UMIN-CTR Clinical Trial

Basic information
Public title	A study on the effect of childcare support services on QOL and postpartum depression and a examination of services for pregnant and postpartum women.
Acronym	A study on the effect of childcare support services on QOL and postpartum depression and a examination of services for pregnant and postpartum women.
Scientific Title	A study on the effect of childcare support services on QOL and postpartum depression and a examination of services for pregnant and postpartum women.
Scientific Title:Acronym	A study on the effect of childcare support services on QOL and postpartum depression and a examination of services for pregnant and postpartum women.
Region	Japan

Condition
Condition	Postpartum depression
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the effects of continuous use of the childcare support service (communication robot (BOCCO emo)) from pregnancy to postpartum on quality of life and prevent and improve depressive condition, and to conduct a feasibility investigation of the service.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	WHO-5(simplified Japanese version of the WHO-Five Well-being Index) change in total score from baseline to each time point(36 weeks gestation, 1 and 3 months postpartum).
Key secondary outcomes	(1)EPDS(Edinburgh Postnatal Depression Scale) change in total score from baseline to each time point. (2)Number of consultations with local maternal and child health centers(36 weeks gestation, 1 and 3 months postpartum). (3)Satisfaction with overall service, continued use, recommendation, frequency of use, intention to pay for service, financial knowledge and insurance consultation needs based on questionnaire responses regarding service, etc.

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
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	The intervention group will receive the communication robot (BOCCO emo) at 30 weeks of pregnancy after consent is confirmed, and the intervention will start as soon as it arrives. The service will continue to be available until 3 months after delivery. In addition to the parenting support services, online counseling (up to 2 times), online midwife/nursery consultation (up to 2 times), and online medical care (free of charge up to the appointment, actual cost for medical care) are also available. The frequency of use and services can be selected according to the preferences of the research subjects.
Interventions/Control_2	The control group will not use the parenting support services.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Persons who meet all of the following criteria will be considered for this study. (1) The women who are in the second trimester of pregnancy and pregnant with their first child at the time of obtaining consent. (2) Persons who agree with the content of this study and have given their consent to participate in the study. (3) Have a Wi-Fi environment at home and be able to set up the communication robot at home and connect to Wi-Fi throughout the study period. (4) Persons who are able to download and use the dedicated application on their own smartphones. (5) Persons who can understand the Japanese language described in the consent document and the questionnaire.
Key exclusion criteria	Persons who meet any of the following criteria will be excluded from this study. (1) Persons who require a surrogate. (2) Persons who plan to live with their mother, father, mother-in-law, father-in-law, or supporter during the first 3 months after childbirth. (3) Persons who are under treatment for depression or psychiatric disorders. (4) Other persons who are judged to be inappropriate to participate in this study by the principal investigator or co-Investigators.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yoshiyuki Middle name Last name Tachibana
Organization	National Center for Child Health and Development
Division name	Division of Infant and Toddler Mental Health, Department of Psychosocial Medicine
Zip code	1578535
Address	2-10-1 Okura,Setagaya-ku,Tokyo
TEL	03-3416-0181
Email	tachibana-y@ncchd.go.jp

Public contact
Name of contact person	1st name Miwa Middle name Last name Takai
Organization	National Center for Child Health and Development
Division name	Division of Infant and Toddler Mental Health, Department of Psychosocial Medicine
Zip code	1578535
Address	2-10-1 Okura,Setagaya-ku,Tokyo
TEL	03-3416-0181
Homepage URL
Email	boccoemo@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
Institute
Department

Funding Source
Organization	SUMITOMO LIFE INSURANCE COMPANY
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Review Board, National Center for Child Health and Development
Address	2-10-1 Okura,Setagaya-ku,Tokyo
Tel	03-3416-0181
Email	rinri@ncchd.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	国立成育医療研究センター（東京都）

Other administrative information
Date of disclosure of the study information	2022 Year 09 Month 14 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
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	Preinitiation
Date of protocol fixation	2022 Year 09 Month 08 Day
Date of IRB	2022 Year 09 Month 08 Day
Anticipated trial start date	2022 Year 09 Month 15 Day
Last follow-up date	2023 Year 12 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	2022 Year 09 Month 14 Day
Last modified on	2022 Year 09 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054865