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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036072
Receipt No. R000041093
Scientific Title Effect of parent training to the parent having the child discharged from the NICU.
Date of disclosure of the study information 2019/03/05
Last modified on 2019/03/04

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Basic information
Public title Effect of parent training to the parent having the child discharged from the NICU.
Acronym Effect of the parent training on parent of the premature infant.
Scientific Title Effect of parent training to the parent having the child discharged from the NICU.
Scientific Title:Acronym Effect of the parent training on parent of the premature infant.
Region
Japan

Condition
Condition Preterm infant
Parents who feels difficulty for their child care
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We performed parent training to the parent of a child discharged from the NICU and evaluated the change of child behavior, confidence of child care, stress of child care with video analysis, question paper, interview and cortisol of saliva measurement.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Parenting Stress Index
Key secondary outcomes Child Behavior Checklist
Social Responsiveness Score
Vineland Adaptive Behavior Scales, Second Edition
Confidence questionnaire of child care
Cortisol of saliva measurement

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 We divided parent training into four times for intervention group and carried it out.
One session took 90 minutes and went this every other week.
Interventions/Control_2 To intervention 2, We arranged three months as a non-intervention period and carried out similar parent training.
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
24 months-old <=
Age-upper limit
47 months-old >=
Gender Male and Female
Key inclusion criteria Gestational age 30-36 weeks
Birth weight 1000-2500g
Kyoto Scale of Psychological Development DQ more than 70 points
Key exclusion criteria Multiple birth.
Complications of the child:Neurologic disease with severe development delay, chromosomal abnormality, congenital anomaly syndrome.
For a child, some kind of support and nursing programs or treatment has been already started.
Parents have a serious mental disease or need socially some kind of urgent correspondence.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroko Okuno
Organization United Graduate School of Child Development, Osaka University
Division name Division of Developmental Neuroscience
Zip code
Address 565-0871 2-2, Yamadaoka, Suita-shi,
TEL 06-6879-3863
Email okuno.h@kokoro.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miyuu Matsui
Organization United Graduate School of Child Development Osaka University , Osaka University Hospital
Division name Division of Developmental Neuroscience , Department of Pediatrics
Zip code
Address 565-0871 2-2, Yamadaoka, Suita-shi, Osaka
TEL 06-6879-3863
Homepage URL
Email uyumiitsuma0125@gmail.com

Sponsor
Institute United Graduate School of Child Development
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2019 Year 03 Month 05 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
2019 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 04 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041093

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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