UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061840 |
|---|---|
| Receipt number | R000070754 |
| Scientific Title | Psychological and neural mechanisms of the effects of the Newborn Behavioral Observations (NBO) system on improving caregivers' mental health |
| Date of disclosure of the study information | 2026/06/09 |
| Last modified on | 2026/06/09 11:17:24 |
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Basic information
Public title
Study on the effects of care using the Newborn Behavioral Observations (NBO) system
Acronym
Effects of Care Using the Newborn Behavioral Observations (NBO) System
Scientific Title
Psychological and neural mechanisms of the effects of the Newborn Behavioral Observations (NBO) system on improving caregivers' mental health
Scientific Title:Acronym
Effects of care using the NBO system for primiparous mothers
Region
| Japan |
Condition
Condition
primiparous mothers and their firstborn infants aged approximately 8-12 weeks
Classification by specialty
| Pediatrics | Nursing | Not applicable |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine how care using the Newborn Behavioral Observations (NBO) system affects changes in neurobiological foundations, such as maternal mental health and facial expression recognition ability, in parents and their infants aged up to approximately 3 months.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Screening for maternal postpartum depression and evaluation using the Mother-Infant Bonding Scale (MIBS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Implementation of care using the Newborn Behavioral Observations (NBO) system for parents and their infants
Interventions/Control_2
Control Group 1:Existing data stored in the relevant laboratory (without NBO intervention; with available MRI data)
Participants must meet all of the following criteria.
1.Aged 18 years or older
2.Women who have given birth to their first child
3.Handedness: not specified
4.Mothers within 14 weeks postpartum as of the date of assessment
Interventions/Control_3
Control Group 2: Control Group 2 is established to collect data on psychological assessment items not measured in Control Group 1, as well as the Implicit Association Test.
(Without NBO intervention; without MRI data; with Implicit Association Test)
Participants must meet all of the following criteria.
Aged 18 years or older
Women who have given birth to their first child
Handedness: not specified
Mothers within 14 weeks postpartum as of the date of assessment
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
Female
Key inclusion criteria
Mother:Participants must meet all of the following criteria.
1.Aged 18 years or older
2.Primiparous women (women who have given birth to their first child)
3.Mothers within 14 weeks postpartum by the day of the NBO session (for preterm infants, the corrected age must be within 14 weeks)
4.Those who are able to visit Fukui University Hospital with their infant at around 8 to 12 weeks postpartum
5.Handedness: Any (No restriction)
6.Those who have received a sufficient explanation regarding participation in this study, have reached a full understanding, and have provided voluntary written informed consent based on their own free will
Key exclusion criteria
Mother:Candidates who meet any of the following criteria will be excluded from the study:
1.Individuals with an implanted cardiac or neural pacemaker
2.Individuals with metallic implants in their body, such as arterial clips
3.Individuals wearing orthodontic appliances (braces)
4.Individuals who experience claustrophobia (fear of enclosed spaces) or achluophobia (fear of dark spaces)
5.Individuals with a history of conditions such as a hernia who are unable to maintain the same posture for an extended period
6.Individuals with severe physical or mental disorders
7.Any other individuals judged by the principal investigator or sub-investigator to be unsuitable as a study participant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akemi |
| Middle name | |
| Last name | Tomoda |
Organization
University of Fukui
Division name
Research Center for Child Mental Development
Zip code
910-1193
Address
23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL
0776-61-8677
atomoda@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Satsuki |
| Middle name | |
| Last name | Dateoka |
Organization
University of Fukui
Division name
Research Center for Child Mental Development
Zip code
910-1193
Address
23-3 Matsuoka Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan
TEL
0776-61-8677
Homepage URL
sdateoka@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
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
The Research Ethics Committee of University of Fukui
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji-cho, Yoshida-gun, Fukui Prefecture
Tel
0776613111
rinsho-rinri@ml.u-fukui.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 | 06 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 30 | 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 | 06 | Month | 09 | Day |
Last modified on
| 2026 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070754
