UMIN-CTR Clinical Trial

Basic information
Public title	Child-rearing support e-learning program development for parents with mental disorders
Acronym	Child-rearing support program
Scientific Title	Child-rearing support e-learning program development for parents with mental disorders
Scientific Title:Acronym	Child-rearing support program
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Nursing Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to develop an e-learning program for practitioners regarding child-rearing support for parents with mental disorders and their family members.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Support coping difficulty / possibility scale
Key secondary outcomes	Achievement of program goals Skills related to mental health issues

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are 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	Other
Interventions/Control_1	About 180 minutes of e-learning. It includes mental illness and support agencies, illness / disability characteristics and child-rearing, support needs of the parties concerned, experience and support of children / spouses, and specific support methods.
Interventions/Control_2	No intervention.
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	A full-time public health nurses in charge of maternal and child health who works at a health center and has 10 years or less of experience.
Key exclusion criteria	People who cannot perform web surveys or watch e-learning video.
Target sample size	176

Research contact person
Name of lead principal investigator	1st name Masako Middle name Last name Kageyama
Organization	Osaka University
Division name	Institute of Advanced Co-Creation Studies/ Division of Health Sciences, Graduate School of Medicine
Zip code	565-0871
Address	Yamadaoka 1-7, Suita, Osaka, Japan, 565-0871
TEL	06-6879-2553
Email	kageyama@sahs.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Masako Middle name Last name Kageyama
Organization	Osaka University
Division name	Institute of Advanced Co-Creation Studies/ Division of Health Sciences, Graduate School of Medicine
Zip code	565-0871
Address	Yamadaoka 1-7, Suita, Osaka, Japan, 565-0871
TEL	06-6879-2553
Homepage URL
Email	kageyama@sahs.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethical Review Board Osaka University Hospital
Address	Yamadaoka 2-2, Suita, Osaka, Japan
Tel	06-6210-8290
Email	rinri-jim@dmi.med.osaka-u.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	2021 Year 11 Month 01 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	2021 Year 10 Month 15 Day
Date of IRB	2021 Year 10 Month 19 Day
Anticipated trial start date	2021 Year 11 Month 10 Day
Last follow-up date	2022 Year 03 Month 19 Day
Date of closure to data entry	2022 Year 03 Month 19 Day
Date trial data considered complete	2022 Year 03 Month 19 Day
Date analysis concluded	2022 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2021 Year 10 Month 15 Day
Last modified on	2022 Year 04 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051808