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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004262
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute University Hospital Medical Information Center, Tohoku University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004559

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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