UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033664 |
|---|---|
| Receipt number | R000038378 |
| Scientific Title | A study on the development of infant -2 |
| Date of disclosure of the study information | 2018/08/20 |
| Last modified on | 2026/04/10 09:29:26 |
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Basic information
Public title
A study on the development of infant -2
Acronym
A study on the development of infant -2
Scientific Title
A study on the development of infant -2
Scientific Title:Acronym
A study on the development of infant -2
Region
| Japan |
Condition
Condition
Healthy infants and Healthy caregivers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Understanding the development of infant
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of infant's development
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Practice in usual childcare for 3 weeks after attending a seminar.
Interventions/Control_2
To take childcare as usual for 3 weeks.
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
| 6 | months-old | <= |
Age-upper limit
| 12 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
(infant)
-Healthy infants
(infant's caregivers)
-Healthy females
Key exclusion criteria
-Infant with chronic sickness.
-Infant with infectious disease.
-Caregiver who can't understand,read and write Japanese.
-Infant and its caregiver who are judged as unsuitable participant by investigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Haramizu |
Organization
Kao Corporation
Division name
Kansei Science Research
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL
+81-3-5630-9889
haramizu.satoshi@kao.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Haramizu |
Organization
Kao Corporation
Division name
Kansei Science Research
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan
TEL
+81-3-5630-9889
Homepage URL
haramizu.satoshi@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ritsumeikan university
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
立命館大学（大阪いばらきキャンパス）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/pacjpa/85/0/85_PO-033/_pdf
Publication of results
Unpublished
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/pacjpa/85/0/85_PO-033/_pdf
Number of participants that the trial has enrolled
20
Results
We evaluated an interaction-focused intervention for mothers of 1-year-olds. Twenty dyads (control n=8 intervention n=12) were videotaped during a lab diaper-change task and mothers completed the PSI (Exp1). The intervention group attended a seminar, practiced for 3 weeks, and returned for the same procedure (Exp2). Group Time ANOVA on coded videos showed increased maternal smiling and speech, reduced Parent-domain stress, and attenuated increases in Child-domain stress.
Results date posted
| 2026 | Year | 04 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Mother-infant dyads were enrolled.Infants were firstborn children and were approximately 12-14 months of age at the time of observation.
Participant flow
Written informed consent was obtained from 20 mother-infant dyads with infants aged 12-14 months at study entry.Dyads were then assigned to a control group or an intervention group. Mothers in the intervention group attended a seminar on parenting/parent-child interaction and implemented the content in daily life for 3 weeks. Dyads were invited to visit the laboratory at Ritsumeikan University, Ibaraki Campus, to complete study procedures before and after the intervention.
Adverse events
None
Outcome measures
Trained raters coded maternal and infant facial expressions and scored items from the Interaction Rating Scale (IRS) as indices of dyadic interaction including speech rate and the content of maternal utterances. Maternal parenting stress was assessed using the Parenting Stress Index (PSI).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2020 | 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
| 2018 | Year | 08 | Month | 07 | Day |
Last modified on
| 2026 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038378
