UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049185 |
|---|---|
| Receipt number | R000056018 |
| Scientific Title | Effects of cllaboration between after-school childcare program and occupational therapists on children's mental health |
| Date of disclosure of the study information | 2022/10/12 |
| Last modified on | 2023/04/12 10:05:45 |
* 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 cllaboration between after-school childcare program and occupational therapists on children's mental health
Acronym
Effects of cllaboration between after-school childcare program and occupational therapis
Scientific Title
Effects of cllaboration between after-school childcare program and occupational therapists on children's mental health
Scientific Title:Acronym
Effects of cllaboration between after-school childcare program and occupational therapis
Region
| Japan |
Condition
Condition
develiopmental disorder
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of collaboration between after-school childcare program and occupational theraists
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Strength and Difficulties Questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
consalutation by occupational therapists
3 times
Interventions/Control_2
no treatment
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
| 7 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
diagnosis of developmental disorder
Key exclusion criteria
approval of parent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Kobayashi |
Organization
Okayama healthcare Professional University
Division name
Department of Occupational Therapy, Faculty of Health Sciences
Zip code
700-0913
Address
3-2-18, Daiku ,Okayama
TEL
086-233-8020
kobayashi@opu.ac.jp
Public contact
Name of contact person
| 1st name | Ryuji |
| Middle name | |
| Last name | Kobayashi |
Organization
Okayama Healthcare Professional University
Division name
Department of Occupational Therapy, Faculty of Health Sciences
Zip code
700-0913
Address
3-2-18, Daiku ,Okayama
TEL
086-233-8020
Homepage URL
kobayashi@opu.ac.jp
Sponsor or person
Institute
Okayama healthcare Professional University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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 Healtcare Professional University Institutional Review Board
Address
3-2-18, Daiku ,Okayama
Tel
086-233-8020
somu@opu.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 | 10 | Month | 12 | 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
36
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
| 2022 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 02 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 11 | Day |
Last modified on
| 2023 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056018
