UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037072 |
|---|---|
| Receipt number | R000042244 |
| Scientific Title | Development and pilot evaluation of a peer-led parenting programme |
| Date of disclosure of the study information | 2019/06/17 |
| Last modified on | 2019/06/14 19:36:10 |
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Basic information
Public title
Development and pilot evaluation of a peer-led parenting programme
Acronym
Development and evaluation of Japanese version of EPEC
Scientific Title
Development and pilot evaluation of a peer-led parenting programme
Scientific Title:Acronym
Development and evaluation of Japanese version of EPEC
Region
| Japan |
Condition
Condition
non
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop the Japanese version of Empowering Parents Empowering Communities(EPEC), peer-led parenting programme, and evaluate the efficacy of the programme
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate parent's parenting style before and after intervetion
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
8 weekly 2-hour traing session
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Parents who have children aged 2 to 11 years old and some difficulties in child-rearing
Key exclusion criteria
Parents with some mental illness
Parents who are not able to participate all 8 sessions
Parents who are not native Japanese speaker
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yago |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Health Care Sciences
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-4511
sycfn@tm.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Yago |
Organization
Tokyo Medical and Dental University
Division name
Graduate School of Health Care Sciences
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-4511
Homepage URL
sycfn@tm.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental 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
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-4511
sycfn@tmd.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
| 2019 | Year | 06 | Month | 17 | 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
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 14 | Day |
Last modified on
| 2019 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042244
