Table 2.
Enrolment | Allocation | Post-allocation | |||
---|---|---|---|---|---|
TIMEPOINT | T0 | 0 | 12 weeks follow-up (T1) | 24 weeks follow-up (T2) | |
ENROLMENT: | |||||
Eligibility screen | X | ||||
Informed consent | X | ||||
Allocation | X | ||||
INTERVENTIONS: | |||||
Intervention group | |||||
Control group | |||||
ASSESSMENTS: | Aim | ||||
Co-primary outcomes | |||||
EPDS | Maternal depressive symptoms | X | X | X | |
CTS-1 | Psychological aggression toward children | X | X | X | |
Secondary outcomes | |||||
Maternal | |||||
PHQ-9 | Depresssive symptoms | X | X | X | |
PSI-SF | Parent stress | X | X | X | |
MIBS-J | Mother-to-infant bonding | X | X | X | |
EQ-5D-5L | Quality of life | X | X | X | |
Use of inpatient and outpatient medical care in the past 3 months | Medical cost | X | X | X | |
Paediatric | |||||
Height, body weight | Physical development | X | X | X | |
Type of nutrition (breast milk, formula, both, baby food) | Nutritional status | X | X | X | |
Attendance of well-baby visits at 1, 3, 6–7, 9–10 months) | Health check-up status | X | X | X | |
Immunization record (Hib, pneumococcus, DPT-IPV, rotavirus, BCG) | Immunization status | X | X | X | |
Use of inpatient and outpatient medical care for injuries, foreign body ingestion, burn, and drowning in the 3 months | Medical cost for injuries | X | X | X | |
Implementation | |||||
Implementation outcome scale for Digital Mental Health (IDMH) for users | Acceptability, appropriateness, feasibility, overall satisfaction, and harms | X |
EPDS Edinburgh Postnatal Depression Scale, CTS-1 Conflict Tactics Scale, PHQ-9 Patient Heatlh Questionnaire-9, PSI-SF Parent stress index-short form Japanese version, MIBS-J Mother-to-Infant Bonding Scale Japanese version, EQ-5D-5L EuroQol-5 dimension-5 level