UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032016 |
|---|---|
| Receipt number | R000036531 |
| Scientific Title | Influence of parenting guidance focusing on mother-child attachment relationship from childbirth immediately to mother and child: a randomized controlled Phase 2 trial. |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/04/02 09:25:33 |
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Basic information
Public title
Influence of parenting guidance focusing on mother-child attachment relationship from childbirth immediately to mother and child: a randomized controlled Phase 2 trial.
Acronym
A study on the influence of parenting guidance on mother and child.
Scientific Title
Influence of parenting guidance focusing on mother-child attachment relationship from childbirth immediately to mother and child: a randomized controlled Phase 2 trial.
Scientific Title:Acronym
A study on the influence of parenting guidance on mother and child.
Region
| Japan |
Condition
Condition
Puerperant
Healthy child
Classification by specialty
| Obstetrics and Gynecology | Pediatrics | Psychiatry |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I show that parenting guidance from immediately after child birth reduces mothers' child rearing stress.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Parenting Stress Index Short Form(PSI-SF) of mothers one year after childbirth
Key secondary outcomes
1.Enjyoji's Development Scale in Evaluating the Development
2.Height and weight of child
3.Sleeping time of mother and child
4.Presence of child's crying at night
5.The Japanese Version of Client Satisfaction Questionnaire(Intervention group only)
(one year after giving birth)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Interventions: Three parenting guidance (immediately after birth, 3 months, 6 months later) will be conducted from the time of participation to 1 year after birth
Interventions/Control_2
Control: no interventions
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
Puerperant and baby born at Wakayama Rosai Hospital
Key exclusion criteria
1.Child side factor
Immediately after birth, hospitalization becomes necessary at NICU
2.mother side factor
When delivery is required to other medical institutions at birth
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Omoto |
Organization
Wakayama Rosai Hospital
Division name
Pediatrics
Zip code
640-8505
Address
93-1 Kinomoto, Wakayama, Wakayama, Japan
TEL
073-451-3181
hra-oomoto@wakayamah.johas.go.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Omoto |
Organization
Wakayama Rosai Hospital
Division name
Pediatrics
Zip code
640-8505
Address
93-1 Kinomoto, Wakayama, Wakayama, Japan
TEL
073-451-3181
Homepage URL
hra-oomoto@wakayamah.johas.go.jp
Sponsor or person
Institute
Pediatrics, Wakayama Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Rosai Hospital
Address
Wakayama City Kinomoto 93-1
Tel
073-451-3181
hra-oomoto@wakayamah.johas.go.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
| 2018 | Year | 04 | Month | 01 | 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
200
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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2018 | Year | 03 | Month | 30 | Day |
Last modified on
| 2020 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036531
