UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037434 |
|---|---|
| Receipt number | 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 | 2020/07/19 20:03:11 |
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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
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
ryukoba@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
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
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
Completed
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
| 2020 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
