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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023053
Receipt No. 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

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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
Email 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
Email fujiwara@mukogawa-u.ac.jp

Sponsor
Institute Osaka University Dental Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026571

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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