UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063173 |
|---|---|
| Receipt number | R000072237 |
| Scientific Title | Exploring Digital Biomarkers for Postpartum Depression: A Prospective Observational Study Focusing on Infant Crying and Parental Cognition Bias |
| Date of disclosure of the study information | 2026/10/05 |
| Last modified on | 2026/10/04 22:34:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A smartphone app study exploring signs of postpartum depression from infant crying and parents' perceptions of it
Acronym
A BCI(Baby Cry Indicator) Study
Scientific Title
Exploring Digital Biomarkers for Postpartum Depression: A Prospective Observational Study Focusing on Infant Crying and Parental Cognition Bias
Scientific Title:Acronym
A BCI(Baby Cry Indicator) Study
Region
| Japan |
Condition
Condition
Postpartum depression
Classification by specialty
| Obstetrics and Gynecology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In caregivers of infants aged 0-12 months who use a smartphone parenting app, we will prospectively collect, for each infant crying event, the app's AI-based cry analysis results and the caregiver's subjective cognitive responses (perceived distress, urgency, emotional valence, and estimated crying duration). We will examine the associations of the discrepancy between the two (cognitive discrepancy) and of cry acoustic features with postpartum depressive symptoms (EPDS), and will explore, develop, and validate a digital biomarker for postpartum depression, the Baby Cry Indicator (BCI).
Basic objectives2
Others
Basic objectives -Others
Exploration of digital biomarkers and development and validation of a prediction model for postpartum depression
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence of an Edinburgh Postnatal Depression Scale (EPDS) total score of 9 or higher (at baseline immediately after enrollment and at follow-up 2 weeks or more after enrollment)
Key secondary outcomes
1. EPDS total score as a continuous variable (at baseline and follow-up)
2. Change in EPDS total score from baseline to follow-up, and transitions to and from EPDS positivity
3. Generalized Anxiety Disorder-7 (GAD-7) total score and presence of a score of 10 or higher (at baseline and follow-up)
4. Association with EPDS of the discrepancy (cognitive discrepancy) between caregivers' subjective ratings for each crying event (perceived distress, urgency, and emotional valence on 7-point scales, and estimated crying duration) and the app's Cry analysis results (at each crying event during the study period)
5. Association of cry acoustic features (e.g., fundamental frequency, F0) with EPDS
6. Predictive performance of the developed BCI: discrimination (AUC, sensitivity, specificity, F1, PR-AUC), calibration (Brier score, calibration curve), clinical utility (decision curve analysis), and incremental predictive value in hierarchical model comparison (change in AUC, NRI)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Users of the smartphone app "Awa Baby" who have agreed to its terms of use and privacy policy
2. Persons aged 16 years or older who are the primary caregivers of an infant aged 0 to 12 months, including corrected age (including mothers, fathers, grandparents, and other caregivers)
3. Persons able to understand and answer questionnaires in Japanese
4. Persons who have understood the explanation of the study purpose and data use, and have provided consent electronically
Key exclusion criteria
1. Persons who self-report having been diagnosed with a serious psychiatric disorder such as schizophrenia or bipolar disorder and currently receiving treatment for its acute phase
2. Persons whose collected acoustic data are of markedly low quality
3. Persons with missing responses to the EPDS or other questionnaires used for the primary outcome
4. Persons aged 16 to 17 years whose parent or guardian has declined their participation in the study
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Ohe |
Organization
The University of Tokyo
Division name
Artificial Intelligence and Digital Twin in Healthcare, Department of Medical
Zip code
113-0033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
ohe-office@adm.h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Tianyuan |
| Middle name | |
| Last name | Lyu |
Organization
The University of Tokyo
Division name
Department of Biomedical Informatics Division of Social Medicine Graduate School of Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
tlyu@m.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 10 | 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
| 2026 | Year | 10 | Month | 04 | Day |
Last modified on
| 2026 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072237
