UMIN-CTR Clinical Trial

Basic information
Public title	E-learning teacher training for children with or showing a tendency of developmental disorders in the regular classroom: a randomised controlled feasibility study
Acronym	E-learning teacher training for children with or showing a tendency of developmental disorders in the regular classroom: a randomised controlled feasibility study
Scientific Title	E-learning teacher training for children with or showing a tendency of developmental disorders in the regular classroom: a randomised controlled feasibility study
Scientific Title:Acronym	E-learning teacher training for children with or showing a tendency of developmental disorders in the regular classroom: a randomised controlled feasibility study
Region	Japan

Condition
Condition	Neurodevelopmental disorders
Classification by specialty	Pediatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study implements e-learning teacher training (e-LTT) for regular primary school teachers and checks the feasibility of the research procedure and the acceptability of the intervention program, as a feasibility study.
Basic objectives2	Others
Basic objectives -Others	This study checks the feasibility of the research procedure and the acceptability of the intervention program.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-Feasibility of research procedures and acceptability of the intervention program Evaluation time (10 weeks after the start of the intervention) -Teachers' frequency of use of classroom management strategies Evaluation time (Before the intervention, 10 weeks after the start of the intervention, 16 weeks after the start of the intervention)
Key secondary outcomes	-Teachers' performance in taking e-LTT Evaluation time (10 weeks after the start of the intervention) -Teachers' self-efficacy, -Teachers' stress, -Teachers' burnout Evaluation time (Before the intervention, 10 weeks after the start of the intervention, 16 weeks after the start of the intervention)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Maneuver
Interventions/Control_1	Intervention period: 10 weeks Intervention content: e-Learning Teacher Training Program (20 minutes of video-learning times 5, 70 minutes of consultation with TV conference system times 5)
Interventions/Control_2	Control group: after the 10 weeks of the intervention group's receiving training and 6 weeks of follow-up, this group will be able to attend the program for 20 minutes times 5 of video-learning.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Regular classroom teachers who have children in their class who have a diagnosis or tendency toward ADHD or ASD and wish to learn how to deal with them
Key exclusion criteria	*If they have taken / will take TT within the past 2 months to the end of the study *If they are not working for more than 4 days a week from the time of recruitment to the end of follow-up data collection *If they have difficulty attending the program in Japanese *If they have a serious mental illness that makes it difficult for them to participate in TT
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Atsuko Middle name Last name Ishii
Organization	United Graduate School of Child Development, Osaka University
Division name	Molecular Research Center for Children's Mental Development
Zip code	565-0871
Address	2-2, Yamadaoka, Suita City, Osaka
TEL	06-6879-3863
Email	aishii@kokoro.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Atsuko Middle name Last name Ishii
Organization	United Graduate School of Child Development, Osaka University
Division name	Molecular Research Center for Children's Mental Development
Zip code	565-0871
Address	2-2, Yamadaoka, Suita City, Osaka
TEL	06-6879-3863
Homepage URL
Email	aishii@kokoro.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
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	Graduate School of Human Science, Osaka University
Address	1-2, Yamadaoka, Suita City, Osaka
Tel	06-6879-8120
Email	n/a

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 12 Month 13 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	Open public recruiting
Date of protocol fixation	2022 Year 07 Month 15 Day
Date of IRB	2022 Year 08 Month 02 Day
Anticipated trial start date	2022 Year 12 Month 13 Day
Last follow-up date	2025 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	2022 Year 12 Month 13 Day
Last modified on	2022 Year 12 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056532