UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045765 |
|---|---|
| Receipt number | R000051808 |
| Scientific Title | Child-rearing support e-learning program development for parents with mental disorders |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2022/04/15 10:50:33 |
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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
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
kageyama@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051808
