UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013851 |
|---|---|
| Receipt number | R000016156 |
| Scientific Title | Development of Coaching program to prevent infants abuse for mothers |
| Date of disclosure of the study information | 2014/04/30 |
| Last modified on | 2014/05/20 19:01:52 |
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Basic information
Public title
Development of Coaching program to prevent infants abuse for mothers
Acronym
Coaching salivary cortisal trial
Scientific Title
Development of Coaching program to prevent infants abuse for mothers
Scientific Title:Acronym
Coaching salivary cortisal trial
Region
| Japan |
Condition
Condition
Not applicable(health)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effectiveness of coaching program to reduce biological stressindicator
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary Cortisol
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Behavior,custom |
Interventions/Control_1
The intervention group received group coaching. The intervention comprised five sessions over three months.
Interventions/Control_2
The control group received the coaching program post 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Mother of children aged 0-6 years.
Key exclusion criteria
Mental illness, Pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsura Toshiki |
Organization
Graduate School of Medicine, Kyoto University, Japan
Division name
Preventive Nursing
Zip code
Address
53 Shogoinkawaramachi, Sakyo-ku, Kyoto
TEL
81(75)751-3906
tkatsura@hs.med.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ohashi Junko |
Organization
Graduate School of Medicine, Kyoto University, Japan
Division name
Preventive Nursing
Zip code
Address
53,Shogoinkawaramachi, Sakyo-ku, Kyoto
TEL
81(75)751-3906
Homepage URL
oohashi.junko.82c@st.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University, Japan
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research from the Japan Society for the Promotion of Science.
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 30 | 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
| 2013 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | 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
| 2014 | Year | 04 | Month | 30 | Day |
Last modified on
| 2014 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016156
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
