UMIN-CTR Clinical Trial

Basic information
Public title	Psychological support for elementary school students who use after-school day services through the Clay Dialogue Act
Acronym	Psychological support for elementary school students who use after-school day services through the Clay Dialogue Act
Scientific Title	Psychological support for elementary school students who use after-school day services through the Clay Dialogue Act
Scientific Title:Acronym	Psychological support for elementary school students who use after-school day services through the Clay Dialogue Act
Region	Japan

Condition
Condition	developmental disorder
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	measure the effectiveness of psychological assistance on stress reduction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	stress response scale for children
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	introduction of clay dialogues
Interventions/Control_2
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	6 years-old <=
Age-upper limit	12 years-old >=
Gender	Male and Female
Key inclusion criteria	an elementary school student who attends a day service after school
Key exclusion criteria	a child who is scheduled to leave school in the middle of a study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Ayaka Middle name Last name Furuichi
Organization	International Graduate School of Health and Welfare
Division name	Medical Welfare Research Department clinical psychology major
Zip code	107-8402
Address	Akasaka 4-1-26 Minato Ward, Tokyo
TEL	03-5574-3900
Email	21s4016@g.iuhw.ac.jp

Public contact
Name of contact person	1st name Ayaka Middle name Last name furichi
Organization	International Graduate School of Health and Welfare
Division name	Medical Welfare Research Department clinical psychology major
Zip code	107-8402
Address	Akasaka 4-1-26 Minato Ward, Tokyo
TEL	03-5574-3900
Homepage URL
Email	21s4016@g.iuhw.ac.jp

Sponsor
Institute	International University of Health and Welfare
Institute
Department

Funding Source
Organization	International University of Health and Welfare
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	International University of Health and Welfare
Address	Akasaka 4-1-26 Minato Ward, Tokyo
Tel	03-5574-3900
Email	21s4016@g.iuhw.ac.jp

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	2022 Year 12 Month 01 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	Preinitiation
Date of protocol fixation	2022 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2022 Year 06 Month 01 Day
Last follow-up date	2022 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 03 Month 27 Day
Last modified on	2022 Year 03 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053889