UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062245 |
|---|---|
| Receipt number | R000067050 |
| Scientific Title | Development and effects of an intervention programme co-parenting and prevent postpartum depression: A randomised controlled trial |
| Date of disclosure of the study information | 2026/07/22 |
| Last modified on | 2026/07/22 18:21:07 |
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Basic information
Public title
Development and effects of an intervention programme co-parenting and prevent postpartum depression: A randomised controlled trial
Acronym
Development and effects of an intervention programme co-parenting: RCT
Scientific Title
Development and effects of an intervention programme co-parenting and prevent postpartum depression: A randomised controlled trial
Scientific Title:Acronym
Development and effects of an intervention programme co-parenting: RCT
Region
| Japan |
Condition
Condition
Postpartum depression
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to promote co-parenting among expectant mothers and fathers by promoting communication in child-rearing and to examine the effects of this intervention program, including its impact on mental health.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Marital Satisfaction Scale
2. Edinburgh Postnatal Depression Scale
3. Parental Burnout Assessment
4. Amount of time spent communicating together
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Pregnancy Based Coparenting Promotion Program Participants received the Pregnancy Based Coparenting Promotion Program in addition to usual antenatal care. The program consisted of an educational booklet for expectant fathers and mothers, providing information on postpartum maternal physical and psychological changes, infant care, communication between partners, and sharing of parenting and household responsibilities. Participants were encouraged to use the booklet together during pregnancy.
Interventions/Control_2
Participants received routine antenatal care provided by the study institutions.No additional coparenting educational program or study specific intervention was provided.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study was conducted at a general hospital with consent to participate, targeting pregnant women aged 20 or older who were planning to give birth and their husbands. As the study required respondents to answer questionnaires and communicate with midwives, participants were limited to those who could communicate in Japanese.
Key exclusion criteria
Minors and those requiring a proxy were excluded.
Target sample size
112
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Kido |
Organization
Tokushima University
Division name
Department of Midwifery, Graduate School of Biomedical Sciences
Zip code
770-8503
Address
3-18-15,Kuramoto-cho,Tokushima city
TEL
088-633-9080
kido-k@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Kido |
Organization
Tokushima University
Division name
Department of Midwifery, Graduate School of Biomedical Sciences
Zip code
770-8503
Address
3-18-15,Kuramoto-cho,Tokushima city
TEL
088-633-9080
Homepage URL
kido-k@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Kagawa Prefectural University of Health Sciences
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Yashima General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kagawa Prefectural University of Health Sciences
Address
281-1 Hara, Mure-cho, Takamatsu, Kagawa 761-0123, Japan
Tel
087-870-1212
uemura@kagawa-puhs.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
| 2026 | Year | 07 | Month | 22 | 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
112
Results
Baseline characteristics were comparable between the intervention and control groups. Participants generally had high marital satisfaction and low parental burnout and depressive symptoms. A significant group-by-time interaction was observed only for maternal parental burnout. No significant intervention effects were found for maternal depressive symptoms, marital satisfaction, communication time, or any paternal outcomes.
Results date posted
| 2026 | Year | 07 | Month | 15 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The manuscript submission was delayed and is currently in progress.
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
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2026 | Year | 07 | Month | 15 | Day |
Last modified on
| 2026 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067050
