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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
