UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046260 |
|---|---|
| Receipt number | R000052787 |
| Scientific Title | Validation of an ICT-based intervention program for mental health promotion among Chinese women in Japan: a quasi-experimental study with control group pretest-posttest |
| Date of disclosure of the study information | 2021/12/23 |
| Last modified on | 2023/05/12 17:26:09 |
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Basic information
Public title
a study for mental health promotion practice among Chinese women in Japan
Acronym
a study for mental health promotion practice among Chinese women in Japan
Scientific Title
Validation of an ICT-based intervention program for mental health promotion among Chinese women in Japan: a quasi-experimental study with control group pretest-posttest
Scientific Title:Acronym
Validation of an ICT-based intervention program for mental health promotion among Chinese women in Japan
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the intervention program's validation and examine the usability of the ICT-based application.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Using the 12-items general health questionnaire (Globerg,1972) to evaluate mental health
2.Using the center for epidemiologic studies depression scale (Radloff, 1977) to evaluate depression
3.Using the multidimensional scale of received social support (Zimet,1988) to evaluate social support.
4. Using the child-rearing stress scale to evaluate the parenting stress (Shimizu,2001)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Other |
Interventions/Control_1
Attendinding parentig workshops
Interventions/Control_2
Using the developed apprication to obtain child-rearing information
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
Female
Key inclusion criteria
1.Chinese women living in Japan
2.Age older than 20 years
3.Women with at least one child under the age of 6 or pregnant
4.Women able to speak, read, and understand Chinese
Key exclusion criteria
1.Women had intellectual disabilities
2.women did not complete all program contents or fill in the pre- and post-questionnaris
3.Women were unable to read the materials using electronic equipment
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Sato |
Organization
Hokkaido University
Division name
Faculty of Health Sciences,
Zip code
0600812
Address
Kita 12 Nishi 5, Kita-Ku, Sapporo, Hokkaido
TEL
+81117063378
ys@hs.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Sato |
Organization
Hokkaido University
Division name
Faculty of Health Sciences,
Zip code
0600812
Address
Kita 12 Nishi 5, Kita-Ku, Sapporo, Hokkaido
TEL
+81117063378
Homepage URL
ys@hs.hokudai.ac.jp
Sponsor or person
Institute
sato Laboratory
Institute
Department
Personal name
Funding Source
Organization
Program for One Health Frontier of Graduate School,Hokkaido University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University,
Address
Kita 12 Nishi 5, Kita-Ku, Sapporo, Hokkaido
Tel
+81117063378
ys@hs.hokudai.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 | 12 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052787
