UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000029866 |
|---|---|
| Receipt number | R000034109 |
| Scientific Title | Development of cognitive behavior therapy program to reduce parenting stress |
| Date of disclosure of the study information | 2018/11/07 |
| Last modified on | 2017/11/07 18:25:03 |
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Basic information
Public title
Development of cognitive behavior therapy program to reduce parenting stress
Acronym
Development of cognitive behavior therapy program to reduce parenting stress
Scientific Title
Development of cognitive behavior therapy program to reduce parenting stress
Scientific Title:Acronym
Development of cognitive behavior therapy program to reduce parenting stress
Region
| Japan |
Condition
Condition
Pregnant women
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Develop programs based on cognitive behavioral therapy to alleviate child rearing stress.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We referred to cognitive behavioral therapy for depressed patients and created a program for childcare stress. The program will be improved based on opinions from pregnant women.
The first: When mothers' class is in the middle of pregnancy. The 2nd: When mothers' class is in the late pregnancy. Third time: during one month checkup.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
We will conduct an hour's program for pregnant women visiting mothers' class.The first: When mothers' class is in the middle of pregnancy. The 2nd: When mothers' class is in the late pregnancy. Third time: during one month checkup.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Pregnant women who can receive all three programs Pregnant women
Key exclusion criteria
Pregnant women suffering from mental illness.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sankai Chihoko |
Organization
University of Tsukuba Hospital
Division name
Nursing Department
Zip code
Address
2-1-1 Amakubo, Tsukuba, Ibaraki ,Japan
TEL
029-853-7671
sankaichihoko@ob.md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sankai Chihoko |
Organization
University of Tsukuba Hospital
Division name
Nursing Department
Zip code
Address
2-1-1 Amakubo, Tsukuba, Ibaraki ,Japan
TEL
029-853-7671
Homepage URL
sankaichihoko@ob.md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of Science
Ministry of education, Culture, Sports, Science and Technology - Japan
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
Address
Tel
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
椎名産婦人科（茨城県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 07 | Day |
Last modified on
| 2017 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034109
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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