UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004262 |
|---|---|
| Receipt number | R000004559 |
| Scientific Title | An itervention study focused on maternal emotional sensitivity which examine effects on mother-child attachment and children's personality |
| Date of disclosure of the study information | 2010/09/24 |
| Last modified on | 2010/09/24 17:52:11 |
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Basic information
Public title
An itervention study focused on maternal emotional sensitivity which examine effects on mother-child attachment and children's personality
Acronym
An intervention study about maternal emotional sensitivity
Scientific Title
An itervention study focused on maternal emotional sensitivity which examine effects on mother-child attachment and children's 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 |
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 mother and child mental health.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
"TOTAL STRESS" of the Parenting Stress Index
Key secondary outcomes
The other subscales of the Parenting Stress Index, Internal T score, External T score and the Total T score of the T score and the Total T score of the Child Behavior Checklist
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group: The mothers and the children 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 control group: The mothers and the children will have ordinary 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 couples of mother and child who understand the objectives of this study and consent to participate in
Key exclusion criteria
Nothing
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
4-1 Seiryou-machi, Aoba-ku, Sendai-shi, Miyagi-ken 980-8575, Japan
TEL
00810227177988
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tohoku University Hospital
Division name
University Hospital Medical Information Center
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
University Hospital Medical Information Center, Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Functional Brain Imaging, IDAC, Tohoku University
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 24 | 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 24 | Day |
Last modified on
| 2010 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004559
