UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037434
Receipt No. R000042667
Scientific Title Effects of collaboration between care worker and occupational therapist on quality of life in children with developmental disorder in after-school childcare program: A pilot study
Date of disclosure of the study information 2019/07/21
Last modified on 2019/11/05

* 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 Effects of collaboration care on children with developmental disorder in after-school childcare program
Acronym Effects of collaboration care on children with developmental disorder in after-school childcare program
Scientific Title Effects of collaboration between care worker and occupational therapist on quality of life in children with developmental disorder in after-school childcare program: A pilot study
Scientific Title:Acronym Effects of collaboration between care worker and occupational therapist on quality of life in children with developmental disorder in after-school childcare program: A pilot study
Region
Japan

Condition
Condition develpomental disorder
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the effects of collaboration between care worker and occupational therapist on quality of life in children with developmental disorder in after-school childcare program
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Strengths and Difficulties Questionnaire Japanese Version: teacher scale
Emotional Intelligence Scale: teacher scale
kid-KINDL Japanese Version
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
Other
Interventions/Control_1 collaboration between care worker and occupational therapist
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 children belonging to after school child care faicility more than three month
children with developmental disorder
Being agreed with participation in this study
Key exclusion criteria with obvious physical disability
with obvious mental retardation
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Ryuji
Middle name
Last name Kobayashi
Organization Tokyo Metropolitan University Guraduate school of Human Health Sciences
Division name Department of Occupational Therapy
Zip code 116-8551
Address 7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL 03-3819-1211
Email ryukoba@tmu.ac.jp

Public contact
Name of contact person
1st name Ryuji
Middle name
Last name Kobayashi
Organization Tokyo Metropolitan University Guraduate school of Human Health Sciences
Division name Department of Occupational Therapy
Zip code 116-8551
Address 7-2-10, Higashiogu, Arakawa-ku, Tokyo, Japan
TEL 03-3819-1211
Homepage URL
Email ryukoba@tmu.ac.jp

Sponsor
Institute Tokyo Metropolitan University
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology
Grants-in-Aid for scientific research expenses
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Okayama prefectural association of after school child care facility
Address nakashima 760-1, kurashiki, Okayama, Japan
Tel 080-6315-9933
Email gakudou@mx6.tiki.ne.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
2019 Year 07 Month 21 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 20
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
2019 Year 05 Month 16 Day
Date of IRB
2019 Year 06 Month 20 Day
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2019 Year 12 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 20 Day
Last modified on
2019 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042667

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.