UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062408 |
|---|---|
| Receipt number | R000071420 |
| Scientific Title | Factors Associated with Maternal-Infant Bonding in Pregnant and Postpartum Women Receiving Psychiatric Care and the Effects of Newborn Behavioral Observations (NBO) Intervention |
| Date of disclosure of the study information | 2026/07/30 |
| Last modified on | 2026/07/30 14:49:00 |
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Basic information
Public title
Factors Associated with Maternal-Infant Bonding in Pregnant and Postpartum Women Receiving Psychiatric Care and the Effects of Newborn Behavioral Observations (NBO) Intervention
Acronym
Mother-Infant Bonding and the Effects of the NBO Intervention in Pregnant and Postpartum Women Receiving Psychiatric Care
Scientific Title
Factors Associated with Maternal-Infant Bonding in Pregnant and Postpartum Women Receiving Psychiatric Care and the Effects of Newborn Behavioral Observations (NBO) Intervention
Scientific Title:Acronym
Mother-Infant Bonding and the Effects of the NBO Intervention in Pregnant and Postpartum Women Receiving Psychiatric Care
Region
| Japan |
Condition
Condition
Psychiatric disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate factors associated with impaired maternal-infant bonding, including childhood trauma, social cognitive functioning, autism spectrum disorder (ASD) traits, lifestyle factors such as screen time, partner-related factors, and ASD traits in the infant. To evaluate the effects of the Newborn Behavioral Observations (NBO) intervention on maternal-infant bonding and infant social development.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mother-to-Infant Bonding Scale (MIBS-J): Third trimester of pregnancy, 1 month postpartum, 4 months postpartum, and 16 months postpartum.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants receive the Newborn Behavioral Observations (NBO) intervention in addition to usual psychiatric care.
Interventions/Control_2
Participants receive usual psychiatric care without the NBO intervention.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pregnant women aged 18 years or older who received psychiatric care at our hospital during the study period, their spouses or partners, and their infants.
Key exclusion criteria
Patients who did not provide informed consent, those deemed unsuitable for participation by the attending physician, and mothers younger than 18 years of age and their spouses or partners.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Kuramitsu |
Organization
Ehime University Hospital
Division name
Department of Neuropsychiatry
Zip code
7910295
Address
454 Shitsukawa, Toon, Ehime
TEL
0899605315
kuramitsu.ayumi.np@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Kuramitsu |
Organization
Ehime University Hospital
Division name
Department of Neuropsychiatry
Zip code
7910295
Address
454 Shitsukawa, Toon, Ehime
TEL
0899605315
Homepage URL
kuramitsu.ayumi.np@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
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
Institutional Review Board,Ehime University Hospital
Address
454 Shitsukawa, Toon, Ehime
Tel
0899605172
rinri@m.ehime-u.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 | 30 | 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
| 2026 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2030 | 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 | 30 | Day |
Last modified on
| 2026 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071420
