UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005741 |
|---|---|
| Receipt number | R000006790 |
| Scientific Title | An intervention study about maternal emotional sensitivity which assesses effects on attachment representation and child personality |
| Date of disclosure of the study information | 2011/06/08 |
| Last modified on | 2011/06/29 04:51:27 |
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Basic information
Public title
An intervention study about maternal emotional sensitivity which assesses effects on attachment representation and child personality
Acronym
An intervention study about maternal emotional sensitivity
Scientific Title
An intervention study about maternal emotional sensitivity which assesses effects on attachment representation and child personality
Scientific Title:Acronym
An intervention study about maternal emotional sensitivity
Region
| Japan |
Condition
Condition
Typically developped preschool children and their mothers
Classification by specialty
| Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will test the efficacy of an intervention program focused on maternal emotional sensitivity using mother and child's cooperative activities for attachment representation and child personality.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Novelty Seeking (Japanese version fo the Preschool Temperament & Character Inventory)
Key secondary outcomes
The subscales of the Parent Bonding Inventory, the ECR-GO, the RQ and the PTCI (except for Novelty seeking)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The participants of the intervention group will cook pancakes once a week, for six weeks. When cooking pancakes, the mothers will be asked to take care of matarnal emotional sensitivity, and they praise their childre what they did warmly.
Interventions/Control_2
The participants of the control group have ordinaly daily life.
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
| 4 | years-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The children and their mothers who attend on the explanation meeting of this study and give informed concents will be included to this study.
Key exclusion criteria
The exclusion criteria of this study was a current clinically severe illness or disorder which made it impossible to perform the intervention program.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuta Kawashima |
Organization
IDAC, Tohoku University
Division name
Smart Aging International Research Center
Zip code
Address
Seiryou-machi 4-1, Aoba-ku, Sendai-shi, Miyagi-ken 980-8575, Japan
TEL
022(717)7988
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Tachibana |
Organization
IDAC, Tohoku University
Division name
Smart Aging International Research Center
Zip code
Address
Seiryou-machi 4-1, Aoba-ku, Sendai-shi, Miyagi-ken 980-8575, Japan
TEL
022(717)7988
Homepage URL
Sponsor or person
Institute
Smart Aging International Research Center, IDAC, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
親子の感情応答性向上が親子の愛着や子供の性格・気質に及ぼす影響についての生活介入研究
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 08 | Day |
Last modified on
| 2011 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006790
