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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032016
Receipt No. 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

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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
Obsterics 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
Email 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
Email hra-oomoto@wakayamah.johas.go.jp

Sponsor
Institute Pediatrics, Wakayama Rosai Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036531

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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