UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000036531