UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004261
Receipt number R000005111
Scientific Title An intervention study of a play program for preschool children and their mothers to enhance their mental health and children's cognitive abilities
Date of disclosure of the study information 2010/09/24
Last modified on 2010/09/24 17:33:03

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Basic information

Public title

An intervention study of a play program for preschool children and their mothers to enhance their mental health and children's cognitive abilities

Acronym

An intervention study of a play program for preschool children and their mothers

Scientific Title

An intervention study of a play program for preschool children and their mothers to enhance their mental health and children's cognitive abilities

Scientific Title:Acronym

An intervention study of a play program for preschool children and their mothers

Region

Japan


Condition

Condition

Typically developed preschool children and their mothers

Classification by specialty

Pediatrics Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Enhancing typically developed preschool children's cognitive abilities and improving mothers' and children's mental health

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Expressive Attention (DN-CAS)

Key secondary outcomes

Planned Connections (DN-CAS)
Parenting Stress Index
Preschool Temperament & Character Inventory


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

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

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

The participants of the intervention group perfrom the play program for ten miniutes a day, five times a week, for three months.

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

5 years-old <=

Age-upper limit

6 years-old >=

Gender

Male and Female

Key inclusion criteria

Those who are agree with joining the intervention study among the third grande children in Wakakusa kindergarten(Sendai) and their mothers

Key exclusion criteria

None

Target sample size

200


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

+81-22-717-7988

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoshiyuki Tachibgana

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


Email

tatibana@idac.tohoku.ac.jp


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


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

わかくさ幼稚園(宮城県)


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

2010 Year 06 Month 15 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date

2011 Year 03 Month 01 Day

Date of closure to data entry

2011 Year 03 Month 01 Day

Date trial data considered complete

2011 Year 03 Month 01 Day

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=R000005111


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name