UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040637 |
|---|---|
| Receipt number | R000046382 |
| Scientific Title | Verification of the effect of Positive Parenting Program for parents of Low Birth Weight infants in Transition to School |
| Date of disclosure of the study information | 2020/06/20 |
| Last modified on | 2020/06/03 12:06:21 |
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Basic information
Public title
Verification of the effect of Positive Parenting Program for parents of Low Birth Weight infants in Transition to School
Acronym
Verification of the effect of Positive Parenting Program for parents of Low Birth Weight infants in Transition to School
Scientific Title
Verification of the effect of Positive Parenting Program for parents of Low Birth Weight infants in Transition to School
Scientific Title:Acronym
Verification of the effect of Positive Parenting Program for parents of Low Birth Weight infants in Transition to School
Region
| Japan |
Condition
Condition
Low Birth Weight Infants
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify of the effect of Positive Parenting Program for parents of Low Birth Weight infants in Transition to School
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We conduct the seminars at two to three week intervals and immediately after the last seminar, we survey the program satisfaction.
Key secondary outcomes
1.Parenting Scale
2.Depression Anxiety Stress Scales
3.Problem Setting and Behaviour Checklist
4.Eyberg Child Behavior Inventory
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
| Other |
Interventions/Control_1
Positive Parenting Program level2
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
Male and Female
Key inclusion criteria
Parents who are rairing for a child with a low birth weight (birth weight less than 2500g) ,between 3 and 7 years of age.
Key exclusion criteria
When it becomes apparent that a relevant agency is intervening as a case of abuse or high risk of maltreatment.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | AYA |
| Middle name | |
| Last name | ISHIHARA |
Organization
Wakayama Medical University
Division name
Graduate School of Health and Nursing Science Doctoral Program
Zip code
641-0011
Address
580, Mikazura, Wakayama-shi
TEL
073-446-6700
n1412001@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | AYA |
| Middle name | |
| Last name | ISHIHARA |
Organization
Wakayama Medical University
Division name
Graduate School of Health and Nursing Science Doctoral Program
Zip code
641-0011
Address
580, Mikazura, Wakayama-shi
TEL
073-446-6700
Homepage URL
n1412001@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Hyogo University of Health Sciences
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
Wakayama Medical University
Address
580, Mikazura, Wakayama-shi
Tel
073-446-6700
n1412001@wakayama-med.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
| 2020 | Year | 06 | Month | 20 | 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
| 2020 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 06 | Month | 20 | 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
| 2020 | Year | 06 | Month | 03 | Day |
Last modified on
| 2020 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046382
