UMIN-CTR Clinical Trial

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 Haruo Middle name Last name Fujino
Organization	United Graduate School of Child Development, Osaka University, Osaka University Hospital
Division name	Division of Developmental Neuroscience , Department of Pediatrics
Zip code	5650871
Address	2-2, Yamadaoka, Suita-shi,
TEL	06-6879-3863
Email	Fjinoh@kokoro.med.Osaka-u.ac.jp

Public contact
Name of contact person	1st name Miyuu Middle name Last name Matsui
Organization	United Graduate School of Child Development Osaka University
Division name	Division of Developmental Neuroscience
Zip code	5650871
Address	2-2, Yamadaoka, Suita-shi, Osaka
TEL	06-6879-3863
Homepage URL
Email	uyumiitsuma0125@gmail.com

Sponsor
Institute	United Graduate School of Child Development, Osaka University
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	United Graduate School of Child Development, Osaka University
Address	565-0871 2-2, Yamadaoka, Suita-shi, Osaka
Tel	06-6879-3863
Email	Fujinoh@kokoro.med.osaka-u.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	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	33
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	The pandemic of COVID-19 made it difficult to conduct parent training.
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	No longer recruiting
Date of protocol fixation	2019 Year 03 Month 01 Day
Date of IRB	2019 Year 03 Month 06 Day
Anticipated trial start date	2019 Year 03 Month 11 Day
Last follow-up date	2021 Year 05 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	2019 Year 03 Month 04 Day
Last modified on	2022 Year 03 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041093