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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035795
Receipt No. R000040777
Scientific Title The effect of consultation focusing on nursing care by occupational therapist
Date of disclosure of the study information 2019/02/07
Last modified on 2019/02/07

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Basic information
Public title The effect of consultation focusing on nursing care by occupational therapist
Acronym Effect of Collaborative Goal-Setting with Teachers
Scientific Title The effect of consultation focusing on nursing care by occupational therapist
Scientific Title:Acronym Effect of Collaborative Goal-Setting with Teachers
Region
Japan

Condition
Condition Adult and child
Classification by specialty
Rehabilitation medicine Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to examine the feasibility and effect of an indirect intervention which includes teacher consultation a visiting SBOT.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Canadian Occupational Performance Measure (COPM),
Key secondary outcomes Goal Attainment Scaling (GAS), Strengths and Difficulties Questionnaire (SDQ)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Evaluation and goal-setting: The OTR observes child's school life for an hour based on the SDQ and pre-document. The OTR and teacher discuss the individual- and occupational-based goal by using ADOC-S. The OTR respects the teacher's autonomy and educational policy. In selected goals, teacher rates the performance score and satisfaction using COPM-card.

Planning: The OTR and teacher discuss goals and the intervention plan. OTR encourages the teacher to share opinion and provides suggestions, leading the teacher to consider the intervention plan. The OTR and teacher rate the GAS from -2 to +2. The intervention is planned and provided by teacher.

Follow-up: The OTR reviewed the intervention progress with the teacher using GAS [The GAS was not used to assess outcomes].
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
3 years-old <=
Age-upper limit
6 years-old >=
Gender Male and Female
Key inclusion criteria Children in their classroom who: (1) had no diagnosed developmental disorders; (2) were not currently receiving services; but (3) where the teacher recognized developmental delays and the need for special education; and (4) at least one indicated "high need" subcategory of the Strengths and Difficulties Questionnaire (SDQ).
Key exclusion criteria Non
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sayaka Yamaguchi
Organization Nonprofit organization Hablis,
Division name Hablis
Zip code
Address 1-168-1, Uchihara, Ohgaki-city, Gifu
TEL 0584-84-3800
Email sayakakayasakayasa@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Sayaka Yamaguchi
Organization Nonprofit organization Hablis,
Division name Hablis
Zip code
Address 1-168-1, Uchihara, Ohgaki-city, Gifu
TEL 0584-84-3800
Homepage URL
Email sayakakayasakayasa@gmail.com

Sponsor
Institute Nonprofit organization Hablis,
Institute
Department

Funding Source
Organization Kakenhi Grant from the Japanese Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 町立幼稚園および保育所(岐阜県関ヶ原町)

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 07 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 Completed
Date of protocol fixation
2014 Year 09 Month 29 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 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 02 Month 07 Day
Last modified on
2019 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040777

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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