UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023053 |
|---|---|
| Receipt number | R000026571 |
| Scientific Title | The interventional effect of Triple P; positive parenting program regarding mothers of children with cleft lip and/or palate |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2019/07/10 09:35:03 |
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Basic information
Public title
The interventional effect of Triple P; positive parenting program regarding mothers of children with cleft lip and/or palate
Acronym
The interventional effect of Triple P; positive parenting program regarding mothers of children with cleft lip and/or palate
Scientific Title
The interventional effect of Triple P; positive parenting program regarding mothers of children with cleft lip and/or palate
Scientific Title:Acronym
The interventional effect of Triple P; positive parenting program regarding mothers of children with cleft lip and/or palate
Region
| Japan |
Condition
Condition
Cleft Lip and/or Palate
Classification by specialty
| Oral surgery | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose was to clarify the interventional effect of Triple P regarding mothers of children with
cleft lip and/or palate, using psychological scales that measure anxiety of childrearing and parenting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measured Parenting Scale pre/post Triple P
Key secondary outcomes
Measured Strengths and Difficulties Questionnaire and Being a Parent Scales pre/post Triple P
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
| Maneuver |
Interventions/Control_1
Triple P form 5seminars and 3 phone-counselings
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Mothers of children with left lip and/or palate and participate in seminars of Triple P
Key exclusion criteria
Not applicable
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ike Miho |
Organization
Osaka University Dental Hospital
Division name
Nursing Department
Zip code
Address
1-8 Yamadaoka Suita Osaka Japan
TEL
06-6879-2382
ike@dent.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fujiwara Cheiko |
Organization
Mukogawa Women's University
Division name
School of Nursing
Zip code
Address
6-46 Ikebiraki-cho Nishinomiya-city Hyogo Japan
TEL
0798-39-9002
Homepage URL
fujiwara@mukogawa-u.ac.jp
Sponsor or person
Institute
Osaka University Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | 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
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 23 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 07 | Day |
Last modified on
| 2019 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026571
| 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 |
