UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056736 |
|---|---|
| Receipt number | R000064842 |
| Scientific Title | The Effects of Trauma-Informed Care E-learning for Partners of Pregnant Women: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2025/07/19 17:04:41 |
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Basic information
Public title
The Effects of Trauma-Informed Care E-learning for Partners of Pregnant Women: A Randomized Controlled Trial
Acronym
The Effects of Trauma-Informed Care E-learning for Partners of Pregnant Women: A Randomized Controlled Trial(TIC-Daddy)
Scientific Title
The Effects of Trauma-Informed Care E-learning for Partners of Pregnant Women: A Randomized Controlled Trial
Scientific Title:Acronym
The Effects of Trauma-Informed Care E-learning for Partners of Pregnant Women: A Randomized Controlled Trial (TIC-Daddy)
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the program is to provide a program for partners of pregnant women to learn about the concept of trauma-informed care, and to determine its effect on attitudes and practices toward trauma-informed care and its effect on the mental health of parents before and after childbirth.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The attitude related to trauma-informed acre (ARTIC-10 Japanese version)
Evaluation times: T1(before the intervention), T2(about one month after T1), T3(about three months after T1)
Key secondary outcomes
Quality Management Index (QMI)
Edinburgh Postnatal Depression Scale (EPDS)
Edinburgh Postpartum Depression Scale Partner (EPDS-P)
Evaluation times: T1(before the intervention), T2(about one month after T1), T3(about three months after T1)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) 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
(1) Definition of Trauma Informed Care, (2) Reactions to Traumatic Events, (3) Trauma Informed Care Practices, and (4) Self-Care, a four-part video program totaling approximately 60 minutes.
Interventions/Control_2
Control group: No treatment
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
Key inclusion criteria
Male who uses Kohoku Ward regional child-raising Base "Drop"
Pregnant woman as the partner is at less than 30 weeks of pregnancy."
Key exclusion criteria
N/A
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Nishi |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Mental Health
Zip code
1130033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3364
d-nishi@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Kanamori |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Psychiatric Nursing
Zip code
1130033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3364
Homepage URL
yokanamori@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
The Research Ethics Committee of the Graduate School of Medicine/Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 Japan
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2025 | Year | 02 | 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
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
| 2025 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 01 | Month | 16 | Day |
Last modified on
| 2025 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064842
