention and early detection of postpartum depression for primiparas and their husbands who participated in the "First Parenthood Class."
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The Edinburgh Postnatal Depression Scale (EPDS)
Key secondary outcomes
Child-rearing difficulty
Recognition of Postpartum Depression and Information Sources
Coping Strategies and Information Helpfulness When Mothers Show Depressive Symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
"First parent class" and one-time explanation held during pregnancy
12-minute explanation with 7 slides
Interventions/Control_2
Distribution of "Mental Health for Future Parents" booklet
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
| 44 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were couples who consented to the study, could understand Japanese, and had a single pregnancy
Key exclusion criteria
Pregnant women with mental illness were excluded
Target sample size
426
Research contact person
Name of lead principal investigator
| 1st name | hisayo |
| Middle name | |
| Last name | Okayama |
Organization
University of Tsukuba
Division name
School of Medicine and Medical Sciences
Zip code
305-8575
Address
1-1-1Tennodai,Tsukuba,Ibaraki
TEL
0298538372
okayama@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Taeko |
| Middle name | |
| Last name | Unno |
Organization
Kyoto Koka Women's University
Division name
Midwifery
Zip code
6150822
Address
38 Nishikyogoku Kadono-cho, Ukyo-ku, Kyoto
TEL
0753662667
Homepage URL
taekomw@mail.koka.acjp
Sponsor or person
Institute
School of Medicine and Medical Sciences, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
N/A
Address
N/A
Tel
N/A
N/A
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 | 12 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jspog/21/3/21_278/_pdf/-char/ja
Publication of results
Unpublished
Result
URL related to results and publications
Preparing for paper submission
Number of participants that the trial has enrolled
158
Results
No significant difference was found between mothers' depression score rates in the first month after childbirth.
Results date posted
| 2022 | Year | 12 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The age of the pregnant women was around 32 years old. The family structure was 4% three-generation family, and the caesarean section rate was 10-20%.
The demographics of our study participants were representative of Japanese women.
Participant flow
There were 158 couples (control group = 86, intervention group = 72) with a valid response rate of 27.8%.
Adverse events
there is no
Outcome measures
1The Edinburgh Postnatal Depression Scale (EPDS)
2Japan Child and Family Research Institute (JCFRI) Child-rearing Support Questionnaire
3The JCFRI Child-rearing Support Questionnaire for Fathers
4Recognition of Postpartum Depression and Information Sources
5Coping Strategies and Information Helpfulness When Mothers Show Depressive Symptoms
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 08 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 03 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 10 | Day |
Last modified on
| 2022 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056622
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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