UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036072 |
|---|---|
| Receipt number | 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 | 2022/03/14 14:59:31 |
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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 | 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
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
uyumiitsuma0125@gmail.com
Sponsor or person
Institute
United Graduate School of Child Development, Osaka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041093
