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

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 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


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

Value
https://center6.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