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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004261
Receipt No. 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

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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
Institute Smart Aging International Research Center, IDAC, Tohoku University
Institute
Department

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
URL(English) https://upload.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


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