UMIN-CTR Clinical Trial

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
Email	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
Email	n1412001@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046382