UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of consultation focusing on nursing care by occupational therapist
Title of the study (Brief title)	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	Sayaka Yamaguchi
Organization	Nonprofit organization Hablis,
Division name	Hablis
Address	1-168-1, Uchihara, Ohgaki-city, Gifu
TEL	0584-84-3800
Email	sayakakayasakayasa@gmail.com

Public contact
Name of contact person	Sayaka Yamaguchi
Organization	Nonprofit organization Hablis,
Division name	Hablis
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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