UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002265
Receipt number R000002773
Scientific Title A group randomized controlled trial of a play program for mother and child to enhance their mental health and children's cognitive development
Date of disclosure of the study information 2009/07/29
Last modified on 2019/02/03 21:19:41

* 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

A group randomized controlled trial of a play program for mother and child to enhance their mental health and children's cognitive development

Acronym

A group randomized controlled trial of a play program for mother and child to enhance their mental health and children's cognitive development

Scientific Title

A group randomized controlled trial of a play program for mother and child to enhance their mental health and children's cognitive development

Scientific Title:Acronym

A group randomized controlled trial of a play program for mother and child to enhance their mental health and children's cognitive development

Region

Japan


Condition

Condition

Typically developped preschool children

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Enhancing children's cognitive development and improving mother and child's mental health

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Parenting Stress Index
New S-S intelligence test
DAM Goodenough draw-a-man intelligence test

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

The intervention group: The participants performs the play program for ten miniutes a day, five days a week, for three months.

Interventions/Control_2

The control group: The participants 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

3 years-old <=

Age-upper limit

6 years-old >

Gender

Male and Female

Key inclusion criteria

The parents and children who understand the explanation of the present study and understand the explanation of the present study and consent to participate in

Key exclusion criteria

Nothing

Target sample size

250


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryuta Kawashima

Organization

IDAC, Tohoku University

Division name

Department of Functional Brain Imaging

Zip code


Address

Seiryou-machi4-1, Aoba-ku, Sendai-shi, Miyagi-ken

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

IDAC, Tohoku University

Division name

Department of Functional Brain Imaging

Zip code


Address


TEL


Homepage URL


Email

tatibana@idac.tohoku.ac.jp


Sponsor or person

Institute

Department of Functional Brain Imaging, IDAC, Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

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

2009 Year 07 Month 29 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0038238

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

Completed

Date of protocol fixation

2009 Year 07 Month 10 Day

Date of IRB


Anticipated trial start date

2009 Year 08 Month 01 Day

Last follow-up date

2014 Year 08 Month 01 Day

Date of closure to data entry

2014 Year 08 Month 01 Day

Date trial data considered complete

2014 Year 09 Month 01 Day

Date analysis concluded

2014 Year 09 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 07 Month 29 Day

Last modified on

2019 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002773


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name