UMIN-CTR Clinical Trial

Basic information
Public title	The influence of consultation by occupational therapist on after-school child care-workers -survey by questionnaire-
Acronym	The influence of consultation by occupational therapist on after-school child care-workers -survey by questionnaire-
Scientific Title	The influence of consultation by occupational therapist on after-school child care-workers -survey by questionnaire-
Scientific Title:Acronym	The influence of consultation by occupational therapist on after-school child care-workers -survey by questionnaire-
Region	Japan

Condition
Condition	Autism Spectrum Disorder Attention Deficit Hyperactivity Disorder Developmental Coordination Disorder Learning Disorder Communication Disability
Classification by specialty	Rehabilitation medicine Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The occupational therapist consulted on after-school child care-workers about understanding and correspondence of children with developmental disabilities. We will examine the differences in the responses of the questionnaires between the supporters who received it and those who do not.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Numerical change of questionnaire
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	after-school child care-workers
Key exclusion criteria	outside after-school child care-workers
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Yoshihiko Middle name Last name Morikawa
Organization	Kawasaki Junior College of Rehabilitaiton
Division name	Department of Occupational Therapy
Zip code	7010192
Address	672, Matsushima, Kurashiki city, Okayama prefecture
TEL	086-462-1111
Email	morikawa@med.kawasaki-m.ac.jp

Public contact
1st name of contact person	1st name Yoshihiko Middle name Last name Morikawa
Organization	Kawasaki Junior College of Rehabilitaiton
Division name	Department of Occupational Therapy
Zip code	7010192
Address	672, Matsushima, Kurashiki city, Okayama prefecture
TEL	086-462-1111
Homepage URL
Email	morikawa@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Junior College of Rehabilitaiton
Institute
Department

Funding Source
Organization	Association of the School childcare Okayama prefecture
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	Kawasaki Junior College of Rehabilitaiton
Address	672, Matsushima, Kurashiki city, Okayama prefecture
Tel	0864621111
Email	morikawa@med.kawasaki-m.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	2018 Year 04 Month 16 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	66
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	2018 Year 05 Month 15 Day
Date of IRB	2018 Year 05 Month 28 Day
Anticipated trial start date	2018 Year 05 Month 31 Day
Last follow-up date	2019 Year 04 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The recruitment of after-school children's clubs will be conducted through association of school childcare okayama prefecture.

Management information
Registered date	2018 Year 04 Month 12 Day
Last modified on	2019 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036738