Tokyo, Oct. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063173) titled 'A smartphone app study exploring signs of postpartum depression from infant crying and parents' perceptions of it' on Oct. 5.

Study Type: Observational

Primary Sponsor: Institute - The University of Tokyo

Condition: Condition - Postpartum depression Classification by malignancy - Others Genomic information - NO

Objective: 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

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 Size - 600

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072237

Disclaimer: Curated by HT Syndication.