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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046382


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name